Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT02304432
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2014-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003523', 'term': 'Cycloserine'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dlevy@mclean.harvard.edu', 'phone': '617-855-2854', 'title': 'Dr. Deborah Levy', 'organization': 'McLean Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '48 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Open Label DCS', 'description': 'Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DCS (Crossover)', 'description': 'Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 6 weeks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PLACEBO (CROSSOVER)', 'description': 'Both participants received placebo for 6 weeks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Second Open Label DCS', 'description': 'Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule for 24 weeks.\n\nD-cycloserine: Both participants received second open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Positive and Negative Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Open Label DCS', 'description': 'Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.'}, {'id': 'OG001', 'title': 'Second Open Label DCS', 'description': 'Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.'}], 'classes': [{'title': 'Baseline positive', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '17'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '13'}]}]}, {'title': 'Baseline negative', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '18'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '17'}]}]}, {'title': '2 weeks positive', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '11'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '13'}]}]}, {'title': '2 weeks negative', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '15'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '17'}]}]}, {'title': '4 weeks positive', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '11'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '12'}]}]}, {'title': '4 weeks negative', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '15'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '16'}]}]}, {'title': '6 weeks positive', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '10'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '10'}]}]}, {'title': '6 weeks negative', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '15'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '15'}]}]}, {'title': '8 weeks positive', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '10'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '11'}]}]}, {'title': '8 weeks negative', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '15'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': '10 weeks positive', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '11'}]}]}, {'title': '10 weeks negative', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '15'}]}]}, {'title': '12 weeks positive', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '13'}]}]}, {'title': '12 weeks negative', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': '14 weeks positive', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '12'}]}]}, {'title': '14 weeks negative', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': '16 weeks positive', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '11'}]}]}, {'title': '16 weeks negative', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': '18 weeks positive', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '12'}]}]}, {'title': '18 weeks negative', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': '20 weeks positive', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '12'}]}]}, {'title': '20 weeks negative', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': '22 weeks positive', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '11'}]}]}, {'title': '22 weeks negative', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': '24 weeks positive', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '12'}]}]}, {'title': '24 weeks negative', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2', 'description': 'Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Positive and Negative Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo First, Then DCS', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial\n\nRandomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.\n\nD-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.\n\nDCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks.'}, {'id': 'OG001', 'title': 'DCS First, Then Placebo', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial'}], 'classes': [{'title': 'Baseline positive for first intervention', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Baseline negative symptoms for first intervention', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': '2 weeks positive for first intervention', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '2 weeks negative for first intervention', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': '4 weeks positive for first intervention', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '4 weeks negative for first intervention', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': '6 weeks positive for first intervention', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '6 weeks negative for first intervention', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline positive for second intervention', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline negative for second intervention', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '2 weeks positive for second intervention', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': '2 weeks negative for second intervention', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '4 weeks positive for second intervention', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': '4 weeks negative for second intervention', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '6 weeks positive for second intervention', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '6 weeks negative for second intervention', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 2, 4, & 6 weeks (crossover periods)', 'description': 'Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Brief Psychiatric Rating Scale (BPRS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Open Label DCS', 'description': 'Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.'}, {'id': 'OG001', 'title': 'Second Open Label DCS', 'description': 'Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.'}], 'classes': [{'title': 'Baseline BPRS', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '40'}, {'value': '31.5', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '35'}]}]}, {'title': '2 weeks BPRS', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '28'}, {'value': '30.5', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '34'}]}]}, {'title': '4 weeks BPRS', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '28'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '29'}]}]}, {'title': '6 weeks BPRS', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '26'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '26'}]}]}, {'title': '8 weeks BPRS', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '26'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '28'}]}]}, {'title': '10 weeks BPRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '27'}]}]}, {'title': '12 weeks BPRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '28'}]}]}, {'title': '14 weeks BPRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '27'}]}]}, {'title': '16 weeks BPRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '30'}]}]}, {'title': '18 weeks BPRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '29'}]}]}, {'title': '20 weeks BPRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '27'}]}]}, {'title': '22 weeks BPRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '24.5', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '27'}]}]}, {'title': '24 weeks BPRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2', 'description': 'Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Brief Psychiatric Rating Scale (BPRS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo First, Then DCS', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial\n\nRandomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.\n\nD-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.\n\nDCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks.'}, {'id': 'OG001', 'title': 'DCS First, Then Placebo', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial'}], 'classes': [{'title': 'Baseline BPRS for first intervention', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': '2 weeks BPRS for first intervention', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': '4 weeks BPRS for first intervention', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': '6 weeks BPRS for first intervention', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Baseline BPRS for second intervention', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': '2 weeks BPRS for second intervention', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': '4 weeks BPRS for second intervention', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': '6 weeks BPRS for second intervention', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 2, 4, & 6 weeks (crossover periods)', 'description': 'Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clinical Global Impression (CGI) Severity Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Open Label DCS', 'description': 'Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.'}, {'id': 'OG001', 'title': 'Second Open Label DCS', 'description': 'Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.'}], 'classes': [{'title': 'Baseline CGI', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '4'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '2 weeks CGI', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '4 weeks CGI', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '6 weeks CGI', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '8 weeks CGI', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '10 weeks CGI', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}, {'title': '12 weeks CGI', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '14 weeks CGI', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '2'}]}]}, {'title': '16 weeks CGI', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '18 weeks CGI', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '20 weeks CGI', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '22 weeks CGI', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '24 weeks CGI', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2', 'description': 'CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clinical Global Impression (CGI) Severity Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo First, Then DCS', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial\n\nRandomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.\n\nD-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.\n\nDCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks.'}, {'id': 'OG001', 'title': 'DCS First, Then Placebo', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial'}], 'classes': [{'title': 'Baseline CGI for first intervention', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '2 weeks CGI for first intervention', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '4 weeks CGI for first intervention', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '6 weeks CGI for first intervention', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline CGI for second intervention', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '2 weeks CGI for second intervention', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '4 weeks CGI for second intervention', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '6 weeks CGI for second intervention', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 2, 4, & 6 weeks (crossover periods)', 'description': 'CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mania Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Open Label DCS', 'description': 'Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.'}, {'id': 'OG001', 'title': 'Second Open Label DCS', 'description': 'Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.'}], 'classes': [{'title': 'Baseline YMRS', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '2 weeks YMRS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '4 weeks YMRS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '6 weeks YMRS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '8 weeks YMRS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '10 weeks YMRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '12 weeks YMRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '14 weeks YMRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '16 weeks YMRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '18 weeks YMRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '20 weeks YMRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '22 weeks YMRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '24 weeks YMRS', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2', 'description': 'Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Depression Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Open Label DCS', 'description': 'Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.'}, {'id': 'OG001', 'title': 'Second Open Label DCS', 'description': 'Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.'}], 'classes': [{'title': 'Baseline HAM', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': '2 weeks HAM', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1'}]}]}, {'title': '4 weeks HAM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': '6 weeks HAM', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '8 weeks HAM', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': '10 weeks HAM', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '12 weeks HAM', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '14 weeks HAM', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '16 weeks HAM', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': '18 weeks HAM', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '20 weeks HAM', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '22 weeks HAM', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '24 weeks HAM', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This open label period lasted only 8 weeks, so no additional data were collected for this time point.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2', 'description': 'Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mania Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo First, Then DCS', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial\n\nRandomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.\n\nD-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.\n\nDCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks.'}, {'id': 'OG001', 'title': 'DCS First, Then Placebo', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial'}], 'classes': [{'title': 'Baseline YMRS for first intervention', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 weeks YMRS for first intervention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4 weeks YMRS for first intervention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6 weeks YMRS for first intervention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline YMRS for second intervention', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 weeks YMRS for second intervention', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4 weeks YMRS for second intervention', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6 weeks YMRS for second intervention', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 2, 4, & 6 weeks (crossover periods)', 'description': 'Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Depression Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo First, Then DCS', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial\n\nRandomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.\n\nD-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.\n\nDCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks.'}, {'id': 'OG001', 'title': 'DCS First, Then Placebo', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial'}], 'classes': [{'title': 'Baseline HAM for first intervention', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 weeks HAM for first intervention', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '4 weeks HAM for first intervention', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6 weeks HAM for first intervention', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline HAM for second intervention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '2 weeks HAM for second intervention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '4 weeks HAM for second intervention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '6 weeks HAM for second intervention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 2, 4, & 6 weeks (crossover periods)', 'description': 'Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label DCS', 'description': 'During the first open label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks. During the second open-label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks. One subject was tested at the beginning of week 8 of the first open-label period and the other subject was tested at the beginning of week 8 of the second open-label period.'}], 'classes': [{'title': 'Baseline Processing Speed', 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '54'}]}]}, {'title': 'Baseline Attention/Vigilance', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '50'}]}]}, {'title': 'Baseline Working Memory', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '38', 'upperLimit': '39'}]}]}, {'title': 'Baseline Verbal Learning', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '63'}]}]}, {'title': 'Baseline Visual Learning', 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '51'}]}]}, {'title': 'Baseline Reasoning/Problem Solving', 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '53'}]}]}, {'title': 'Baseline Social Cognition', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '52'}]}]}, {'title': 'Baseline Overall Composite Score', 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '48'}]}]}, {'title': 'Week 8 of open-label DCS Processing Speed', 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '54'}]}]}, {'title': 'Week 8 of open-label DCS Attention/Vigilance', 'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '56'}]}]}, {'title': 'Week 8 of open-label DCS Working Memory', 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '52'}]}]}, {'title': 'Week 8 of open-label DCS Verbal Learning', 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '45'}]}]}, {'title': 'Week 8 of open-label DCS Visual Learning', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '58'}]}]}, {'title': 'Week 8 of open-label DCS Reasoning/Problem Solving', 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '68'}]}]}, {'title': 'Week 8 of open-label DCS Social Cognition', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '47'}]}]}, {'title': 'Week 8 of open-label DCS Overall Composite Score', 'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '54'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 8 of open-label DCS treatment', 'description': 'Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution, standard deviation of 10. Higher scores signify better functioning.', 'unitOfMeasure': 'T scores', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The on DCS data were collected during week 8 of the first open-label portion of the study in one subject and in week 8 of the second open-label portion of the study in the other subject for logistical reasons.'}, {'type': 'SECONDARY', 'title': 'Brain Glycine/CR Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label DCS', 'description': 'During the first open label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks. During the second open-label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks. OOne subject was tested at the beginning of week 8 of the first open-label period and the other subject was tested at the beginning of week 8 of the second open-label period.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.41245', 'groupId': 'OG000', 'lowerLimit': '0.2558', 'upperLimit': '0.5691'}]}]}, {'title': 'Baseline at 60 minutes', 'categories': [{'measurements': [{'value': '0.50375', 'groupId': 'OG000', 'lowerLimit': '0.3918', 'upperLimit': '0.6157'}]}]}, {'title': 'Baseline at 80 minutes', 'categories': [{'measurements': [{'value': '0.65295', 'groupId': 'OG000', 'lowerLimit': '0.6428', 'upperLimit': '0.6631'}]}]}, {'title': 'Baseline at 100 minutes', 'categories': [{'measurements': [{'value': '0.61505', 'groupId': 'OG000', 'lowerLimit': '0.5938', 'upperLimit': '0.6363'}]}]}, {'title': 'Baseline at 120 minutes', 'categories': [{'measurements': [{'value': '0.8256', 'groupId': 'OG000', 'lowerLimit': '0.6953', 'upperLimit': '0.9559'}]}]}, {'title': 'Week 8 of DCS: Baseline', 'categories': [{'measurements': [{'value': '0.10977', 'groupId': 'OG000', 'lowerLimit': '0.00007', 'upperLimit': '0.21947'}]}]}, {'title': 'Week 8 of DCS: 60 minutes', 'categories': [{'measurements': [{'value': '0.248885', 'groupId': 'OG000', 'lowerLimit': '0.24294', 'upperLimit': '0.25483'}]}]}, {'title': 'Week 8 of DCS: 80 minutes', 'categories': [{'measurements': [{'value': '0.32609', 'groupId': 'OG000', 'lowerLimit': '0.24571', 'upperLimit': '0.40647'}]}]}, {'title': 'Week 8 of DCS: 100 minutes', 'categories': [{'measurements': [{'value': '0.32052', 'groupId': 'OG000', 'lowerLimit': '0.24289', 'upperLimit': '0.39815'}]}]}, {'title': 'Week 8 of DCS: 120 minutes', 'categories': [{'measurements': [{'value': '0.312155', 'groupId': 'OG000', 'lowerLimit': '0.1903', 'upperLimit': '0.43401'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 8 of DCS treatment', 'description': 'Proton magnetic resonance spectroscopy at 4T: brain glycine/CR ratio. Participants were assessed at baseline (pre-glycine challenge dose and 60, 80, 100 and 120 minutes post glycine dose) and in week 8 of of open-label DCS treatment: pre-DCS dose, and 60, 80, 100 and 120 minutes post DCS dose. Measured in posterior occipital cortex.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected only during only one of the open label periods for financial and logistical reasons. Data were collected in week 8 of the first open-label DCS exposure in one subject and in week 8 of the second open-label DCS exposure in the other subject for logistical reasons.'}, {'type': 'SECONDARY', 'title': 'Auditory Evoked Potentials in Latency (Msec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'First Open Label DCS', 'description': 'The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.'}], 'classes': [{'title': 'P300 at fz: Baseline', 'categories': [{'measurements': [{'value': '279.297', 'groupId': 'OG000'}]}]}, {'title': 'P300 at cz: Baseline', 'categories': [{'measurements': [{'value': '279.297', 'groupId': 'OG000'}]}]}, {'title': 'P300 at pz: Baseline', 'categories': [{'measurements': [{'value': '279.297', 'groupId': 'OG000'}]}]}, {'title': 'N100 at fz: Baseline', 'categories': [{'measurements': [{'value': '97.656', 'groupId': 'OG000'}]}]}, {'title': 'N100 at cz: Baseline', 'categories': [{'measurements': [{'value': '91.797', 'groupId': 'OG000'}]}]}, {'title': 'P200 at fz: Baseline', 'categories': [{'measurements': [{'value': '197.266', 'groupId': 'OG000'}]}]}, {'title': 'P200 at cz: Baseline', 'categories': [{'measurements': [{'value': '193.359', 'groupId': 'OG000'}]}]}, {'title': 'P300 at fz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '294.920', 'groupId': 'OG000'}]}]}, {'title': 'P300 at cz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '294.000', 'groupId': 'OG000'}]}]}, {'title': 'P300 at pz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '294', 'groupId': 'OG000'}]}]}, {'title': 'N100 at fz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000'}]}]}, {'title': 'N100 at cz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '88.000', 'groupId': 'OG000'}]}]}, {'title': 'P200 at fz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '212.890', 'groupId': 'OG000'}]}]}, {'title': 'P200 at cz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '212.000', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8 of DCS treatment', 'description': 'Auditory evoked potential latency: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz.', 'unitOfMeasure': 'msec', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one subject had normal hearing, which is required for valid data collection.'}, {'type': 'SECONDARY', 'title': 'Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'First Open Label DCS', 'description': 'The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.'}], 'classes': [{'title': 'P300 at fz: Baseline', 'categories': [{'measurements': [{'value': '-0.635', 'groupId': 'OG000'}]}]}, {'title': 'P300 at cz: Baseline', 'categories': [{'measurements': [{'value': '6.529', 'groupId': 'OG000'}]}]}, {'title': 'P300 at pz: Baseline', 'categories': [{'measurements': [{'value': '5.340', 'groupId': 'OG000'}]}]}, {'title': 'N100 at fz: Baseline', 'categories': [{'measurements': [{'value': '-3.926', 'groupId': 'OG000'}]}]}, {'title': 'N100 at cz: Baseline', 'categories': [{'measurements': [{'value': '-3.615', 'groupId': 'OG000'}]}]}, {'title': 'P200 at fz: Baseline', 'categories': [{'measurements': [{'value': '1.662', 'groupId': 'OG000'}]}]}, {'title': 'P200 at cz: Baseline', 'categories': [{'measurements': [{'value': '6.591', 'groupId': 'OG000'}]}]}, {'title': 'P50 S1: Baseline', 'categories': [{'measurements': [{'value': '2.759', 'groupId': 'OG000'}]}]}, {'title': 'P50 S2: Baseline', 'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'MMN at fz: Baseline', 'categories': [{'measurements': [{'value': '-3.356', 'groupId': 'OG000'}]}]}, {'title': 'MMN at cz: Baseline', 'categories': [{'measurements': [{'value': '-4.130', 'groupId': 'OG000'}]}]}, {'title': 'P300 at fz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '3.030', 'groupId': 'OG000'}]}]}, {'title': 'P300 at cz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '6.810', 'groupId': 'OG000'}]}]}, {'title': 'P300 at pz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '6.620', 'groupId': 'OG000'}]}]}, {'title': 'N100 at fz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '-3.260', 'groupId': 'OG000'}]}]}, {'title': 'N100 at cz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '-3.940', 'groupId': 'OG000'}]}]}, {'title': 'P200 at fz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '8.200', 'groupId': 'OG000'}]}]}, {'title': 'P200 at cz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '8.160', 'groupId': 'OG000'}]}]}, {'title': 'P50 S1: Week 8 of DCS', 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000'}]}]}, {'title': 'P50 S2: Week 8 of DCS', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'MMN at fz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '-3.330', 'groupId': 'OG000'}]}]}, {'title': 'MMN at cz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '-1.540', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8 of DCS treatment', 'description': 'Auditory evoked potential amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2; mismatch negativity (MMN) at fz and cz.', 'unitOfMeasure': 'microvolts', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one subject had normal hearing, which is required for valid data collection.'}, {'type': 'SECONDARY', 'title': 'Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'First Open Label DCS', 'description': 'The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.'}], 'classes': [{'title': 'G40 hz phase locking at fz: Baseline', 'categories': [{'measurements': [{'value': '0.135', 'groupId': 'OG000'}]}]}, {'title': 'G40 hz phase locking at cz: Baseline', 'categories': [{'measurements': [{'value': '0.168', 'groupId': 'OG000'}]}]}, {'title': 'G30 hz phase locking at fz: Baseline', 'categories': [{'measurements': [{'value': '0.190', 'groupId': 'OG000'}]}]}, {'title': 'G30 hz phase locking at cz: Baseline', 'categories': [{'measurements': [{'value': '0.163', 'groupId': 'OG000'}]}]}, {'title': 'G20 hz phase locking at fz: Baseline', 'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000'}]}]}, {'title': 'G20 hz phase locking at cz: Baseline', 'categories': [{'measurements': [{'value': '0.030', 'groupId': 'OG000'}]}]}, {'title': 'G40 hz phase locking at fz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '0.344', 'groupId': 'OG000'}]}]}, {'title': 'G40 hz phase locking at cz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '0.381', 'groupId': 'OG000'}]}]}, {'title': 'G30 hz phase locking at fz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '0.168', 'groupId': 'OG000'}]}]}, {'title': 'G30 hz phase locking at cz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'G20 hz phase locking at fz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}]}]}, {'title': 'G20 hz phase locking at cz: Week 8 of DCS', 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8 of DCS treatment', 'description': 'Auditory evoked potential gamma: G40 hz phase locking at fz and cz; G30 hz phase locking at fz and cz; G20 hz phase locking at fz and cz', 'unitOfMeasure': 'microvolts squared', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one subject had normal hearing, which is required for valid data collection.'}, {'type': 'SECONDARY', 'title': 'Auditory Evoked Potentials - P50 Ratio (P50 S2/S1) (Amplitude)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'First Open Label DCS', 'description': 'The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.'}], 'classes': [{'title': 'P50 ratio: Baseline', 'categories': [{'measurements': [{'value': '44.51', 'groupId': 'OG000'}]}]}, {'title': 'P50 ratio: Week 8 of DCS', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 8 of DCS treatment', 'description': 'Auditory evoked potential amplitude: P50 ratio (P50 S2/S1)', 'unitOfMeasure': 'ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one subject had normal hearing, which is required for valid data collection.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label DCS', 'description': 'Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule for 8 weeks.\n\nD-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.'}, {'id': 'FG001', 'title': 'Placebo First, Then DCS', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial\n\nRandomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.\n\nD-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.\n\nDCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks.'}, {'id': 'FG002', 'title': 'DCS First, Then Placebo', 'description': 'One of the sequences during the DB period; dose of DCS, freq of admin; length of trial'}, {'id': 'FG003', 'title': 'Second Open Label DCS', 'description': 'Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule for 24 weeks.\n\nD-cycloserine: Both participants received second open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.'}], 'periods': [{'title': 'Open Label DCS', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Double-Blind DCS Placebo Crossover', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Second Open Label DCS', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule for 8 weeks.\n\nD-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.\n\nAdd crossover phase and second OL phase'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '62'}]}]}], 'paramType': 'MEAN', 'description': 'age at beginning of study', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-09', 'size': 679109, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-07-28T19:55', 'hasProtocol': False}, {'date': '2015-04-09', 'size': 532036, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-07-28T19:56', 'hasProtocol': True}, {'date': '2015-02-27', 'size': 527022, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-07-29T12:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-18', 'studyFirstSubmitDate': '2014-11-26', 'resultsFirstSubmitDate': '2017-07-31', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-18', 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive and Negative Symptom Scores', 'timeFrame': 'Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2', 'description': 'Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.'}, {'measure': 'Positive and Negative Symptom Scores', 'timeFrame': 'Baseline, 2, 4, & 6 weeks (crossover periods)', 'description': 'Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.'}, {'measure': 'Brief Psychiatric Rating Scale (BPRS) Scores', 'timeFrame': 'Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2', 'description': 'Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.'}, {'measure': 'Brief Psychiatric Rating Scale (BPRS) Scores', 'timeFrame': 'Baseline, 2, 4, & 6 weeks (crossover periods)', 'description': 'Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.'}, {'measure': 'Clinical Global Impression (CGI) Severity Scores', 'timeFrame': 'Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2', 'description': 'CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.'}, {'measure': 'Clinical Global Impression (CGI) Severity Scores', 'timeFrame': 'Baseline, 2, 4, & 6 weeks (crossover periods)', 'description': 'CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.'}, {'measure': 'Mania Symptom Scores', 'timeFrame': 'Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2', 'description': 'Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.'}, {'measure': 'Depression Symptom Scores', 'timeFrame': 'Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2', 'description': 'Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.'}, {'measure': 'Mania Symptom Scores', 'timeFrame': 'Baseline, 2, 4, & 6 weeks (crossover periods)', 'description': 'Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.'}, {'measure': 'Depression Symptom Scores', 'timeFrame': 'Baseline, 2, 4, & 6 weeks (crossover periods)', 'description': 'Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.'}], 'secondaryOutcomes': [{'measure': 'Neurocognitive Function', 'timeFrame': 'Baseline and Week 8 of open-label DCS treatment', 'description': 'Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution, standard deviation of 10. Higher scores signify better functioning.'}, {'measure': 'Brain Glycine/CR Ratio', 'timeFrame': 'Baseline and Week 8 of DCS treatment', 'description': 'Proton magnetic resonance spectroscopy at 4T: brain glycine/CR ratio. Participants were assessed at baseline (pre-glycine challenge dose and 60, 80, 100 and 120 minutes post glycine dose) and in week 8 of of open-label DCS treatment: pre-DCS dose, and 60, 80, 100 and 120 minutes post DCS dose. Measured in posterior occipital cortex.'}, {'measure': 'Auditory Evoked Potentials in Latency (Msec)', 'timeFrame': 'Baseline and Week 8 of DCS treatment', 'description': 'Auditory evoked potential latency: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz.'}, {'measure': 'Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)', 'timeFrame': 'Baseline and Week 8 of DCS treatment', 'description': 'Auditory evoked potential amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2; mismatch negativity (MMN) at fz and cz.'}, {'measure': 'Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)', 'timeFrame': 'Baseline and Week 8 of DCS treatment', 'description': 'Auditory evoked potential gamma: G40 hz phase locking at fz and cz; G30 hz phase locking at fz and cz; G20 hz phase locking at fz and cz'}, {'measure': 'Auditory Evoked Potentials - P50 Ratio (P50 S2/S1) (Amplitude)', 'timeFrame': 'Baseline and Week 8 of DCS treatment', 'description': 'Auditory evoked potential amplitude: P50 ratio (P50 S2/S1)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['D-cycloserine', 'Glycine', 'Psychosis', 'Mutation', 'GABA'], 'conditions': ['Schizophrenia', 'Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '19883952', 'type': 'BACKGROUND', 'citation': 'Sebat J, Levy DL, McCarthy SE. 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Quantification of J-resolved proton spectra in two-dimensions with LCModel using GAMMA-simulated basis sets at 4 Tesla. NMR Biomed. 2009 Aug;22(7):762-9. doi: 10.1002/nbm.1390.'}, {'pmid': '18602089', 'type': 'BACKGROUND', 'citation': 'Ongur D, Jensen JE, Prescot AP, Stork C, Lundy M, Cohen BM, Renshaw PF. Abnormal glutamatergic neurotransmission and neuronal-glial interactions in acute mania. Biol Psychiatry. 2008 Oct 15;64(8):718-726. doi: 10.1016/j.biopsych.2008.05.014. Epub 2008 Jul 7.'}, {'pmid': '15474895', 'type': 'RESULT', 'citation': 'Duncan EJ, Szilagyi S, Schwartz MP, Bugarski-Kirola D, Kunzova A, Negi S, Stephanides M, Efferen TR, Angrist B, Peselow E, Corwin J, Gonzenbach S, Rotrosen JP. Effects of D-cycloserine on negative symptoms in schizophrenia. Schizophr Res. 2004 Dec 1;71(2-3):239-48. doi: 10.1016/j.schres.2004.03.013.'}, {'pmid': '31279534', 'type': 'DERIVED', 'citation': 'Bodkin JA, Coleman MJ, Godfrey LJ, Carvalho CMB, Morgan CJ, Suckow RF, Anderson T, Ongur D, Kaufman MJ, Lewandowski KE, Siegel AJ, Waldstreicher E, Grochowski CM, Javitt DC, Rujescu D, Hebbring S, Weinshilboum R, Rodriguez SB, Kirchhoff C, Visscher T, Vuckovic A, Fialkowski A, McCarthy S, Malhotra D, Sebat J, Goff DC, Hudson JI, Lupski JR, Coyle JT, Rudolph U, Levy DL. Targeted Treatment of Individuals With Psychosis Carrying a Copy Number Variant Containing a Genomic Triplication of the Glycine Decarboxylase Gene. Biol Psychiatry. 2019 Oct 1;86(7):523-535. doi: 10.1016/j.biopsych.2019.04.031. Epub 2019 May 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of d-cycloserine (DCS) as an augmentation strategy in two psychotic patients with a triplication (4 copies) of the glycine decarboxylase (GLDC) gene. Subjects will first undergo an eight-week open-label arm of treatment with DCS (50 mg/d) followed by six 6-week double-blind placebo-controlled exposures to DCS or placebo. The length of each double-blind arm is limited to six weeks to minimize the length of symptom exacerbation experienced by the subjects when they are receiving placebo. The randomization scheme will allow two consecutive exposures to DCS, but will not allow two consecutive exposures to placebo, again to minimize the length of any symptom exacerbation. At the end of the open-label DCS trial, the following procedures will be carried out: structural MRI (3T), proton 1H MRS (4T), fMRI (3T), steady-state auditory evoked potentials, and electroretinogram recordings. In addition, 1H MRS (4T) for 2 hours after a single oral dose of a DCS will be assessed. Baseline data on all of these measures were previously obtained as part of a different study registered in clinical trials.gov - NCT01720316). Positive, negative, and affective symptoms and neurocognitive function as well as plasma levels of large neutral and large and small neutral and excitatory amino acids and psychotropic drug levels will be assessed periodically. Pharmaceutical grade DCS) or placebo will be compounded and dispensed by the McLean Hospital Pharmacy.\n\nThe investigators hypothesize that mutation carriers will have reduced endogenous brain glycine and GABA levels and increased brain glutamate and glutamine levels. DCS administration will increase brain glycine in the two carriers compared to baseline and treatment with glycine (0.8g/kg).\n\nThe investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs modulated by NMDA in mutation carriers compared with non-carrier family members and controls.\n\n. The investigators hypothesize that DCS, but not placebo, will improve positive, negative and affective symptoms as well as neurocognitive function.\n\nThe investigators also hypothesize that DCS will improve clinical and cognitive functioning, will partially normalize decreased baseline glycine and GABA and increased glutamate and glutamine, and will partially normalize magnocellular pathway activation and abnormal evoked potentials.', 'detailedDescription': 'Multiple rare structural variants of relatively recent evolutionary origin are recognized as important risk factors for schizophrenia (SZ) and other neurodevelopmental disorders (e.g., autism spectrum disorders, mental retardation, epilepsy) with odds ratios as high as 7-30. We have found a de novo structural rearrangement on chromosome 9p24.1 in two psychotic patients. One of the genes in this region is the gene encoding glycine decarboxylase (GLDC), which affects brain glycine metabolism. GLDC encodes the glycine decarboxylase or glycine cleavage system P-protein, which is involved in degradation of glycine in glia cells. Carriers of the GLDC triplication would be expected to have low levels of brain Gly, resulting in NMDA receptor-mediated hypofunction, which has been strongly implicated in the pathophysiology of schizophrenia.\n\nThere is an extensive literature on the effects of NMDA enhancing agents on positive, negative, and depressive symptoms and on neurocognitive function. Although many studies have reported positive results in at least one symptom domain, the results of other studies have been negative or ambiguous. Factors likely to contribute to this variability include: mechanism of action of the agent, compliance, concurrent treatment with first- vs second generation antipsychotic drugs, baseline glycine blood levels, presence/absence of kynurenine pathway metabolic abnormalities and individual differences in brain glycine uptake and metabolism . Genetic variants that impact the synthesis and breakdown of glycine, glutamate, or other modulators of NMDA receptor function are also likely to have significant effects. Although DCS augmentation has shown variable efficacy in patients unselected for having a mutation that would be expected to lower brain glycine levels, the GLDC triplication in the two carriers in this study would be expected to result in unusually low brain glycine levels, supporting its therapeutic potential as an augmentation strategy.\n\nThus, it is important to evaluate the therapeutic efficacy of DCS augmentation in individuals in whom there is a high prior probability of therapeutic benefit and to characterize the neurobiology of this mutation in terms of brain metabolites, brain function, and the pharmacokinetics of glycine metabolism using well-established methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '34 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Carriers of a triplication in the glycine decarboxylase gene\n\nExclusion Criteria:\n\n* Not carriers of a triplication in the glycine decarboxylase gene'}, 'identificationModule': {'nctId': 'NCT02304432', 'acronym': 'DCS', 'briefTitle': 'Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine', 'organization': {'class': 'OTHER', 'fullName': 'Mclean Hospital'}, 'officialTitle': 'Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine', 'orgStudyIdInfo': {'id': '1R21MH105732', 'link': 'https://reporter.nih.gov/quickSearch/1R21MH105732', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open label DCS', 'description': 'Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule for 8 weeks.', 'interventionNames': ['Drug: D-cycloserine']}, {'type': 'EXPERIMENTAL', 'label': 'DCS or placebo', 'description': 'Randomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.', 'interventionNames': ['Drug: D-cycloserine', 'Drug: DCS or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Second open label DCS', 'description': 'Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule for 24 weeks.', 'interventionNames': ['Drug: D-cycloserine']}], 'interventions': [{'name': 'D-cycloserine', 'type': 'DRUG', 'otherNames': ['Seromycin (d-cycloserine)'], 'description': 'Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.', 'armGroupLabels': ['DCS or placebo', 'Open label DCS']}, {'name': 'DCS or placebo', 'type': 'DRUG', 'otherNames': ['Seromycin (d-cycloserine) or placebo'], 'description': 'Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks.', 'armGroupLabels': ['DCS or placebo']}, {'name': 'D-cycloserine', 'type': 'DRUG', 'otherNames': ['Seromycin (d-cycloserine)'], 'description': 'Both participants received second open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.', 'armGroupLabels': ['Second open label DCS']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Deborah L. Levy, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mclean Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Minnesota', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Psychology Research Laboratory', 'investigatorFullName': 'Deborah L. Levy', 'investigatorAffiliation': 'Mclean Hospital'}}}}