Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-29 @ 6:57 PM
Study NCT ID:
NCT02376257
Status:
COMPLETED
Last Update Posted:
2018-09-19
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Therapeutic Learning in Depression: Proof of Concept
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003523', 'term': 'Cycloserine'}, {'id': 'D000077408', 'term': 'Modafinil'}], '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'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mwotto@bu.edu', 'phone': '617-353-9610', 'title': 'Michael Otto, PhD', 'organization': 'Boston UCRC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events for the visits on which study drugs were administered were assessed at the end of that session and (retrospectively) one week later for events occurring within several hours after that session (at Weeks 2 and 3, and retrospectively at 4). Serious adverse events were reported for the 4-week trial period as a whole.', 'description': 'Adverse events were assessed by open query', 'eventGroups': [{'id': 'EG000', 'title': '250 mg DCS', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n250 mg DCS: Drug', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '100 mg Modafinil', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n100 mg Modafinil: Drug', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\nPlacebo: Drug', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 7, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increased Energy/Concentration', 'notes': 'Mild levels of symptoms reported with no distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue/Low Motivation', 'notes': 'Mild levels of symptoms were reported with no distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recall of Cognitive Therapy Content', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg DCS', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n250 mg DCS: Drug'}, {'id': 'OG001', 'title': '100 mg Modafinil', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n100 mg Modafinil: Drug'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\nPlacebo: Drug'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '25.4', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '26.8', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '24.7', 'spread': '4.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '28.2', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '29.7', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '28.7', 'spread': '5.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2 and Week 3', 'description': 'A modified Cognitive Therapy Awareness Scale (CTAS) was used to assess delayed memory for cognitive therapy content from the computerized CBT. Higher scores indicate better memory for CBT skills. Scores range from 0 to 40.', 'unitOfMeasure': 'Number of correct units of information', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was missing for two participants.'}, {'type': 'PRIMARY', 'title': '1 Week Delayed Recall of Emotional Story Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg DCS', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n250 mg DCS: Drug'}, {'id': 'OG001', 'title': '100 mg Modafinil', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n100 mg Modafinil: Drug'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\nPlacebo: Drug'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '13.5', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '8.0', 'groupId': 'OG001'}, {'value': '16.1', 'spread': '9.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '25.0', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '26.4', 'spread': '11.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2 and Week 3', 'description': '1 Week Delayed Recall of a Threat-Related Story. Scores can range from 0 to 74, with higher scores reflect greater memory for story items.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '1 Week Delayed Recall Logical Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg DCS', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n250 mg DCS: Drug'}, {'id': 'OG001', 'title': '100 mg Modafinil', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n100 mg Modafinil: Drug'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\nPlacebo: Drug'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '3.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '9.5', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '13.6', 'spread': '5.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2 and Week 3', 'description': 'Higher scores reflect greater recall of Wechsler Memory Scale (WMS) Story B content assessed one week after last rehearsal. Possible scores range from 0 to 25.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Logical Memory Immediate Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg DCS', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n250 mg DCS: Drug'}, {'id': 'OG001', 'title': '100 mg Modafinil', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n100 mg Modafinil: Drug'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\nPlacebo: Drug'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '14.8', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '16.2', 'spread': '4.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '17.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '2.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '18.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '21.2', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'Immediate Story Recall from the Wechsler Memory Scale Story B. Higher scores reflect greater recall of the story material from the previous week. Possible scores range from 0 to 25.', 'unitOfMeasure': 'Number of story units recalled', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immediate Memory Measured by the Hopkins Verbal Learning Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg DCS', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n250 mg DCS: Drug'}, {'id': 'OG001', 'title': '100 mg Modafinil', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n100 mg Modafinil: Drug'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\nPlacebo: Drug'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '7.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': "The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The patient's free recall of the list is recorded. The same procedure is repeated for two more trials. The total recall score for the third trial was used as the recorded score and ranged from a minimum of zero to a maximum of 12 correct answers.", 'unitOfMeasure': 'Number of words recalled', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is missing for two participants.'}, {'type': 'SECONDARY', 'title': 'Immediate Recall of Emotional Story Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg DCS', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n250 mg DCS: Drug'}, {'id': 'OG001', 'title': '100 mg Modafinil', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n100 mg Modafinil: Drug'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\nPlacebo: Drug'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '22.4', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '35.2', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '32.2', 'spread': '13.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '34.4', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '46.8', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '35.5', 'spread': '11.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '38.4', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '49.9', 'spread': '12.4', 'groupId': 'OG001'}, {'value': '43.4', 'spread': '11.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'Immediate recall score of items from the Emotional Story presentation. Scores can range from 0 to 74, with higher scores reflect greater memory for story items.', 'unitOfMeasure': 'Number of story units recalled', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skills of Cognitive Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg DCS', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n250 mg DCS: Drug'}, {'id': 'OG001', 'title': '100 mg Modafinil', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n100 mg Modafinil: Drug'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\nPlacebo: Drug'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '23.3', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '24.8', 'spread': '5.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '26.4', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '25.7', 'spread': '4.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2 and Week 3', 'description': 'This measure assesses the self-reported use of skills from cognitive therapy. Scores can range from 8 to 40, and higher scores indicate greater use.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is missing for one participant.'}, {'type': 'SECONDARY', 'title': 'Digits Backward', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg DCS', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n250 mg DCS: Drug'}, {'id': 'OG001', 'title': '100 mg Modafinil', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n100 mg Modafinil: Drug'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\nPlacebo: Drug'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.3', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '11.3', 'spread': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '9.25', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '10.0', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '12.1', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '9.6', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '11.7', 'spread': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'The examiner reads a list of digits and asks that each digit be read backwards. The score is the total number of trials completed correctly; scores range from 0 to 16. Higher scores indicate better performance.', 'unitOfMeasure': 'Number of correct trials', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is missing for two participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '250 mg DCS', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n250 mg DCS: Drug'}, {'id': 'FG001', 'title': '100 mg Modafinil', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\n100 mg Modafinil: Drug'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Randomized drug intervention was administered on two weekly sessions following baseline evaluation\n\nPlacebo: Drug'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '250 mg DCS', 'description': 'Baseline assessment (week 1), two weekly sessions when 250mg DCS is administered, and final week (week 4) when retention is assessed.\n\n250 mg DCS: Drug'}, {'id': 'BG001', 'title': '100 mg Modafinil', 'description': 'Baseline assessment (week 1), two weekly sessions when 100 mg modafinil is administered, and final week (week 4) when retention is assessed.\n\n100 mg Modafinil: Drug'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Baseline assessment (week 1), two weekly sessions when placebo is administered, and final week (week 4) when retention is assessed.\n\nPlacebo: Drug'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '34.9', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '26.4', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '27.7', 'spread': '10.8', 'groupId': 'BG002'}, {'value': '29.9', 'spread': '11.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Transgender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Immediate Memory measured by the Hopkins Verbal Learning Task', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '9.6', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '9.6', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '9.2', 'spread': '1.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The patient's free recall of the list is recorded. The same procedure is repeated for two more trials. The total recall score for the last trial was used as the baseline score and ranged from a minimum of zero to a maximum of 12 correct answers.", 'unitOfMeasure': 'number of correctly recalled words', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were obtained on 34 of the 36 participants.'}, {'title': 'Digits backwards', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '9.5', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '11.3', 'spread': '2.5', 'groupId': 'BG002'}, {'value': '9.6', 'spread': '2.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The examiner reads a list of digits and asks that each digit be read backwards. After correct scores, longer lists of digits are then provided. The total number of correct trials is recorded with higher scores indicating better performance. Scores can range from 0 to 16.', 'unitOfMeasure': 'Number of correct trials', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were obtained for 33 of the 36 participants.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-11-15', 'size': 270728, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-07T09:32', 'hasProtocol': True}, {'date': '2013-11-15', 'size': 227159, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-07T09:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2014-07-11', 'resultsFirstSubmitDate': '2018-05-20', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-22', 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recall of Cognitive Therapy Content', 'timeFrame': 'Week 2 and Week 3', 'description': 'A modified Cognitive Therapy Awareness Scale (CTAS) was used to assess delayed memory for cognitive therapy content from the computerized CBT. Higher scores indicate better memory for CBT skills. Scores range from 0 to 40.'}, {'measure': '1 Week Delayed Recall of Emotional Story Items', 'timeFrame': 'Week 2 and Week 3', 'description': '1 Week Delayed Recall of a Threat-Related Story. Scores can range from 0 to 74, with higher scores reflect greater memory for story items.'}, {'measure': '1 Week Delayed Recall Logical Memory', 'timeFrame': 'Week 2 and Week 3', 'description': 'Higher scores reflect greater recall of Wechsler Memory Scale (WMS) Story B content assessed one week after last rehearsal. Possible scores range from 0 to 25.'}], 'secondaryOutcomes': [{'measure': 'Logical Memory Immediate Recall', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'Immediate Story Recall from the Wechsler Memory Scale Story B. Higher scores reflect greater recall of the story material from the previous week. Possible scores range from 0 to 25.'}, {'measure': 'Immediate Memory Measured by the Hopkins Verbal Learning Task', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': "The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The patient's free recall of the list is recorded. The same procedure is repeated for two more trials. The total recall score for the third trial was used as the recorded score and ranged from a minimum of zero to a maximum of 12 correct answers."}, {'measure': 'Immediate Recall of Emotional Story Items', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': 'Immediate recall score of items from the Emotional Story presentation. Scores can range from 0 to 74, with higher scores reflect greater memory for story items.'}, {'measure': 'Skills of Cognitive Therapy', 'timeFrame': 'Week 2 and Week 3', 'description': 'This measure assesses the self-reported use of skills from cognitive therapy. Scores can range from 8 to 40, and higher scores indicate greater use.'}, {'measure': 'Digits Backward', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'The examiner reads a list of digits and asks that each digit be read backwards. The score is the total number of trials completed correctly; scores range from 0 to 16. Higher scores indicate better performance.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive behavior therapy (CBT)', 'd-cycloserine (DCS)', 'Modafinil'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '27094721', 'type': 'BACKGROUND', 'citation': 'Otto MW, Lee J, Hofmann SG, Hearon BA, Smits JA, Rosenfield D, Fava M, Wright JH. Examining the efficacy of d-cycloserine to augment therapeutic learning in depression. Contemp Clin Trials. 2016 May;48:146-52. doi: 10.1016/j.cct.2016.03.009. Epub 2016 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'Despite advances in both pharmacotherapy and psychotherapy for major depression, non-response and partial-response remain relatively common outcomes, motivating the search for new treatments. This study is concerned with the development of one such novel treatment, the augmentation of exposure-based cognitive-behavior therapy (CBT) with d-cycloserine (DCS).', 'detailedDescription': 'Investigators will study the efficacy of DCS for augmenting therapeutic learning relevant for the treatment of depression (i.e., outside the extinction learning where DCS has been shown to have success). Specifically, the study investigates the role of DCS in enhancing declarative memory in depressed individuals, as evaluated by standardized tests and the retention of cognitive therapy session material. Investigators will also study an active comparison agent, modafinil, which appears to offer cognitive enhancing effects among both sleep-deprived and non-sleep-deprived individuals, but also appears to have drug-state (e.g., mood and side) effects that are not characteristic of DCS augmentation. Therefore, drug-context effects may affect memory retention over time. Hence, the study will evaluate memory enhancement effects both during the period of drug action as well as one week later when no drug is taken. Overall, investigators will examine cognitive function and memory performance over 4 study sessions in 96 men and women with major depression, who, in a double-blind fashion, will be randomly assigned to either: (1) 250mg DCS, (2) 100mg modafinil, or (3) placebo administered on Study Weeks 2 and 3. The memory tests include both items unique to a given study week and memory tasks that are repeated over time that allow assessment of memory and retention effects across one-week periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a DSM diagnosis of major depression as determined by structured diagnostic interview\n* Must be free of psychotropic medications other than serotonin selective reuptake inhibitors (SSRIs) for at least 2 weeks\n* No current suicidal ideation\n* Able to speak and understand English\n* Must be between the ages of 18 and 65, inclusive\n* Must be a male, or a female who is not of childbearing potential (i.e., surgically sterile, postmenopausal for at least 1 year) or who is non-pregnant, non-lactating and using a medically accepted method of contraception. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, hormonal contraceptives. A woman of childbearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the trial\n\nExclusion Criteria:\n\n* A DSM diagnosis of dementia, neurodegenerative disease, or other organic mental disorder; substance use disorder other than nicotine or caffeine in the last 3 months; bulimia or anorexia within the last 3 months; lifetime history of psychotic disorder or, bipolar disorder, or developmental disorder;\n* A diagnosis of organic brain syndrome, mental retardation, or other cognitive dysfunction that could interfere with a participants capacity to participate in CBT or to complete safety and efficacy assessments\n* A history of seizures (apart from childhood febrile seizures) or head trauma causing ongoing cognitive impairment\n* An uncontrolled, unstable clinically significant medical condition (e.g., renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy, or poorly controlled hypertension (\\> 150/90mmHg) that may interfere with the interpretation of safety and efficacy evaluations in the opinion of the study physician or investigator\n* Medical illness including hypertension, cardiac disease, liver disease, pulmonary diseases, central nervous system disease, and epilepsy;\n* Recent (1 year) suicidal attempts or current suicidal ideation\n* For women, currently pregnant, plans to be pregnant in the next 2 months, or currently breastfeeding\n* Treatment with phenytoin, isoniazid, or propranolol or known sensitivity to modafinil or cycloserine\n* A history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment\n* Use of psychotropic medication (including stimulants) other than SSRIs\n* Current daily use of alcohol or regular binge alcohol use as determined on the medical screen\n* Insufficient command of the English language (i.e., cannot carry on a conversation with an interviewer in the English language or read associated text)\n* Receipt of CBT in the previous five years'}, 'identificationModule': {'nctId': 'NCT02376257', 'briefTitle': 'Improving Therapeutic Learning in Depression: Proof of Concept', 'organization': {'class': 'OTHER', 'fullName': 'Boston University Charles River Campus'}, 'officialTitle': 'Improving Therapeutic Learning in Depression: Proof of Concept', 'orgStudyIdInfo': {'id': 'R21MH102646', 'link': 'https://reporter.nih.gov/quickSearch/R21MH102646', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '250 mg DCS', 'description': 'Baseline assessment (week 1), two weekly sessions when 250mg DCS is administered, and final week (week 4) when retention is assessed.', 'interventionNames': ['Drug: 250 mg DCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': '100 mg modafinil', 'description': 'Baseline assessment (week 1), two weekly sessions when 100 mg modafinil is administered, and final week (week 4) when retention is assessed.', 'interventionNames': ['Drug: 100 mg Modafinil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Baseline assessment (week 1), two weekly sessions when placebo is administered, and final week (week 4) when retention is assessed.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '250 mg DCS', 'type': 'DRUG', 'otherNames': ['d-cycloserine'], 'description': 'Drug', 'armGroupLabels': ['250 mg DCS']}, {'name': '100 mg Modafinil', 'type': 'DRUG', 'description': 'Drug', 'armGroupLabels': ['100 mg modafinil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Drug', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michael W Otto, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University Charles River Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Michael Otto', 'investigatorAffiliation': 'Boston University Charles River Campus'}}}}