Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
Study NCT ID:
NCT02066792
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2014-02-17
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dose Timing of D-Cycloserine to Augment CBT for Social Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003523', 'term': 'Cycloserine'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], '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': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smits@utexas.edu', 'phone': '512-475-8095', 'title': 'Dr. Jasper Smits', 'organization': 'Institute for Mental Health Research and Department of Psychology, The University of Texas at Austin'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data for adverse events was collected at each assessment point over the course of the study (e.g., in-person screening, baseline appointment, sessions 1-5, and the 1-week, 1-month, and 3-month follow-ups).', 'description': 'Participants were asked if they had experienced any injuries or illnesses at the beginning of each study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Tailored Post-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). DCS will be administered if the session is deemed a success.\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pre-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session).\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session).\n\nPlacebo: Sugar pill', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Non-Tailored Post-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session).\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Serious Adverse Event', 'notes': 'Participant was hospitalized for an aborted suicide attempt during the follow-up phase of the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Social Anxiety Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Post-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). Individuals are administered dcs after the session if exposure is determined successful (SUDS below 40). Individuals are administered the placebo is exposure is determined unsuccessful.\n\nThe type of pill (i.e. dcs vs. placebo) administered after session is determined after the session.\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill'}, {'id': 'OG001', 'title': 'Pre-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session).\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session).\n\nPlacebo: Sugar pill'}, {'id': 'OG003', 'title': 'Non-Tailored Post-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session).\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill'}], 'classes': [{'categories': [{'measurements': [{'value': '-.46', 'spread': '.13', 'groupId': 'OG000'}, {'value': '-.90', 'spread': '.13', 'groupId': 'OG001'}, {'value': '-.39', 'spread': '.14', 'groupId': 'OG002'}, {'value': '-.88', 'spread': '.14', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.51', 'ciLowerLimit': '-.81', 'ciUpperLimit': '-.21', 'pValueComment': 'two-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.15', 'groupDescription': 'At 3 month follow-up', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.'}, {'pValue': '.635', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.07', 'ciLowerLimit': '-.37', 'ciUpperLimit': '.23', 'pValueComment': 'Two-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.15', 'groupDescription': '3 month follow-up', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.'}, {'pValue': '.002', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.49', 'ciLowerLimit': '-.80', 'ciUpperLimit': '-.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.16', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.'}, {'pValue': '.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.44', 'ciLowerLimit': '-.73', 'ciUpperLimit': '-.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.15', 'groupDescription': '3 month follow-up', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.'}, {'pValue': '.008', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.41', 'ciLowerLimit': '-.72', 'ciUpperLimit': '-.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.16', 'groupDescription': '3 month follow-up', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessments took place at multiple time points from baseline to 3-month follow-up. The three-month is reported', 'description': 'The main outcome was a composite Z-score from the Liebowitz Social Anxiety Scale (LSAS) and the Social Phobic Disorders Severity and Change Form (SPD-SC Form).\n\n"The Composite Z-score of the LSAS and SPD-SC Form indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population. Negative numbers indicate values lower symptom severity and positive numbers indicate higher symptom severity.\n\nThe LSAS is a 24-item scale that measures fear and avoidance in social and performance situations within the last week, using 0 (no fear/never avoids) to 3 (severe fear/usually avoids) scale. LSAS scores range from 0-144 with higher scores indicated worse outcomes. The SPD-S is the Clinical Global Impression Scale27 adapted for SAD, which instructs evaluators to use a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill patients) to index the severity of social anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tailored Post-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). Individuals are administered dcs after the session if exposure is determined successful (SUDS below 40). Individuals are administered the placebo is exposure is determined unsuccessful.\n\nThe type of pill (i.e. dcs vs. placebo) administered after session is determined after the session.\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill'}, {'id': 'FG001', 'title': 'Pre-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session).\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session).\n\nPlacebo: Sugar pill'}, {'id': 'FG003', 'title': 'Non-Tailored Post-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session).\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Tailored Post-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). DCS will be administered if the session is deemed a success.\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill'}, {'id': 'BG001', 'title': 'Pre-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session).\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session).\n\nPlacebo: Sugar pill'}, {'id': 'BG003', 'title': 'Non-Tailored Post-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session).\n\nD-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction.\n\nPlacebo: Sugar pill'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.78', 'spread': '9.88', 'groupId': 'BG000'}, {'value': '29.73', 'spread': '10.42', 'groupId': 'BG001'}, {'value': '28.76', 'spread': '11.81', 'groupId': 'BG002'}, {'value': '27.54', 'spread': '8.29', 'groupId': 'BG003'}, {'value': '29.20', 'spread': '10.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-02', 'size': 1539599, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-26T14:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2014-02-17', 'resultsFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-26', 'studyFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Anxiety Symptom Severity', 'timeFrame': 'Assessments took place at multiple time points from baseline to 3-month follow-up. The three-month is reported', 'description': 'The main outcome was a composite Z-score from the Liebowitz Social Anxiety Scale (LSAS) and the Social Phobic Disorders Severity and Change Form (SPD-SC Form).\n\n"The Composite Z-score of the LSAS and SPD-SC Form indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population. Negative numbers indicate values lower symptom severity and positive numbers indicate higher symptom severity.\n\nThe LSAS is a 24-item scale that measures fear and avoidance in social and performance situations within the last week, using 0 (no fear/never avoids) to 3 (severe fear/usually avoids) scale. LSAS scores range from 0-144 with higher scores indicated worse outcomes. The SPD-S is the Clinical Global Impression Scale27 adapted for SAD, which instructs evaluators to use a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill patients) to index the severity of social anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Social Phobia'], 'conditions': ['Social Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '37979218', 'type': 'DERIVED', 'citation': 'Taylor CT, Rosenfield D, Dowd SM, Dutcher CD, Hofmann SG, Otto MW, Pollack MH, Smits JAJ. What good are positive emotions for treatment? A replication test of whether trait positive emotionality predicts response to exposure therapy for social anxiety disorder. Behav Res Ther. 2023 Dec;171:104436. doi: 10.1016/j.brat.2023.104436. Epub 2023 Nov 11.'}, {'pmid': '37399757', 'type': 'DERIVED', 'citation': 'Lubin RE, Fitzgerald HE, Rosenfield D, Carpenter JK, Papini S, Dutcher CD, Dowd SM, Hofmann SG, Pollack MH, Smits JAJ, Otto MW. Using pre-treatment de novo threat conditioning outcomes to predict treatment response to DCS augmentation of exposure-based CBT. J Psychiatr Res. 2023 Aug;164:357-363. doi: 10.1016/j.jpsychires.2023.06.008. Epub 2023 Jun 19.'}, {'pmid': '34010494', 'type': 'DERIVED', 'citation': 'Dutcher CD, Dowd SM, Zalta AK, Taylor DJ, Rosenfield D, Perrone A, Otto MW, Pollack MH, Hofmann SG, Smits JAJ. Sleep quality and outcome of exposure therapy in adults with social anxiety disorder. Depress Anxiety. 2021 Nov;38(11):1182-1190. doi: 10.1002/da.23167. Epub 2021 May 19.'}, {'pmid': '32496566', 'type': 'DERIVED', 'citation': 'Smits JAJ, Pollack MH, Rosenfield D, Otto MW, Dowd S, Carpenter J, Dutcher CD, Lewis EM, Witcraft SM, Papini S, Curtiss J, Andrews L, Kind S, Conroy K, Hofmann SG. Dose Timing of D-Cycloserine to Augment Exposure Therapy for Social Anxiety Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e206777. doi: 10.1001/jamanetworkopen.2020.6777.'}, {'pmid': '31622374', 'type': 'DERIVED', 'citation': 'Hofmann SG, Papini S, Carpenter JK, Otto MW, Rosenfield D, Dutcher CD, Dowd S, Lewis M, Witcraft S, Pollack MH, Smits JAJ. Effect of d-cycloserine on fear extinction training in adults with social anxiety disorder. PLoS One. 2019 Oct 17;14(10):e0223729. doi: 10.1371/journal.pone.0223729. eCollection 2019.'}, {'pmid': '26111923', 'type': 'DERIVED', 'citation': 'Hofmann SG, Carpenter JK, Otto MW, Rosenfield D, Smits JA, Pollack MH. Dose timing of D-cycloserine to augment cognitive behavioral therapy for social anxiety: Study design and rationale. Contemp Clin Trials. 2015 Jul;43:223-30. doi: 10.1016/j.cct.2015.06.015. Epub 2015 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy of 50 mg of d-cycloserine in comparison to placebo (a pill containing no medication) for improving the effectiveness of cognitive-behavioral therapy (CBT) in reducing symptoms associated with social anxiety disorder. In addition, the study will examine whether the effectiveness of d-cycloserine depends on the timing of the pill administration (i.e., 1- hour before the session or immediately after the session) as well as the success of the CBT therapy sessions. The investigators hypothesize that the tailored post-session DCS administration condition will outperform the other conditions (pre-session DCS, placebo, and non-tailored post-session DCS). This will be evidenced by short- and long-term improvements in social anxiety severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female outpatients \\> 18 years of age with a primary psychiatric diagnosis (designated by the patient as the most important source of current distress) of social anxiety disorder as defined by DSM-5 criteria.\n* A total score \\> 60 on the LSAS.\n* Physical examination and laboratory findings without clinically significant abnormalities.\n* Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n* A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.\n* PTSD within the past 6 months. Entry of patients with other mood or anxiety disorders will be permitted if the SAD is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample. Patients with significant suicidal ideation (MADRS item 10 score \\> 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.\n* Patients must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.\n* Significant personality dysfunction likely to interfere with study participation.\n* Serious medical illness or instability for which hospitalization may be likely within the next year.\n* Patients with a current or past history of seizures.\n* Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).\n* Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the SAD is excluded. Prohibited psychotherapy includes CBT or psychodynamic therapy focusing on exploring specific, dynamic causes of the phobic symptomatology and providing management skills. General supportive therapy initiated \\> 3 months prior is acceptable.\n* Prior non-response to adequately-delivered exposure (i.e., as defined by the patient's report of receiving specific and regular exposure assignments as part of a previous treatment).\n* Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment. Current use of isoniazid or ethionamide compounds\n* Insufficient command of the English language"}, 'identificationModule': {'nctId': 'NCT02066792', 'briefTitle': 'Dose Timing of D-Cycloserine to Augment CBT for Social Anxiety Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Dose Timing of D-Cycloserine to Augment CBT for Social Anxiety Disorder', 'orgStudyIdInfo': {'id': 'R34MH099318', 'link': 'https://reporter.nih.gov/quickSearch/R34MH099318', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored Post-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). The type of pill (i.e. dcs vs. placebo) will be determined after the session.', 'interventionNames': ['Drug: D-Cycloserine', 'Drug: Placebo', 'Behavioral: Cognitive Behavioral Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pre-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session).', 'interventionNames': ['Drug: D-Cycloserine', 'Drug: Placebo', 'Behavioral: Cognitive Behavioral Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session).', 'interventionNames': ['Drug: Placebo', 'Behavioral: Cognitive Behavioral Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Tailored Post-Session DCS', 'description': 'Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session).', 'interventionNames': ['Drug: D-Cycloserine', 'Drug: Placebo', 'Behavioral: Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'D-Cycloserine', 'type': 'DRUG', 'otherNames': ['D-cycloserine, DCS'], 'description': 'D-cycloserine is a medication thought to be associated with fear extinction.', 'armGroupLabels': ['Non-Tailored Post-Session DCS', 'Pre-Session DCS', 'Tailored Post-Session DCS']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar pill', 'armGroupLabels': ['Non-Tailored Post-Session DCS', 'Placebo', 'Pre-Session DCS', 'Tailored Post-Session DCS']}, {'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'This will be a 5-session version of a group CBT protocol with 4-6 patients and 2 therapists per group emphasizing repeated exposure practices. Session 1 involves an introduction and orientation to the CBT model. Sessions 2-5 emphasize repeated exposure tasks, which consist of role-play activities to confront fearful situations in a group setting while disputing cognitive distortions (coupled with the fading of safety behaviors). At the conclusion of each exposure session, patients will be encouraged to continue to apply home-practice strategies (such as giving speeches in front of a mirror). Continued practice of the interventions will be considered part of treatment, and patients will be asked to refrain from alternative treatment for four weeks following completion of the last treatment session.', 'armGroupLabels': ['Non-Tailored Post-Session DCS', 'Placebo', 'Pre-Session DCS', 'Tailored Post-Session DCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Mark Pollack, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}, {'name': 'Stefan Hofmann, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}, {'name': 'Jasper A Smits, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rush University Medical Center', 'class': 'OTHER'}, {'name': 'Boston University', 'class': 'OTHER'}, {'name': 'Southern Methodist University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}