Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00632632
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2008-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Virtual Reality & D-cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental 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': 'jdifede@med.cornell.edu', 'phone': '212 746 3079', 'title': 'JoAn Difede, PhD', 'organization': 'Weill Cornell Medical College'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'D-Cycloserine (DCS)', 'description': 'D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinician Administered PTSD Scale(CAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-Cycloserine (DCS)', 'description': 'D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).'}], 'classes': [{'categories': [{'measurements': [{'value': '32.38', 'spread': '28.55', 'groupId': 'OG000'}, {'value': '42.17', 'spread': '20.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment', 'description': 'Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.\n\nSubscales:\n\nCAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-Cycloserine (DCS)', 'description': 'D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately following treatment', 'description': 'Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.', 'unitOfMeasure': 'percentage of MDD remission', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clinician Administered PTSD Scale(CAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-Cycloserine (DCS)', 'description': 'D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).'}], 'classes': [{'categories': [{'measurements': [{'value': '24.15', 'spread': '26.48', 'groupId': 'OG000'}, {'value': '45.92', 'spread': '25.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-months follow-up', 'description': 'Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.\n\nSubscales:\n\nCAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'D-Cycloserine (DCS)', 'description': 'D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'D-Cycloserine (DCS)', 'description': 'D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.77', 'spread': '11.92', 'groupId': 'BG000'}, {'value': '43.75', 'spread': '8.72', 'groupId': 'BG001'}, {'value': '45.84', 'spread': '10.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2008-02-29', 'resultsFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2008-03-10', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-29', 'studyFirstPostDateStruct': {'date': '2008-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Administered PTSD Scale(CAPS)', 'timeFrame': 'Immediately following treatment', 'description': 'Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.\n\nSubscales:\n\nCAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)'}, {'measure': 'Clinician Administered PTSD Scale(CAPS)', 'timeFrame': '6-months follow-up', 'description': 'Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.\n\nSubscales:\n\nCAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)'}], 'secondaryOutcomes': [{'measure': 'Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)', 'timeFrame': 'Immediately following treatment', 'description': 'Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['World Trade Center Victims', 'Iraq War Veterans', 'PTSD'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.patss.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study proposes to evaluate the effects of D-cycloserine (DCS) combined with Virtual Reality exposure therapy in a sample of patients who developed posttraumatic stress disorder (PTSD) following either the events of September 11, 2001, or military service in the war in Iraq. In addition, this study hopes to determine whether a common human genetic single nucleotide polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF (Val66Met), predicts treatment response to PTSD.\n\nOverall, this study aims 1) to determine if subjects administered DCS show a significantly larger decrease in symptoms of PTSD as compared to those administered a placebo, 2) to determine if subjects administered DCS show a decrease in PTSD symptomatology significantly earlier (as measured by weeks) than those administered a placebo, 3) to determine if differences in symptomatology are evident at a 6-month follow-up and indicate long-term differences between groups, and 4) to determine if the BDNF SNP predicts treatment response.', 'detailedDescription': 'Participants with 9/11-related or military service in the Iraq War-related PTSD are assigned to one of two programs, following an initial assessment. Both programs include Virtual Reality Exposure Therapy (VRET) for the treatment of PTSD as well as widely-used standard cognitive-behavioral therapy techniques. The VRET is comprised of ten ninety minute sessions which involve mental imagery as well as virtual reality presentations delivered by a special display worn over the head and eyes. The virtual reality simulations consist of either images of the World Trade Center and the events of September 11, 2001 or multiple scenarios common to military personnel assigned to Iraq. One group of participants will receive the medication cycloserine (seromycin) and one group will receive a placebo drug (like a sugar pill). Participants take a dose of medication only on the days that they come to the laboratory for the Virtual Reality Exposure (VRE) sessions, and 90 minutes prior to the VRE sessions. Some subjects in the study will receive a 100 mg dose of cycloserine, and other subjects in the study will receive the placebo (sugar pill). This will be determined randomly (as by the flip of a coin). Neither the patient nor the treating clinicians will know which pill that patients are receiving; however, this arrangement may be changed if medically necessary. Patients are briefly assessed for well-being at every session, and are reassessed following session three, session six, and session ten for changes in symptomatology. At the completion of treatment and again six months later, the principal investigator or one of her associates will reinterview participants and have them complete some questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English-speaking adults\n2. Between the ages of 18 and 70\n3. Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War\n4. Diagnosed with PTSD symptoms.\n\nExclusion Criteria:\n\n1. Presence of current organic mental disorder\n2. Schizophrenia\n3. Bipolar disorder\n4. Depression with psychotic features\n5. Current substance dependence\n6. Delusional disorder\n7. Active suicidal ideation, intent, or plan\n8. Active homicidal ideation, intent, or plan\n9. Use of pacemaker\n10. Medically unstable\n11. Pregnant or lactating\n12. A history of severe renal disease\n13. History of seizures\n14. Currently taking anticoagulants, ethionamide (Trecator-SC) or isoniazid (INH)\n15. History of allergic reaction to cycloserine.'}, 'identificationModule': {'nctId': 'NCT00632632', 'acronym': 'VR-DCS', 'briefTitle': 'Virtual Reality & D-cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)', 'nctIdAliases': ['NCT00161499'], 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Combined Exposure Therapy and D-Cycloserine vs. Placebo for Posttraumatic Stress Disorder', 'orgStudyIdInfo': {'id': '0411007625'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-Cycloserine (DCS)', 'interventionNames': ['Drug: D-Cycloserine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'D-Cycloserine', 'type': 'DRUG', 'description': 'Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality with D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)', 'armGroupLabels': ['D-Cycloserine (DCS)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (approximately 10-12 times).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'JoAnn Difede, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}