Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-05 @ 5:30 PM
Study NCT ID:
NCT01847469
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078305', 'term': 'Zonisamide'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ismene.petrakis@yale.edu', 'phone': '(203) 932-5711', 'title': 'Dr. Ismene Petrakis', 'organization': 'Yale University School of Medicine, VA Connecticut Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Adverse events were collected with a weekly questionnaire of side effects over the 12 week period.', 'eventGroups': [{'id': 'EG000', 'title': 'Zonisamide', 'description': 'Participants in this arm will receive zonisamide for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nZonisamide', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive placebo medication for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nPlacebo', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Difficulty Sleeping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressed Mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Memory Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicidal Ideation', 'notes': 'Patient hospitalized due to intoxication and suicidal ideation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'notes': 'Patient taken to emergency care following a fall.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'Participants in this arm will receive zonisamide for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nZonisamide'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive placebo medication for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nPlacebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '46.87', 'spread': '5.63', 'groupId': 'OG000'}, {'value': '51.00', 'spread': '9.48', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '7.44', 'spread': '5.47', 'groupId': 'OG000'}, {'value': '17.33', 'spread': '9.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Using a 90 day Timeline Follow Back (TLFB), the total number of drinking days at baseline and at 12 weeks of treatment were used.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population was used in the analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Heavy Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'Participants in this arm will receive zonisamide for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nZonisamide'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive placebo medication for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nPlacebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '43.94', 'spread': '5.37', 'groupId': 'OG000'}, {'value': '31.50', 'spread': '9.05', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '5.50', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '9.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Timeline Follow Back (TLFB) will be used to document the number of "heavy" drinking days during 12 weeks of treatment. Heavy drinking is defined as greater than or equal to 5 drinks for men and greater than or equal to 4 drinks for women.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population was used in the analysis.'}, {'type': 'PRIMARY', 'title': 'Clinician-Administered PTSD Scale (CAPS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'Participants in this arm will receive zonisamide for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nZonisamide'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive placebo medication for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nPlacebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '67.33', 'spread': '5.49', 'groupId': 'OG000'}, {'value': '72.83', 'spread': '9.51', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '30.83', 'spread': '6.02', 'groupId': 'OG000'}, {'value': '23.80', 'spread': '11.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Clinician-Administered PTSD Scale (CAPS) Total Score will be used to measure PTSD symptoms at the end of the 12 week intervention. The CAPS Total Score is a summing of the 17 items that are each scored 0-4- where 0 indicates "none". The range of Total Scores can be 0 to 136, where 136 would be the highest amount of scored PTSD symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population was used in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zonisamide', 'description': 'Participants in this arm will receive zonisamide for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nZonisamide'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive placebo medication for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zonisamide', 'description': 'Participants in this arm will receive zonisamide for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nZonisamide'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants in this arm will receive placebo medication for 12 weeks.\n\nEnhanced-Cognitive Processing Therapy-C (E-CPT-C)\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.28', 'spread': '12.94', 'groupId': 'BG000'}, {'value': '47.83', 'spread': '11.57', 'groupId': 'BG001'}, {'value': '45.17', 'spread': '12.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-24', 'size': 671605, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-18T13:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2013-01-23', 'resultsFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-02', 'studyFirstPostDateStruct': {'date': '2013-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Drinking Days', 'timeFrame': '12 weeks', 'description': 'Using a 90 day Timeline Follow Back (TLFB), the total number of drinking days at baseline and at 12 weeks of treatment were used.'}, {'measure': 'Number of Heavy Drinking Days', 'timeFrame': '12 weeks', 'description': 'Timeline Follow Back (TLFB) will be used to document the number of "heavy" drinking days during 12 weeks of treatment. Heavy drinking is defined as greater than or equal to 5 drinks for men and greater than or equal to 4 drinks for women.'}, {'measure': 'Clinician-Administered PTSD Scale (CAPS) Total Score', 'timeFrame': '12 weeks', 'description': 'The Clinician-Administered PTSD Scale (CAPS) Total Score will be used to measure PTSD symptoms at the end of the 12 week intervention. The CAPS Total Score is a summing of the 17 items that are each scored 0-4- where 0 indicates "none". The range of Total Scores can be 0 to 136, where 136 would be the highest amount of scored PTSD symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alcohol Dependence', 'Post-Traumatic Stress Disorder (PTSD)', 'Zonisamide', 'Cognitive Processing Therapy (CPT)'], 'conditions': ['Alcohol Dependence', 'Post-Traumatic Stress Disorder (PTSD)']}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization will be done using 3:1 ratio and will be performed by our research pharmacy using a random assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo. Medication will be titrated over a 6 week titration phase followed by a 6 week treatment phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will be provided by trained and qualified clinicians with extensive experience providing E-CPT-C. Veterans will be recruited primarily through advertisement, but also through the clinical facilities at the VA and from other collaborators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current alcohol dependence, as determined by a structured clinical interview (Structured Clinical Interview for DSM-IV Axis I Disorders) (SCID)\n* Current PTSD as determined by a structured clinical interview (SCID)\n* Veterans with current alcohol dependence, with at least one recent episode of heavy drinking over the past 14 days.\n* Medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories\n* For women, negative pregnancy test and use of acceptable method of contraception\n\nExclusion Criteria:\n\n* Females who are pregnant or lactating.\n* Veterans with a current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology, which in the opinion of the physician would preclude the subject from fully cooperating or be of potential harm during the course of the study\n* Veterans who meet current SCID criteria for a major Axis I diagnosis (Bipolar Disorders, Schizophrenia and Schizophrenia-type Disorders).\n* History of substance dependence (other than alcohol, tobacco or cannabis) by DSM-IV criteria in the last 90 days.\n* Veterans taking mood stabilizers and antipsychotic medications for specific psychiatric disorders.\n* Veterans with a history of allergy to zonisamide.\n* Veterans already receiving CPT.'}, 'identificationModule': {'nctId': 'NCT01847469', 'briefTitle': 'Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Zonisamide in Addition to Enhanced Cognitive Processing Therapy-C (E-CPT-C) for Veterans With PTSD and Comorbid Alcohol Dependence', 'orgStudyIdInfo': {'id': '1211011063'}, 'secondaryIdInfos': [{'id': '01641', 'type': 'OTHER', 'domain': 'VA IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zonisamide', 'description': 'Participants in this arm will receive zonisamide for 12 weeks.', 'interventionNames': ['Behavioral: Enhanced-Cognitive Processing Therapy-C (E-CPT-C)', 'Drug: Zonisamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this arm will receive placebo medication for 12 weeks.', 'interventionNames': ['Behavioral: Enhanced-Cognitive Processing Therapy-C (E-CPT-C)', 'Drug: Placebo']}], 'interventions': [{'name': 'Enhanced-Cognitive Processing Therapy-C (E-CPT-C)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Placebo', 'Zonisamide']}, {'name': 'Zonisamide', 'type': 'DRUG', 'otherNames': ['Zonegran'], 'armGroupLabels': ['Zonisamide']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healthcare System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Ismene Petrakis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ismene Petrakis', 'investigatorAffiliation': 'Yale University'}}}}