Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 1:38 AM
Study NCT ID:
NCT04560660
Status:
COMPLETED
Last Update Posted:
2025-10-10
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine-enhanced Prolonged Exposure Therapy in PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D007649', 'term': 'Ketamine'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-09', 'size': 356620, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-22T17:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigators will use a sequentially numbered, opaque, sealed envelopes, pharmacy-controlled allocations, and coded identical containers for adequate concealment allocation. Administration of study drugs and infusion monitoring will be conducted by research nurse keeping blinding from investigators and independent outcome assessors.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomly assigned to one of two parallel treatment conditions: 1) adjunctive ketamine infusions to prolonged exposure therapy or 2) adjunctive midazolam (active placebo) infusions to prolonged exposure therapy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2020-09-17', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)', 'timeFrame': 'CAPS-5 to measure change in PTSD symptoms from baseline to post-treatment (10 weeks)', 'description': 'The CAPS-5 is the gold standard in PTSD assessment consisting of a a 30-item structured interview. The CAPS-5 will be recorded and aggregated from all study participants. Range from 0 to 80 with higher score denoting more severe PTSD symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-traumatic Stress Disorder'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo to reduce symptoms of Posttraumatic Stress Disorder (PTSD) among Veteran receiving Prolonged Exposure Therapy.', 'detailedDescription': 'In this single site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine in conjunction with prolonged exposure (PE) therapy for PTSD. Veterans who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of two treatment arms (placebo plus PE vs ketamine plus PE). Participants receive the study drug via intravenous infusion once per week for 3-weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female Veterans between the ages of 18 and 75 years\n* diagnosis of PTSD\n* ability to provide written informed consent\n\nExclusion Criteria:\n\n* females who are currently pregnant or breastfeeding\n* current high risk for suicide\n* history of moderate/severe head injury\n* history of psychosis\n* current episode of mania/hypomania\n* severe substance and/or alcohol use disorder in the last 6 months'}, 'identificationModule': {'nctId': 'NCT04560660', 'briefTitle': 'Ketamine-enhanced Prolonged Exposure Therapy in PTSD', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Repeated Ketamine Treatment to Accelerate Efficacy of Prolonged Exposure in PTSD', 'orgStudyIdInfo': {'id': 'MHBP-006-19F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine and prolonged exposure (PE)', 'description': 'Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Midazolam and prolonged exposure (PE)', 'description': 'Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'FDA approved anesthetic medication with rapid acting antidepressant effects.', 'armGroupLabels': ['Ketamine and prolonged exposure (PE)']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'FDA approved sedative medication with dissociative effects.', 'armGroupLabels': ['Midazolam and prolonged exposure (PE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417-2309', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Health Care System, Minneapolis, MN', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Paulo R Shiroma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis VA Health Care System, Minneapolis, MN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}