Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Repeated Ketamine Treatment to Accelerate Efficacy of Prolonged Exposure in PTSD

ID
Name
MHBP-006-19F
Description
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.
Trial arms
Trial start
2021-03-09
Estimated PCD
2024-12-01
Trial end
2025-10-31
Status
Recruiting
Phase
Early phase I
Treatment
Ketamine
FDA approved anesthetic medication with rapid acting antidepressant effects.
Arms:
Ketamine and prolonged exposure (PE)
Midazolam
FDA approved sedative medication with dissociative effects.
Arms:
Midazolam and prolonged exposure (PE)
Size
100
Primary endpoint
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
CAPS-5 to measure change in PTSD symptoms from baseline to post-treatment (10 weeks)
Eligibility criteria
Inclusion Criteria: * male or female Veterans between the ages of 18 and 75 years * diagnosis of PTSD * ability to provide written informed consent Exclusion Criteria: * females who are currently pregnant or breastfeeding * current high risk for suicide * history of moderate/severe head injury * history of psychosis * current episode of mania/hypomania * severe substance and/or alcohol use disorder in the last 6 months
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-05-17

1 organization

1 product

1 drug

1 indication

Organization
VA Office of Research and Development
Drug
Ketamine
Indication
PTSD
Product
Midazolam