Ketamine-enhanced Prolonged Exposure Therapy in PTSD

Phase 2

Recruiting

• Conditions: PTSD
• Interventions: Drug: Ketamine; Drug: Midazolam

• Registration Number: NCT04560660
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2021-03-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine and prolonged exposure (PE)	Ketamine	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.
Midazolam and prolonged exposure (PE)	Midazolam	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.

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	CAPS-5 to measure change in PTSD symptoms from baseline to post-treatment (10 weeks)	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.

Trial Locations

Locations (1)

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States