Ketamine-enhanced Prolonged Exposure Therapy in PTSD

VA Office of Research and Development

Status and phase: Completed; Phase 2

Conditions: PTSD

Treatments: Drug: Midazolam; Drug: Ketamine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04560660

MHBP-006-19F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups, including a placebo group

Ketamine and prolonged exposure (PE)

Experimental group

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.

Treatment:

Drug: Ketamine

Midazolam and prolonged exposure (PE)

Placebo Comparator group

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.

Treatment:

Drug: Midazolam