NCT04560660 - Ketamine-enhanced Prolonged Exposure Therapy in PTSD | Crick

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

73

Conditions

PTSD

Interventions

KetamineDRUG

FDA approved anesthetic medication with rapid acting antidepressant effects.

MidazolamDRUG

FDA approved sedative medication with dissociative effects.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States