MedTrace Logo

Ketamine-enhanced Prolonged Exposure Therapy in PTSD

NCT04560660 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-10-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ketamine

FDA approved anesthetic medication with rapid acting antidepressant effects.

DRUG

Midazolam

FDA approved sedative medication with dissociative effects.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Paulo R Shiroma, MD · Minneapolis VA Health Care System, Minneapolis, MN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2025-07-01
Completion
2025-10-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04560660 on ClinicalTrials.gov