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Enhancing Week-long Psychological Treatment for PTSD With Ketamine

NCT05737693 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-05-07

No results posted yet for this study

Summary

The purpose of this study is to test if the combination of ketamine, vs midazolam, with an intensive trauma-focused psychotherapy will be more effective in relieving post-traumatic stress disorder (PTSD). This week-long treatment has the potential to produce a significant therapeutic effect that otherwise would take months to occur. The study will also focus on learning about the neurophysiological changes produced by the proposed clinical trial.

Conditions

Interventions

DRUG

Ketamine

Week-long exposure therapy with ketamine infusion on day 2 and 4 of the psychotherapy

DRUG

Midazolam

Week-long exposure therapy with midazolam infusion on day 2 and 4 of the psychotherapy

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Ilan Harpaz-Rotem, PhD ABPP · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2030-08-01
Completion
2031-08-01
FDA Drug
Yes

Countries

  • United States
  • Israel

Study Locations

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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 NCT05737693 on ClinicalTrials.gov