CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04889664
NCT04889664Phase 2Completed

Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD: A Pilot Study

Icahn School of Medicine at Mount Sinai·interventional·Posted May 17, 2021·Updated Oct 8, 2024

In Brief

A Phase 2 clinical trial evaluating Ketamine and Written Exposure Therapy for PTSD. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The current pilot project will evaluate the efficacy of adding Written Exposure Therapy (WET) to a course of repeated IV ketamine infusions in improving PTSD symptoms and maintaining symptom improvement in patients with chronic PTSD. WET is a brief, 5-session evidence-based written trauma-focused therapy without in between-session assignments, with demonstrated efficacy and low dropout rates in patients with PTSD. WET will be administered to all eligible participants; the first WET sessions will be interleaved with the last two ketamine infusions to take advantage of a window of increased neuroplasticity potentially induced by repeated ketamine infusions. WET will be administered on different days as the ketamine infusions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedMay 17, 2021
Enrollment StartJun 4, 2021
Primary CompletionOct 14, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.1 years ago

Interventions

Ketaminedrug

Repeated intravenous Ketamine infusions.

Written Exposure Therapybehavioral

WET is a brief, 5-session evidence-based written trauma-focused therapy