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NCT04889664 · ClinicalTrials.gov registry record · Phase 2
Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD
A Phase 2 study of PTSD, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT04889664: Completed Phase 2 study of PTSD, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04889664 is a Phase 2 study of PTSD that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 16 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04889664, a Phase 2 study of PTSD, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Clinician Administered PTSD Scale for DSM-5 (CAPS-5), assessed at baseline (before the first infusion) and 12 weeks following the start of WET. The Clinician-Administered PTSD Scale (CAPS) is a 30-item structured diagnostic interview designed to measure frequency and intensity of PTSD symptoms. The symptoms are scored in a 0-4 Likert-type scale, total score ranging from 0 to 80, higher score indicates more symptoms
Conditions Studied
Interventions
- DRUG Ketamine
- BEHAVIORAL Written Exposure Therapy
Study Locations (1)
New York
- Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai - Manhattan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-06-04 |
| Est. Completion | 2023-10-14 |
| Phase | Phase 2 |
What the finished NCT04889664 record still lists
NCT04889664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (95% lower).
The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Ketamine is the first listed.
NCT04889664 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04889664 about?
NCT04889664 is a clinical study titled "Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD". 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 th...
What is the current status of trial NCT04889664?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2021-06-04. Estimated completion is 2023-10-14.
What conditions does trial NCT04889664 study?
This clinical trial studies the following conditions: PTSD.
What interventions are being tested in trial NCT04889664?
The interventions under investigation include: Ketamine (DRUG), Written Exposure Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04889664?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04889664 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PTSD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04889664's enrollment target sits among peer trials
16 146th of 154 higher than 9 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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