NCT04889664

Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD

Completed Phase 2 Results posted Last updated 8 October 2024

What this trial tests

Phase 2 trial testing Ketamine in PTSD in 16 participants. Completed in 14 October 2023.

Timeline

4 June 2021

Primary endpoint
14 October 2023

14 October 2023

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	4 June 2021
Primary completion	14 October 2023
Estimated completion	14 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Ketamine (ketamine) — full drug profile →
• Written Exposure Therapy

Conditions studied

• PTSD — all drugs for PTSD →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 18 to 70, any sex, with PTSD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CAPS-5 Primary · Baseline and Week 12

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

Baseline, the morning of first ketamine infusion

Group	Value	95% CI
Ketamine and Written Exposure Therapy	41.6	± 6.2

Week 12

Group	Value	95% CI
Ketamine and Written Exposure Therapy	20.8	± 14.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ketamine and Written Exposure Therapy

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (12 terms — click to expand)

Reaction	System	Ketamine and Written Expos…
Fatigue	General disorders	—
Other	General disorders	—
Headache	Nervous system disorders	—
Dizziness	Nervous system disorders	—
Blurred Vision	Nervous system disorders	—
Nausea/vomiting	Gastrointestinal disorders	—
Frequent Urination	Renal and urinary disorders	—
Difficulty Sleeping	General disorders	—
Menstrual Irregularity	Reproductive system and breast disorders	—
Increased Perspiration	Skin and subcutaneous tissue disorders	—
Decreased energy	General disorders	—
Anxiety	General disorders	—

Data from ClinicalTrials.gov NCT04889664 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
   Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418
2. Acute sleep interventions as an avenue for treatment of trauma-associated disorders.
   Swift KM, Thomas CL, Balkin TJ, Lowery-Gionta EG, et al · · 2022 · cited 16× · PMID 35678060 · DOI 10.5664/jcsm.10074
3. The potential of ketamine for posttraumatic stress disorder: a review of clinical evidence.
   Ragnhildstveit A, Roscoe J, Bass LC, Averill CL, et al · · 2023 · cited 13× · PMID 36895431 · DOI 10.1177/20451253231154125
4. Combining Ketamine Infusions and Written Exposure Therapy for Chronic PTSD: An Open-Label Trial.
   Feder A, Brown O, Rutter SB, Cahn L, et al · · 2025 · PMID 40215385 · DOI 10.4088/jcp.24m15622