Study Summary
This trial will test whether adding a brief, 5-session written trauma-focused therapy to a course of repeated IV ketamine infusions can prolong PTSD symptom improvement.
- Post Traumatic Stress Disorder
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: up to 12 weeks
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
Ketamine and Written Exposure Therapy
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Ketamine · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
New York | 100.0% |
How old are they?
18 - 65 | 100.0% |
What site did they apply to?
Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai | 100.0% |
What portion of applicants met pre-screening criteria?
Met criteria | 50.0% |
Did not meet criteria | 50.0% |
How many prior treatments have patients received?
0 | 100.0% |
Frequently Asked Questions
What is the government's opinion on Ketamine?
"Ketamine has received a 2. This is due to the lack of data regarding Ketamine's efficacy, despite there being some evidence supporting its safety as a medication." - Anonymous Online Contributor
Are there any patients participating in this research right now?
"Yes, the website clinicaltrials.gov indicates that this trial is still enrolling patients. The study was originally posted on June 4th 2021 and updated as recently as August 5th, 2022." - Anonymous Online Contributor
Might I be able to help with this research by enrolling in it?
"This clinical trial is seeking 30 individuals aged 18-70 who have moral injury and meet the following additional criteria: • Must be able to identify a family member, physician, or friend who will agree to the Treatment Contract (which includes contacting the study physician in case of manic symptoms or suicidal thoughts) • Must fulfill DSM-5 criteria for current civilian or combat-related PTSD, based on clinical assessment by a study psychiatrist and on the CAPS-5. A past-month total CAPS5 score ≥ 25 at screening is required to ensure at least moderate severity and reduce high placebo response rates. •" - Anonymous Online Contributor
Are elderly patients barred from participating in this research?
"In order to meet the requirements for this clinical trial, potential patients must 18 years old or older, but cannot be more than 70." - Anonymous Online Contributor