Actively Recruiting
Enhancing Week-long Psychological Treatment for PTSD With Ketamine
Led by Yale University · Updated on 2025-05-07
162
Participants Needed
2
Research Sites
414 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Enhancing Week-long Psychological Treatment for PTSD With Ketamine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between the ages of 21-70 years
- Females must not be pregnant and must use medically accepted birth control or be post-menopausal for at least 1 year or surgically sterile
- No medical or neurological problems or medications that make ketamine unsafe
- Diagnosis of chronic PTSD with a Clinician-Administered PTSD Scale (CAPS-5) score of 25 or higher
- PTSD symptoms must have lasted more than 1 year after trauma exposure
- Stable use of FDA-approved antidepressants or certain other medications for at least 4 weeks before randomization
- Able to provide written informed consent
- Able to read and write English
You will not qualify if you...
- History of borderline personality disorder, obsessive compulsive disorder, schizophrenia, schizoaffective disorder, or current psychotic features
- Dementia or suspicion of dementia
- Bipolar disorder with manic or hypomanic episode in last 30 days
- History of antidepressant-induced hypomania or mania
- Current serious suicidal risk
- Moderate or greater substance use disorder (except alcohol or marijuana) in past 3 months
- Use of prohibited medications within specified washout periods
- History of traumatic brain injury with prolonged loss of consciousness or amnesia unless minimal symptoms for over 1 year
- Positive pregnancy test or breastfeeding
- Alcohol detected at screening or before drug infusion
- Blood pressure or heart rate outside specified limits
- Significant serious medical or neurological illness
- Abnormal physical exam or ECG lab results unless deemed safe
- Positive urine drug screen before scans
- History of learning disability or mental retardation
- Known sensitivity to ketamine
- Body circumference 52 inches or greater
- Body weight 350 pounds or greater
- History of claustrophobia
- Presence of cardiac pacemaker or other electronic or ferromagnetic devices incompatible with MRI
- Recent blood donation exceeding 500 mL within 56 days
- History of heparin sensitivity or heparin-induced thrombocytopenia
- Active trauma-focused CBT or PTSD psychotherapy started within past 3 months
- Participation in another experimental clinical or behavioral study within last 2 months or planned within next 3 months
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Tel Aviv University
Tel Aviv, Israel
Actively Recruiting
Research Team
C
Charles Gordon, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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