Phase 2 PTSD Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 21 and 70 years old (male or female).
- If you are a woman who could become pregnant, you agree to use an accepted form of birth control, or you are post-menopausal for at least 1 year, or have had a surgical procedure that prevents pregnancy.
- You do not have a medical or brain condition, and are not taking a medication, that would make the study drug (ketamine) unsafe for you.
- You have been diagnosed with chronic PTSD with a severe score (25 or higher) on a standard PTSD assessment scale, and your PTSD symptoms have lasted more than 1 year since the traumatic event.
- If you are currently taking certain approved antidepressants or related medications, you have been on a stable dose for at least 4 weeks before joining.
- You are able to read, write, and give your consent in English.
Who may not be able to join:
- You have a diagnosis of borderline personality disorder, obsessive-compulsive disorder, schizophrenia, schizoaffective disorder, or dementia, or you are currently showing signs of psychosis.
- You have bipolar disorder and have had a manic or hypomanic episode within the past 30 days.
- You have a history of mania or hypomania caused by antidepressant medication.
- You are currently considered to be at serious risk of suicide, based on a standard assessment.
- You have had a moderate or severe substance use disorder (not including alcohol or marijuana) in the past 3 months.
- You are currently taking a medication on the study's prohibited list — including certain antidepressants called MAOIs, memantine, or certain long-acting benzodiazepines — and have not been off them for the required amount of time (confirm with trial site).
- You have had a serious traumatic brain injury with a loss of consciousness for more than 24 hours or memory loss for more than 7 days, unless it happened more than 1 year ago and you have had minimal symptoms since (confirm with trial site).
- You have a positive pregnancy test at any point during the study, or you are breastfeeding.
- You have any alcohol in your system at screening or before receiving the study drug.
- Your resting blood pressure is below 90/60 or above 150/90, or your resting heart rate is below 45 or above 100 beats per minute.
- You have a significant history of serious medical or neurological illness.
- Tests such as an ECG, physical exam, or lab work show signs of a major medical or neurological condition.
- You test positive for drugs on a urine drug screen at screening.
- You have a known learning disability or intellectual disability.
- You have a known allergy or sensitivity to ketamine.
- Your body circumference is 52 inches or more, or you weigh 350 pounds or more.
- You have a history of claustrophobia (fear of enclosed spaces).
- You have a pacemaker, other electronic implant, or metal objects in your body that would make an MRI scan unsafe.
- You have donated more than 500 mL of blood in the 56 days before starting the study.
- You have a history of sensitivity to heparin (a blood-thinning medication) or a related blood disorder.
- You have recently started (within the past 3 months) a structured, trauma-focused therapy such as CBT, CPT, PE, or EMDR for PTSD.
- You are currently enrolled in, or recently joined (within the past 2 months), another research study testing an experimental treatment.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Ilan Harpaz-Rotem, PhD ABPP, Yale University
Phone: (203)937-4760
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Amygdala activation to trauma memory (Phase 1; R61); To determine if ketamine + exposure therapy results in clinical improvement in PTSD symptoms which are significantly greater than midazolam + exposure therapy (Phase 2; combined R61/R33 data); To determine if ketamine + exposure therapy results in more profound changes in task-based connectivity in region of interest than midazolam + exposure therapy (Phase 2; combined R61/R33 data)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.