← Back to Search

NMDA Receptor Antagonist

Ketamine-Enhanced Psychotherapy for PTSD

Phase 2
Recruiting
Led By Ilan Harpaz-Rotem, PhD ABPP
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female between the ages of 21-70 years
Diagnosis of PTSD with a score of 25 or higher (i.e. severe PTSD) on the Clinician-Administered PTSD Scale (CAPS-5) at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 7 days, 30 days and 90 days
Awards & highlights

Study Summary

This trial will test if ketamine + intensive psychotherapy can help relieve PTSD faster than midazolam + psychotherapy. It may produce significant changes in a week, vs months.

Who is the study for?
Adults aged 21-70 with severe PTSD who can read and write English may join this trial. They must not be pregnant, agree to birth control if applicable, have stable mental health without certain disorders like schizophrenia or bipolar mania recently, and no recent substance abuse. Participants should not have medical conditions that make ketamine unsafe.Check my eligibility
What is being tested?
The study is testing whether a week-long intensive psychotherapy combined with either ketamine or midazolam is more effective for treating PTSD. It aims to achieve results faster than traditional methods and will also examine changes in brain function as a result of the treatment.See study design
What are the potential side effects?
Ketamine might cause disorientation, dizziness, nausea, increased blood pressure, mood swings, or dissociative experiences. Midazolam can lead to sleepiness, memory issues, reduced alertness and coordination problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 70 years old.
Select...
I have severe PTSD with a CAPS-5 score of 25 or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 7 days, 30 days and 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 7 days, 30 days and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Secondary outcome measures
Change from baseline to 90 days post treatment in Beck Depression Inventory (BDI-II)
Measure the changes in psychophysiological distress to trauma reminders as a result of the proposed intervention

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 0.5mg/kg ketamine with psychotherapyExperimental Treatment1 Intervention
2. Two infusions of Ketamine combined with trauma-focused psychotherapy. Low dose ketamine infusion will take place on day 2 and day 4, of the psychotherapy intervention. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state of ketamine infusion of 0.5 mg/kg for 40 minutes.
Group II: 0.2mg/kg ketamine with psychotherapyExperimental Treatment1 Intervention
Two infusions of low dose Ketamine combined with trauma-focused psychotherapy. Low dose ketamine infusion will take place on day 2 and day 4, of the psychotherapy intervention. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state of ketamine infusion of 0.2 mg/kg for 40 minutes.
Group III: Midazolam with psychotherapyActive Control1 Intervention
Midazolam combined with trauma-focused psychotherapy. Midazolam infusion procedure will take place on day 2 and day 4, of the psychotherapy intervention. A physician will oversee administer the Midazolam infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following midazolam infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady midazolam infusion at a rate 0.045 mg/kg for 40 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,279 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,537 Total Patients Enrolled
Ilan Harpaz-Rotem, PhD ABPPPrincipal InvestigatorYale University

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05737693 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Midazolam with psychotherapy, 0.5mg/kg ketamine with psychotherapy, 0.2mg/kg ketamine with psychotherapy
Post-Traumatic Stress Disorder Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT05737693 — Phase 2
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05737693 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05737693 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial accept participants who are past retirement age?

"As indicated in the inclusion criteria, only individuals between 21 and 70 may apply for this clinical trial. There are 44 studies dedicated to those under 18 while a seperate 328 trials cater to patients over 65 years old."

Answered by AI

Is this research actively seeking new participants?

"The medical trial is actively recruiting, as seen on the clinicaltrials.gov website. It was first advertised to potential participants on June 1st 2023 and has since been updated on May 18th 2023."

Answered by AI

How many patients are currently enrolled in this exploration of medical treatments?

"Affirmative. Clinicaltrials.gov hosts the official data which demonstrates that this medical trial is presently enrolling participants; it was initially posted on June 1st 2023 and most recently updated on May 18th 2023. The study seeks to include 162 patients at a single site."

Answered by AI

Has the FDA sanctioned a combination of 0.2mg/kg ketamine and psychotherapy?

"According to our team at Power, the safety of 0.2mg/kg ketamine combined with psychotherapy was rated a 2 on a scale from 1-3 due to Phase 2 trial data which confirms its general security but lacks efficacy evidence."

Answered by AI

Who are the potential participants for this research endeavor?

"This clinical trial seeks 162 individuals with post-traumatic stress disorder who range in age from 21 to 70. Primarily, the participants should be male or female and within this arbitrary age bracket due to prior research showing no adverse effects of ketamine on adults aged 18-20 being less than mature enough for such a protocol. Females may join if they are not expecting offspring and use medically accepted contraceptive methods (including oral contraceptives, injectable contraception, intrauterine devices etc.) or have gone through menopause for at least one year. Furthermore, applicants must possess severe PTSD as evidenced by CAPS-5 score of 25 or higher; furthermore"

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Yale University School of Medicine

What questions have other patients asked about this trial?

How long do appts usually take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I’m just wanting my life back. Pills im tired of pills. i microdosed with mushrooms for 2 months straight and they had a profound effect on my cognition my ability to retain in formation and my anxiety areound people. while on psilobybin i was nable to successfulley get rid of the nicotine, the thc and sugary drinks. and i even enrolled in collede. but now my doctor wants me to get off the mushrooms because i have had two spravado treatments so far. ao she gave me a low dose xanan so i can stop eating the mushrooms. ide like to get out of the bible belt and see if someone can actually help me the psilocybin worked like nothing ive ever used b4. they were coming from california. but everyone here in kentucky espically my mother treats me like im a drug addict because mushrooms help me with the ptsd from child hood trauma, and also getting beat on by several different partners. . my parents house getting shot up 3 times in one day. instead of my insurance paying for the spravato treatment, ide like u guys to pay me for a clinical trial because i have no job and no money. so the sooner twe get this ptsd **** under control the sooner i can get back to doing the job and the people thing. please help me!!!!!
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Enhancing Week-long Psychological Treatment for PTSD With Ketamine
2023. "Enhancing Week-long Psychological Treatment for PTSD With Ketamine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05737693.
All > Ptsd New York > Psychological
~108 spots leftby Aug 2030
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top