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.
- Post Traumatic Stress Disorder
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
3 Primary · 2 Secondary · Reporting Duration: Baseline, 7 days, 30 days and 90 days
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
3 Treatment Groups
Midazolam with psychotherapy
1 of 3
0.2mg/kg ketamine with psychotherapy
1 of 3
0.5mg/kg ketamine with psychotherapy
1 of 3
Active Control
Experimental Treatment
162 Total Participants · 3 Treatment Groups
Primary Treatment: 0.2mg/kg ketamine with psychotherapy · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 21 - 70 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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" - Anonymous Online Contributor