MDMA-Assisted Psychotherapy for the Treatment of PTSD
- Conditions
- post-traumatic stress disorder (PTSD)Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2018-001718-13-DE
- Lead Sponsor
- MAPS Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
- Are at least 18 years old
- Are fluent in speaking and reading the predominantly used or recognized language of the study site
- Are able to swallow pills
- Agree to have study visits video-recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
- Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable
- Must agree to inform the investigators within 48 hours of any medical treatments and procedures
- Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner. Not of childbearing potential is defined as permanent sterilization or assigned male at birth.
- Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.
- At Screening, meet DSM-5 criteria for current PTSD
- May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease
- May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
- Are not able to give adequate informed consent
- Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation
- Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist
- Require ongoing concomitant therapy with a psychiatric medication with exceptions described in Section 11.0: Concomitant Medications.
- Weigh less than 48 kilograms (kg)
- Are pregnant or nursing or are of childbearing potential and are not practicing an effective means of birth control.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method