ong-term follow-up of safety and effectiveness of MDMA-assisted therapy for posttraumatic stress disorder

Phase 1

• Conditions: post-traumatic stress disorder (PTSD); Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-005596-39-CZ
• Lead Sponsor: MAPS Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-11
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. At least 18 years of age at the time of signing the informed consent.
2. Previously enrolled in a MAPS Europe sponsored study of MDMA assisted therapy for the treatment of PTSD.
3. Have received at least one dose of Investigational Medicinal Product (IMP) in the parent study.
4. Agree to be contacted by a study team at least 6 months after the last Experimental Session in the parent study to schedule and participate in LTFU assessments.
5. Agree to have Independent Rater assessments video-recorded.
6. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

1. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified