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

Long-Term Safety and Persistence of Effectiveness of Manualized MDMA Assisted Therapy for the Treatment of Posttraumatic Stress Disorder - Long-term follow-up of MDMA-assisted therapy for PTSD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005596-39-CZ

Enrollment

Registered

2022-03-11

Start date

2022-09-07

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-traumatic stress disorder (PTSD)

Interventions

Product Name: 3,4- methylenedioxymethamphetamine hydrochloride Product Code: MDMA HCI Pharmaceutical Form: Capsule

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison of PTSD severity between groups who received MDMA vs. Placebo during parent study based on LTFU IR assessment (Visit 1);Secondary Objective: Comparison of degree of functional impairment associated with PTSD between groups who received MDMA vs. Placebo during parent study based on LTFU IR assessment (Visit 1);Primary end point(s): CAPS-5 (Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th edition) Total Severity Score;Timepoint(s) of evaluation of this end point: Visit 1	—

Measure

Time frame

Main Objective: Comparison of PTSD severity between groups who received MDMA vs. Placebo during parent study based on LTFU IR assessment (Visit 1);Secondary Objective: Comparison of degree of functional impairment associated with PTSD between groups who received MDMA vs. Placebo during parent study based on LTFU IR assessment (Visit 1);Primary end point(s): CAPS-5 (Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th edition) Total Severity Score;Timepoint(s) of evaluation of this end point: Visit 1

—

Secondary

Measure	Time frame
Secondary end point(s): SDS (Sheehan Disability Scale) for PTSD for MAPS Total score;Timepoint(s) of evaluation of this end point: Visit 1	—

Countries

Czechia, Czech Republic, Germany, Netherlands, Norway, United Kingdom

Contacts

Public ContactClinical Operations

MAPS Europe B.V.

legalrep@mapseurope.eu312021 01363

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026