CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Midomafetamine HCldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04030169
NCT04030169Phase 2Completed
CompareCT.gov

An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA-Assisted Psychotherapy With an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects With Posttraumatic Stress Disorder

MAPS Europe B.V.·interventional·Posted Jul 23, 2019·Updated Jan 28, 2025

In Brief

A Phase 2 clinical trial evaluating Midomafetamine HCl for PTSD. Completed, enrolled 21 participants across 6 sites in 5 countries.

Detailed Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD. The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will receive three non-drug preparatory sessions followed by two sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
CountriesCzechia, Germany, Netherlands, Norway, United Kingdom
CollaboratorsMultidisciplinary Association for Psychedelic Studies

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 23, 2019
Enrollment StartJun 24, 2020
Primary CompletionDec 14, 2023
Study CompletionDec 15, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.9 years ago

Interventions

Midomafetamine HCldrug

Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session