18 and older, any sex, with PTSD. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in CAPS-5 Total Severity ScorePrimary· 13 weeks post-baseline
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item semi-structured interview assessing PTSD in the past month through diagnostic and symptom severity scores anchored to a DSM-5 defined traumatic event. The CAPS-5 produces a Total Severity Score based on severity of PTSD domains described in the DSM-5, as well as a categorical rating indicating whether a participant meets PTSD diagnostic criteria. CAPS-5 Total Symptom Severity scores range from 0 to 80 with higher values designating greater symptom severity. CAPS-5 assigns PTSD diagnosis as being present or absent.
The Sheehan Disability Scale (SDS) is a clinician-rated assessment of functional impairment for PTSD. The SDS is a 3-item scale measuring the severity of disability (i.e., the degree of impairment) in the domains of work, family life/home responsibilities and social/leisure activities. Responses are recorded using an 11-point scale (0 = not at all to 10 = extremely) and 5 verbal tags (not at all, mildly, moderately, markedly, extremely). For participants who are not able to work for reasons unrelated to PTSD, the measure includes an option to skip the work-related impairment item, and the reas
Family Life / Home
Group
Value
95% CI
Experimental: MDMA-assisted Psychotherapy
-1.18
-2.14 – -0.22
Social / Leisure Activities
Group
Value
95% CI
Experimental: MDMA-assisted Psychotherapy
-1.45
-2.32 – -0.58
Work / School
Group
Value
95% CI
Experimental: MDMA-assisted Psychotherapy
-1.45
-2.36 – -0.53
Total Score
Group
Value
95% CI
Experimental: MDMA-assisted Psychotherapy
-1.30
-2.17 – -0.43
Adverse events — posted to ClinicalTrials.gov
Time frame: Approximately 8 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MAPS Europe B.V.
Last refreshed: 28 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04030169.