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NCT04077437 · ClinicalTrials.gov registry record · Phase 3
A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)
A Phase 3 study, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 121
- Enrollment target
NCT04077437: Completed Phase 3 study, sponsored by Resilient Pharmaceuticals.
NCT04077437 is a Phase 3 study that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 121 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04077437, a Phase 3 study, has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 121 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least moderate PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy. Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.
Primary Outcome
The 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 indicating greater symptom severity. CAPS-5 assigns
Interventions
- DRUG Placebo
- DRUG Midomafetamine
- BEHAVIORAL Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2020-09-02 |
| Est. Completion | 2022-11-02 |
| Phase | Phase 3 |
What the finished NCT04077437 record still lists
NCT04077437 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04077437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04077437 about?
NCT04077437 is a clinical study titled "A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)". The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least moderate PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therap...
What is the current status of trial NCT04077437?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 121 participants. The study started on 2020-09-02. Estimated completion is 2022-11-02.
What interventions are being tested in trial NCT04077437?
The interventions under investigation include: Placebo (DRUG), Midomafetamine (DRUG), Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04077437?
This trial is sponsored by Resilient Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04077437's enrollment target sits among peer trials
121 1619th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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