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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04077437
The ClinicalTrials.gov registry entry for NCT04077437 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Resilient Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04077437 reports 0 study locations.
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.
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