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NCT04714359 · ClinicalTrials.gov registry record · Phase 3
A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD
A Phase 3 study, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 87
- Enrollment target
NCT04714359: Completed Phase 3 study, sponsored by Resilient Pharmaceuticals.
NCT04714359 is a Phase 3 study that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 87 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04714359, a Phase 3 study, has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with PTSD who received placebo in a prior MDMA-assisted therapy study. The main question it aims to answer is: Do PTSD symptoms decrease in people who receive a flexible dose of MDMA (120 or 180 mg MDMA HCl) with therapy in three sessions? Participants will undergo three preparatory therapy sessions without any study drug, then three MDMA-assisted therapy sessions with a flexible dose of 80 or 120 mg, followed by three integrative therapy sessions without study drug after each MDMA-assisted therapy session.
Primary Outcome
The Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. Participants indicate how much distress they have experienced in the last 2 weeks due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past,"
Interventions
- DRUG Midomafetamine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2023-11-06 |
| Phase | Phase 3 |
What the finished NCT04714359 record still lists
NCT04714359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Midomafetamine HCl is the first listed.
NCT04714359 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04714359 about?
NCT04714359 is a clinical study titled "A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD". The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with PTSD who received placebo in a prior MDMA-assisted therapy study. The main question it aims to answer is: Do PTSD symptoms decrease in people who receive a flexible d...
What is the current status of trial NCT04714359?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2021-03-08. Estimated completion is 2023-11-06.
What interventions are being tested in trial NCT04714359?
The interventions under investigation include: Midomafetamine HCl (DRUG).
Who is sponsoring clinical trial NCT04714359?
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 NCT04714359's enrollment target sits among peer trials
87 1742nd of 2000 higher than 256 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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