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NCT04784143 · ClinicalTrials.gov registry record · Phase 2
Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD
A Phase 2 study, sponsored by Resilient Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT04784143: Clinical Trial Phase 2 study, sponsored by Resilient Pharmaceuticals.
NCT04784143 is a Phase 2 study that was terminated before completion, run by Resilient Pharmaceuticals. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04784143, a Phase 2 study, was terminated before completion, sponsored by Resilient Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is effective in U.S. military veterans with at least moderate chronic PTSD. The main question it aims to answer is: Are two versus three MDMA-assisted therapy sessions in an outpatient treatment clinic more effective? Researchers will compare two MDMA-assisted therapy sessions to three MDMA-assisted therapy sessions. Participants will undergo three non-drug preparatory sessions prior to their first MDMA-assisted therapy session. Each MDMA-assisted therapy session will be followed by three non-drug integrative therapy sessions.
Primary Outcome
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 indica
Interventions
- BEHAVIORAL Psychotherapy
- DRUG Midomafetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-11-08 |
| Est. Completion | 2024-06-27 |
| Phase | Phase 2 |
Why NCT04784143 stopped before completion
NCT04784143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Psychotherapy is the first listed.
NCT04784143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04784143 about?
NCT04784143 is a clinical study titled "Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD". The goal of this clinical trial is to learn if MDMA-assisted therapy is effective in U.S. military veterans with at least moderate chronic PTSD. The main question it aims to answer is: Are two versus three MDMA-assisted therapy sessions in an outpatient treatment clinic more effective? Researchers ...
What is the current status of trial NCT04784143?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2021-11-08. Estimated completion is 2024-06-27.
What interventions are being tested in trial NCT04784143?
The interventions under investigation include: Psychotherapy (BEHAVIORAL), Midomafetamine (DRUG).
Who is sponsoring clinical trial NCT04784143?
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 NCT04784143's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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