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NCT05066282 · ClinicalTrials.gov registry record
Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD
A clinical trial, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- 186
- Enrollment target
NCT05066282: Completed study, sponsored by Resilient Pharmaceuticals.
NCT05066282 is a clinical trial that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 186 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05066282 has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- 186 participants
- Enrollment target
Study Summary
The goal of this long-term follow-up study is to measure how long effects of MDMA-assisted therapy last in participants with PTSD who were treated in a prior Phase 3 clinical trial of MDMA-assisted therapy. The main question it aims to answer is: Does MDMA-assisted therapy result in lasting reductions in PTSD symptoms? Participants who have received at least one dose of MDMA-assisted therapy will take a PTSD assessment at least six months after their last MDMA-assisted therapy session in the main study.
Primary Outcome
The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2024-05-21 |
What the finished NCT05066282 record still lists
NCT05066282 is an observational study that tracks outcomes without assigning an intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT05066282 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05066282 about?
NCT05066282 is a clinical study titled "Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD". The goal of this long-term follow-up study is to measure how long effects of MDMA-assisted therapy last in participants with PTSD who were treated in a prior Phase 3 clinical trial of MDMA-assisted therapy. The main question it aims to answer is: Does MDMA-assisted therapy result in lasting reducti...
What is the current status of trial NCT05066282?
This trial is currently completed. The enrollment target is 186 participants. The study started on 2021-03-01. Estimated completion is 2024-05-21.
Who is sponsoring clinical trial NCT05066282?
This trial is sponsored by Resilient Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
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