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NCT06215261 · ClinicalTrials.gov registry record · Phase 2
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD
A Phase 2 study, sponsored by Transcend Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT06215261: Completed Phase 2 study, sponsored by Transcend Therapeutics.
NCT06215261 is a Phase 2 study that has completed, run by Transcend Therapeutics. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06215261, a Phase 2 study, has completed, sponsored by Transcend Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts. * Part A is open-label and will enroll up to 15 participants with PTSD * Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).
Primary Outcome
The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
Interventions
- DRUG Methylone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2024-04-04 |
| Est. Completion | 2025-09-23 |
| Phase | Phase 2 |
What the finished NCT06215261 record still lists
NCT06215261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Methylone is the first listed.
NCT06215261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06215261 about?
NCT06215261 is a clinical study titled "An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD". This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts. * Part A is open-label and will enroll up to 15 participants with PTSD * Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD Eligible parti...
What is the current status of trial NCT06215261?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2024-04-04. Estimated completion is 2025-09-23.
What interventions are being tested in trial NCT06215261?
The interventions under investigation include: Methylone (DRUG).
Who is sponsoring clinical trial NCT06215261?
This trial is sponsored by Transcend Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06215261's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 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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