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NCT01458327 · ClinicalTrials.gov registry record · Phase 2
Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial
A Phase 2 study, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01458327: Completed Phase 2 study, sponsored by Resilient Pharmaceuticals.
NCT01458327 is a Phase 2 study that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01458327, a Phase 2 study, has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.
Primary Outcome
The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD sympt
Interventions
- DRUG Midomafetamine
- BEHAVIORAL Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-12-15 |
| Est. Completion | 2014-06-27 |
| Phase | Phase 2 |
What the finished NCT01458327 record still lists
NCT01458327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Midomafetamine is the first listed.
NCT01458327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01458327 about?
NCT01458327 is a clinical study titled "Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial". This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. ...
What is the current status of trial NCT01458327?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2010-12-15. Estimated completion is 2014-06-27.
What interventions are being tested in trial NCT01458327?
The interventions under investigation include: Midomafetamine (DRUG), Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01458327?
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 NCT01458327's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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