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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01458327
The ClinicalTrials.gov registry entry for NCT01458327 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Resilient Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Midomafetamine is the first listed.
NCT01458327 reports 0 study locations.
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.
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