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NCT01793610 · ClinicalTrials.gov registry record · Phase 2
Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD
A Phase 2 study, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT01793610: Completed Phase 2 study, sponsored by Resilient Pharmaceuticals.
NCT01793610 is a Phase 2 study that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01793610, a Phase 2 study, has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if MDMA in combination with therapy is safe and effective in people with chronic, treatment-resistant PTSD. The main questions it aims to answer are: * Does MDMA-assisted therapy reduce PTSD symptoms? * Is there a difference in PTSD symptoms between the 40 mg, 100 mg, and 125 mg groups? Researchers will compare two active doses (100 mg and 125 mg) of MDMA-assisted therapy versus a comparator dose of 40 mg MDMA-assisted therapy to determine if there is a reduction in PTSD symptoms. Participants will undergo three non-drug preparatory sessions, three MDMA-assisted therapy sessions and three non-drug integrative therapy sessions after each MDMA-assisted therapy session.
Primary Outcome
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. 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
Interventions
- BEHAVIORAL Psychotherapy
- DRUG Comparator Dose (40mg) MDMA HCl
- DRUG Active Dose 2 (100 mg) MDMA HCl
- DRUG Active Dose 1 (125 mg) MDMA HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2013-05-13 |
| Est. Completion | 2017-02-01 |
| Phase | Phase 2 |
What the finished NCT01793610 record still lists
NCT01793610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Psychotherapy is the first listed.
NCT01793610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01793610 about?
NCT01793610 is a clinical study titled "Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD". The goal of this clinical trial is to learn if MDMA in combination with therapy is safe and effective in people with chronic, treatment-resistant PTSD. The main questions it aims to answer are: * Does MDMA-assisted therapy reduce PTSD symptoms? * Is there a difference in PTSD symptoms between the ...
What is the current status of trial NCT01793610?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2013-05-13. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT01793610?
The interventions under investigation include: Psychotherapy (BEHAVIORAL), Comparator Dose (40mg) MDMA HCl (DRUG), Active Dose 2 (100 mg) MDMA HCl (DRUG), Active Dose 1 (125 mg) MDMA HCl (DRUG).
Who is sponsoring clinical trial NCT01793610?
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 NCT01793610's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 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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