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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01793610
The ClinicalTrials.gov registry entry for NCT01793610 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 29 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 4 interventions - of which Psychotherapy is the first listed.
NCT01793610 reports 0 study locations.
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.
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