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NCT02427568 · ClinicalTrials.gov registry record · Phase 2
MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
A Phase 2 study, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT02427568: Completed Phase 2 study, sponsored by Resilient Pharmaceuticals.
NCT02427568 is a Phase 2 study that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02427568, a Phase 2 study, has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with anxiety associated with a life-threatening illness. The main question it aims to answer is: Does anxiety decrease in people receiving two sessions of MDMA-assisted therapy? Researchers will compare people receiving placebo with therapy to people receiving MDMA-assisted therapy. * Participants will undergo three non-drug preparatory therapy sessions before their first blinded session of MDMA or placebo with therapy. * Each medication session will be followed by three non-drug integrative therapy sessions. * After the second blinded medication session, participants receiving MDMA will complete a third open-label medication session. * Participants who received placebo will be given the option to crossover and receive three sessions of assisted therapy.
Primary Outcome
The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervou
Interventions
- DRUG Placebo
- BEHAVIORAL Therapy
- DRUG Midomafetamine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-05-14 |
| Est. Completion | 2018-05-17 |
| Phase | Phase 2 |
What the finished NCT02427568 record still lists
NCT02427568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02427568 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02427568 about?
NCT02427568 is a clinical study titled "MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness". The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with anxiety associated with a life-threatening illness. The main question it aims to answer is: Does anxiety decrease in people receiving two sessions of MDMA-assisted therapy? Researchers will com...
What is the current status of trial NCT02427568?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2015-05-14. Estimated completion is 2018-05-17.
What interventions are being tested in trial NCT02427568?
The interventions under investigation include: Placebo (DRUG), Therapy (BEHAVIORAL), Midomafetamine HCl (DRUG).
Who is sponsoring clinical trial NCT02427568?
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 NCT02427568's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 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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