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NCT03537014 · ClinicalTrials.gov registry record · Phase 3
A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)
A Phase 3 study of Post Traumatic Stress Disorder, sponsored by Lykos Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 15
- Study locations
NCT03537014: Completed Phase 3 study of Post Traumatic Stress Disorder, sponsored by Lykos Therapeutics.
NCT03537014 is a Phase 3 study of Post Traumatic Stress Disorder that has completed, run by Lykos Therapeutics. The registered enrollment target is 100 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (85% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03537014, a Phase 3 study of Post Traumatic Stress Disorder, has completed, sponsored by Lykos Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 15
- Study locations
Study Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least severe PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy. Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.
Primary Outcome
The CAPS-5 is a 30-item semi-structured interview assessing PTSD in the past month through diagnostic and symptom severity scores anchored to a DSM-5 defined traumatic event. The CAPS-5 produces a Total Severity Score based on severity of PTSD domains described in the DSM-5, as well as a categorical rating indicating whether a participant meets PTSD diagnostic criteria. CAPS-5 Total Symptom Severity scores range from 0 to 80 with higher values indicating greater symptom severity. CAPS-5 assigns
Conditions Studied
Interventions
- DRUG Placebo
- BEHAVIORAL Therapy
- DRUG midomafetamine HCl
Study Locations (15)
California
- New School Research LLT - North Hollywood
- San Francisco Insight and Integration Center - San Francisco
- University of California San Francisco - San Francisco
Colorado
- Aguazul-Blue Water Inc. - Boulder
- Wholeness Center - Fort Collins
New York
- New York University - New York
- New York Private Practice - New York
Other
- Assaf Harofeh Research Fund - Be’er Ya‘aqov
- Sheba Fund for Health Services and Research - Tel Litwinsky
Louisiana
- Ray Worthy Psychiatry LLC - New Orleans
Massachusetts
- Trauma Research Foundation - Boston
South Carolina
- Zen Therapeutic Solutions, LLC - Mt. Pleasant
Wisconsin
- University of Wisconsin at Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-11-21 |
| Est. Completion | 2020-08-21 |
| Phase | Phase 3 |
What the finished NCT03537014 record still lists
NCT03537014 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03537014 lists 15 locations in 10 states (California, Colorado, New York).
Frequently Asked Questions
What is clinical trial NCT03537014 about?
NCT03537014 is a clinical study titled "A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)". The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least severe PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therapy ...
What is the current status of trial NCT03537014?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2018-11-21. Estimated completion is 2020-08-21.
What conditions does trial NCT03537014 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT03537014?
The interventions under investigation include: Placebo (DRUG), Therapy (BEHAVIORAL), midomafetamine HCl (DRUG).
Who is sponsoring clinical trial NCT03537014?
This trial is sponsored by Lykos Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03537014 being conducted?
This trial has 15 study locations across California, Colorado, Louisiana, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03537014's enrollment target sits among peer trials
100 112th of 262 higher than 149 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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.
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