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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 Posttraumatic Stress Disorder, sponsored by Lykos Therapeutics.

Completed
Registry status
Phase 3
Development phase
100
Enrollment target
15
Study locations

NCT03537014 is a Phase 3 study of Posttraumatic Stress Disorder that has completed, run by Lykos Therapeutics. The registered enrollment target is 100 participants, below the 111-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (10% lower). The trial reports 15 study locations across 10 states.

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The verdict

NCT03537014, a Phase 3 study of Posttraumatic 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.

Conditions Studied

Posttraumatic Stress Disorder

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

FieldValue
Enrollment Target 100 participants
Start Date 2018-11-21
Est. Completion 2020-08-21
Phase Phase 3

Sponsor

Lykos Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03537014

The ClinicalTrials.gov registry entry for NCT03537014 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 111-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (10% lower). The listed sponsor is Lykos Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03537014 reports 15 study locations spanning 10 distinct geographic areas - top geographies include 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: Posttraumatic 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.