Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD

NCT05066282 | Completed

• 1 other identifier: MPLONG
• Study Type: observational
• Target: 186
• Locations: 3 countries
• Sites: 4

Brief Summary

The goal of this long-term follow-up study is to measure how long effects of MDMA-assisted therapy last in participants with PTSD who were treated in a prior Phase 3 clinical trial of MDMA-assisted therapy. The main question it aims to answer is: Does MDMA-assisted therapy result in lasting reductions in PTSD symptoms? Participants who have received at least one dose of MDMA-assisted therapy will take a PTSD assessment at least six months after their last MDMA-assisted therapy session in the main study.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale for DSM-V (CAPS-5) Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to assessment in the current LTFU study

  The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. 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 of PTSD symptoms.

  LTFU IR Assessments at Least 6 Months Since Last Experimental Session in Main Study (Visit 1)

Study Arms (1)

Participants with past PTSD who received IMP in the main study

Non-interventional follow-up study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with past posttraumatic stress disorder (PTSD) who have completed at least one Experimental Session in the main study protocol.

You may qualify if:

• Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD
• Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study
• Agree to be contacted by study team at least six months after the last Experimental Session in the main study to schedule and participate in LTFU visits

You may not qualify if:

• Are not able to give adequate informed consent
• Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (4)

USCF

San Francisco, California, 94158, United States

Location

Dr. Simon Amar Inc

Montreal, Quebec, H2W1Y9, Canada

Location

Beer Yaakov Mental Health Center

Be’er Ya‘aqov, Israel

Location

Tel Hashomer

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jennifer Mitchell, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: March 1, 2021
• Primary Completion: May 16, 2024
• Study Completion: May 21, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); IL (2); US (1)