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

Lykos Therapeutics

Status: Completed

Conditions: PTSD

Study type: Observational

Funder types: Industry

Identifiers

NCT05066282

MPLONG

Details and patient eligibility

About

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.

Full description

This non-interventional study will serve as the long-term follow-up (LTFU) protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the CAPS-5 as a measure of PTSD symptom severity. The primary objective of this study is to evaluate the long-term effectiveness of MDMA-assisted therapy for treatment of PTSD as measured by the change in CAPS-5 Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to LTFU IR Assessments (Visit 1). Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Enrolled in a MAPS-sponsored study of MDMA-assisted therapy for the treatment of PTSD
2. Have received Investigational Medicinal Product (IMP) in at least one Experimental Session in the main study
3. 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

Exclusion criteria

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

Trial design

186 participants in 1 patient group

Participants with past PTSD who received IMP in the main study

Description:

Non-interventional follow-up study