Clinical trial NCT05066282: Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD
Official title: Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Lead sponsor: Lykos Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-10-04
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: LTFU IR Assessments at Least 6 Months Since Last Experimental Session in Main Study (Visit 1)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: USCF
state: California
city: Montreal
country: Canada
facility: Dr. Simon Amar Inc
state: Quebec
city: Be'er Ya'aqov
country: Israel
facility: Beer Yaakov Mental Health Center
city: Tel Aviv
country: Israel
facility: Tel Hashomer
Study officials:
affiliation: University of California, San Francisco
name: Jennifer Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References: