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

PTSD Clinical Trial

— MPLONG  

Official title:

Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05066282
• Other study ID #: MPLONG
• Status: Enrolling by invitation
• Start date: March 1, 2021
• Est. completion date: September 25, 2024

Study information

• Verified date: January 2024
• Source: Lykos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic Posttraumatic Stress Disorder (PTSD), independent of cause, is treatable with up to three sessions of MDMA-assisted therapy. 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 Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as a measure of PTSD symptom severity. 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.

Description:

The Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit research and education organization working as a clinical trial sponsor to obtain approval for the prescription use of 3,4-methylenedioxymethamphetamine (MDMA) as an adjunct to therapy for treatment of posttraumatic stress disorder (PTSD). Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic PTSD, independent of cause, is treatable with up to three sessions of MDMA-assisted therapy. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: September 25, 2024
• Est. primary completion date: September 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Locations

Country	Name	City	State
Canada	Dr. Simon Amar Inc	Montreal	Quebec
Israel	Beer Yaakov Mental Health Center	Be'er Ya'aqov
Israel	Tel Hashomer	Tel Aviv
United States	USCF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Lykos Therapeutics

Countries where clinical trial is conducted

United States,  Canada,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)