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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05066282
Recruitment Status : Enrolling by invitation
First Posted : October 4, 2021
Last Update Posted : January 24, 2024
Sponsor:
Information provided by (Responsible Party):
Lykos Therapeutics

Study Description
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Brief 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.

Condition or disease
PTSD

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : September 25, 2024
Estimated Study Completion Date : September 25, 2024
Groups and Cohorts
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Group/Cohort
Participants with past PTSD who received IMP in the main study


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: LTFU IR Assessments at Least 6 Months Since Last Experimental Session in Main Study (Visit 1) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05066282


Locations
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United States, California
USCF
San Francisco, California, United States, 94158
Canada, Quebec
Dr. Simon Amar Inc
Montreal, Quebec, Canada, H2W1Y9
Israel
Beer Yaakov Mental Health Center
Be'er Ya'aqov, Israel
Tel Hashomer
Tel Aviv, Israel
Sponsors and Collaborators
Lykos Therapeutics
More Information
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Responsible Party: Lykos Therapeutics
ClinicalTrials.gov Identifier: NCT05066282    
Other Study ID Numbers: MPLONG
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No