A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

Launched by LYKOS THERAPEUTICS · May 24, 2018

Keywords

ClinConnect Summary

This multi-site, double-blind, placebo-controlled, randomized Phase 3 study will assess the efficacy and safety of MDMA-assisted therapy versus placebo with therapy in participants diagnosed with at least severe PTSD. The study will be conducted in N ≈ 100 participants. Participants will be randomized to one of two groups at a 1:1 ratio. An initial dose of midomafetamine HCl or placebo, followed by a supplemental half-dose unless contraindicated, is administered during the Treatment Period with manualized therapy in three monthly Experimental Sessions. This \~12-week Treatment Period is pre...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Are at least 18 years old
• • Are fluent in speaking and reading the predominantly used or recognized language of the study site
• • Are able to swallow pills
• • Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
• • Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
• • Must agree to inform the investigators within 48 hours of any medical conditions and procedures
• • If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
• • Must not participate in any other interventional clinical trials during the duration of the study
• • Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures
• • At baseline, meet DSM-5 criteria for current severe PTSD
• Exclusion Criteria:
• • Are not able to give adequate informed consent
• • Have uncontrolled hypertension
• • Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] in males and \>460 ms in females corrected by Bazett's formula)
• • Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
• • Have evidence or history of significant medical disorders, such as myocardial infarction, cerebrovascular accident, or aneurysm
• • Have symptomatic liver disease
• • Have history of hyponatremia or hyperthermia
• • Weigh less than 48 kilograms (kg)
• • Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control
• • Have an active illicit or prescription drug use disorder
• • Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a MAPS-sponsored MDMA clinical trial.