Phase 3: MDMA-Assisted Therapy for PTSD
An overview of the MAPS study, study sites, prior results, and ways to get involved with participating in existing studies and getting trained through the MAPS MDMA Therapist Program
Phase 3 MDMA PTSD Summary
Studies MAPP1 and MAPP2 are randomized, double-blind, placebo-controlled, multi-site clinical trials that assess the safety and efficacy of MDMA-assisted therapy in 200-300 participants with severe posttraumatic stress disorder (PTSD) from any cause, aged 18 and older.
The trials build on the promising results of MAPS’ completed Phase 2 clinical trials, and are the final phase of research required by the U.S. Food and Drug Administration (FDA) before deciding whether to approve MDMA as a legal prescription treatment for PTSD, required to be used in conjunction with therapy in an outpatient setting with a residential stay.
On August 16, 2017, the FDA granted Breakthrough Therapy Designation to MDMA for the treatment of PTSD. The FDA grants this designation for treatments that (1) are intended alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and (2) preliminary clinical evidence indicates may demonstrate substantial improvement over existing therapies. Breakthrough Therapy Designation also means that the FDA will work closely with MAPS to provide guidance on the development of MDMA for post-traumatic stress disorder to design and conduct the development program as efficiently as possible.
On July 28, 2017, MAPS and the FDA reached agreement on the Special Protocol Assessment for Phase 3 clinical trials. This agreement confirms that the protocol design, clinical endpoints, planned conduct, and statistical analyses for the Phase 3 trials (MAPP1 and MAPP2) are acceptable to support regulatory approval by the FDA.