Trial for PTSD treatment with MDMA-assisted psychotherapy receives FDA go-ahead

By Dr. Ananya Mandal, MDAug 28 2017

The United States Food and Drugs Administration FDA has granted permission for phase 3 trials in PTSD (Post traumatic stress disorder) patients using 3,4-methylenedioxy-methamphetamine (MDMA) and psychotherapy in a treatment protocol called MDMA-Assisted Psychotherapy PTSD affects thousands of war veterans and other individuals and often leads to fatal outcomes of self-harm and suicides. MDMA is commonly known as ecstasy (E).

There are available treatments which are not always effective and MAPS could fill this gap feel researchers. Multidisciplinary Association for Psychedelic Studies or MAPS is a non-profit research organization that has already raised half of the proposed $25 million that would be needed to conduct clinical trials.

The study is designed and planned with both the MAPS team and FDA in agreement. There would be two Phase 3 clinical trials of MDMA-assisted psychotherapy sponsored by MAPS starting in 2018 in patients suffering from severe PTSD.

The researchers at MAPS have found that MDMA or street drug of abuse – ecstasy and psychotherapy in a novel treatment package could help patients with PTSD. The package includes psychotherapeutic techniques and along with it MDMA (approved generic name: midomafetamine) is used as the pharmacological agent. The FDA, in a press release that agreed to grant a Breakthrough Therapy Designation to this treatment giving it an advantage over other ongoing researches in PTSD.

The first of the two studies is entitled, “A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder” and would start to include patients in the early 2018. A preliminary lead-in study would begin this fall that would precede the MAPP1 trial. Amy Emerson, Executive Director of the MAPS Public Benefit Corporation (MPBC) said that the team was intending to work closely with the FDA on this and their earlier phase 2 clinical trial data was encouraging with good evidence of efficacy of this novel treatment approach. According to Rick Doblin, Founder and Executive Director of MAPS this would be the first in the line of clinical trials that used psychedelic therapy along with psychotherapy in PTSD patients. After FDA, the team would now plan to work in collaboration with the European Medicines Agency (EMA) too.

For the phase 3 trials MAPS would recruit 200 to 300 participants with PTSD aged over 18 years. The sites planned would be in U.S., Canada, and Israel. Over a treatment period of 12 weeks, the participants would receive three day-long sessions of either MDMA or placebo along with psychotherapy. Along with these would be 12 associated 90-minute non-drug preparatory and integration sessions. Raters independent of the study would assess the participants at the end of the study using a standardized PTSD rating scale called the Clinician Administered PTSD Scale (CAPS-5) to check for improvements if any. These raters would not know if they were assessing those given MDMA or placebo.

Earlier phase 2 trials that have shown the efficacy of MDMA assisted psychotherapy including 107 participants. After three sessions of the MDMA assisted psychotherapy sessions 61 percent of the participants did not qualify as having PTSD at the end of two months of treatment. At the end of the year 68 percent of the participants did not have PTSD. The participants of these trials were all chronic sufferers of PTSD who had suffered for an average of 17.8 years and were resistant to existing therapies.

The early trials have also assessed the safety of MDMA. MDMA administration is associated with raised heart rate, blood pressure and body temperature. But these are usually not worrisome for physically healthy individuals. Phase 2 trial results would soon be published in peer reviewed journals.

Source: http://www.maps.org/news/media/6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials