MDMA treatment for PTSD questioned before key FDA hearing

TThe MDMA research was her last hope. She had read headlines she celebrated an 83% response rate in a small, early study of the psychedelic for treating PTSD, and was counting on the new clinical trial to ease her own post-traumatic stress disorder. Instead, after her first MDMA session, she felt intense despair when her symptoms didn’t go away.

She described standing on a train platform, while on the phone with her study therapists, and considering jumping in front of a train, according to a video of the participant describing the experience at a 2016 psychedelic therapy conference seen by STAT . “For the first time in a very long time, I said, ‘I’m done,'” she told the audience. “The only thing running through my head is: ‘Why am I not the 83%?’”

Ultimately, the study participant, who STAT is not identifying to protect her personal medical information, told herself she couldn’t jump; she said she was concerned that this would be classified as a side effect and could threaten the success of the MDMA study — which was a crucial step in efforts to win approval of the drug by the Food and Drug Administration. Suicidal ideation should be considered a side effect, says Philip Corlett, a professor of psychiatry at Yale University. But the incident does not seem to be reflected in the published data from the trial onclinicaltrials.gov, the government register of trials and their outcomes.