The F.D.A. is weighing whether to approve MDMA-assisted therapy as a new option.
Post-traumatic stress disorder closes people off. They withdraw — often reluctant to talk about what they’ve experienced and unable to trust others or themselves. But many leading treatments for the condition require just that.
The treatments for PTSD — including several forms of psychotherapy and medication — are effective for many patients, but they don’t work for everyone. They can be expensive. Sometimes, they can be so distressing that patients stop the treatment before it’s complete.
“The field has acknowledged for years that we need to do better for our patients,” Dr. Jerry Rosenbaum, a professor of psychiatry at Harvard Medical School, said Tuesday at a meeting of experts tasked with advising the Food and Drug Administration on whether to approve the first new medication in decades for PTSD.
The treatment would use the psychoactive drug MDMA, also known as Ecstasy, in combination with talk therapy to relieve symptoms of the disorder, which can cause intrusive thoughts, flashbacks and nightmares and increases the risk of suicide or death from other causes. Proponents say the drug can tamp down on patients’ fears and anxieties and help them to feel compassion for themselves as they work through their trauma in therapy. Two clinical trials have shown promising outcomes, but experts have raised concerns about how reliable the data is and how safe the drug may be.
Roughly six percent of the American population will develop PTSD at some point in their lives. Only a fraction of those patients currently recover, Dr. Tiffany R. Farchione, director of the F.D.A.’s Division of Psychiatry Products, said at the meeting Tuesday. And many people with PTSD symptoms struggle to get diagnosed in the first place.
How is PTSD diagnosed?
The gold standard for diagnosing PTSD is the Clinician Administered PTSD Scale, known as CAPS-5. Clinicians ask patients about symptoms and their severity, how often they re-experience unwanted memories, what measures they take to avoid reminders of traumatic events, and more.