The TGA has released the findings from an independent review of the therapeutic value, benefits and risks of MDMA and psilocybin for the treatment of mental health conditions.
The review panel examined eight studies on MDMA and six on psilocybin. Indications of interest included post-traumatic stress disorder (PTSD), treatment-resistant depression, obsessive-compulsive disorder, social anxiety in adults with autism, and anxiety or depression in life threatening disease.
In the case of MDMA, six of the eight studies were on PTSD, one on anxiety due to a life-threatening disease and the other on social anxiety in adults with autism. Half used inactive placebo as the control while the remainder used low doses of MDMA. In all studies both groups received supplementary psychotherapy.
In the case of psilocybin, four of the six studies were for anxiety or depression for a life-threatening disease, two on treatment-resistant depression and one on obsessive-compulsive disorder. Two used low-dose psilocybin as the control and another two used the vasodilator niacin as it induces a mild physiological reaction (eg flushing) without any psychological effects.
Psilocybin was also well tolerated in all the studies. The main effects were anxiety, headache and transient increases in blood pressure.
The panel said: “By combining the effects of small and possibly underpowered studies, meta-analyses can help to establish the relative efficacy of interventions such as MDMA and psilocybin where large studies may be impractical.
“Although we were only able to combine results from nine studies for either beneficial or adverse effects, we did demonstrate statistically significant differences of the two psychedelic agents between both inactive and active treatments for either continuous scores or dichotomous responses. However, it is important to note that this was in highly supportive and structured environments including intense psychotherapy sessions in many cases.”
It added both agents were well-tolerated in supervised trials with or without additional use of psychotherapy. However, trial quality including blinding and follow-up was variable and only a small proportion of potential participants were included in the randomised phase.
The panel concluded: “MDMA and psilocybin may show promise in highly selected populations, but only where these medicines are administered in closely clinically supervised settings and with intensive professional support.”
The TGA Scheduling Delegate deferred a final decision on applications to down-schedule MDMA and psilocybin from schedule 9 (prohibited drug) to schedule 8 (controlled drug) pending the review.
The panel’s report will be considered by the Advisory Committee of Medicines Scheduling (ACMS) on November 3 with the Delegate’s final decision expected to be published during the first week of December.