The first-ever psilocybin trial for treatment-resistant bipolar type II disorder has shown 80% of participants meeting remission criteria 12 weeks after treatment.
JAMA Psychiatry recently published results from the first-of-its-kind clinical trial conducted at Sheppard Pratt. The study explored the efficacy and safety of a single dose of synthetic psilocybin accompanied by psychotherapy in treating individuals with treatment-resistant bipolar type II disorder (bipolar II).
The 12-week, open-label trial, initiated and led by Scott T. Aaronson, chief science officer of the Institute for Advanced Diagnostics and Therapeutics at Sheppard Pratt, and funded by Compass Pathways, included 15 participants aged 18 to 65 with treatment-resistant bipolar II.
Each participant had experienced an episode of bipolar II for a period greater than three months and documented at least two failed pharmacological treatments within the current episode.
After discontinuing psychotropic medications at least two weeks prior to the trial, participants were administered a single dose (25mg) of synthetic COMP360 psilocybin in a controlled setting.
Therapists held sessions with patients during the eight-hour dosing day as well as for three sessions prior to the trial’s start and for three integration sessions post-treatment. Funding for the study will also allow for patient results to be monitored up to two years following treatment.
Aaronson stated: “The results we saw from this trial are encouraging and further support the clinical study of psychedelics in patients with treatment-resistant bipolar II.
”One participant compared the transformation she experienced to taking a deep breath after breathing through a straw for years. These are the types of stories we are hearing from people who struggled with this disorder for years, many whom had lost hope that their bipolar II could ever be treated.”
In this small pilot study, there were no findings that patients had developed symptoms of psychosis during treatment and 73% of participants met remission criteria on the Montgomery Asberg Depression Rating Scale three weeks post-treatment.
A total of 80% also experienced remission with no increase in bipolar II symptoms such as mania, hypomania, or suicidality twelve weeks after treatment. The results of this study suggest the efficacy and safety of psilocybin in treatment of bipolar II depression, but cannot be extrapolated to the study of psilocybin to treat bipolar I disorder.
