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Use of Psilocbyin in Bipolar II Treatment Clinical Trial Produces Strong Results
In a recent clinical trial to study the efficacy and safety of a single dose of synthetic psilocybin accompanied by psychotherapy to treat individuals with treatment-resistant bipolar type II disorder (bipolar II), 80% of participants met the criteria for remission 12 weeks after treatment.
Findings from the study were published in JAMA Psychiatry.
The 12-week, open-label trial was initiated and led by Scott T. Aaronson, MD, chief science officer for the Institute for Advanced Diagnostics and Therapeutics at Sheppard Pratt, and funded by Compass Pathways. The study included 15 participants between the ages of 18 and 65 with treatment-resistant bipolar II.
“The results we saw from this trial are encouraging and further support the clinical study of psychedelics in patients with treatment-resistant bipolar II,” Dr Aaronson said in a news release. “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.”
Each individual who participated in the study had experienced a bipolar II episode for a period greater than 3 months and documented at least 2 failed pharmacological treatments within their current episode.
Prior to beginning the trial, participants discontinued psychotropic medications for at least 2 weeks and had 3 sessions of therapy. During an 8-hour dosing day, the participants received a single 25-mg dose of synthetic COMP360 psilocybin in a controlled setting and participated in a therapy session. Therapists also held 3 integration sessions for participants post-dosing. Patients will continue to be monitored for up to 2 years following treatment.
The study produced no findings that patients had developed symptoms of psychosis during treatment. On the Montgomery Asberg Depression Rating Scale (MADRS), 73% of participants met remission criteria 3 weeks after treatment, with 80% experiencing remission with no increase in bipolar II symptoms—such as mania, hypomania, or suicidality—after 12 weeks.
While the study results suggest efficacy and safety of psilocybin treatment for bipolar II depression, the results cannot be extrapolated to the study of psilocybin to treat bipolar I, according to Sheppard Pratt’s news release.
Meanwhile, at its Center of Excellence for Psilocybin Research and Treatment, the company is also conducting clinical trials on the use of psilocybin with psychotherapy as a treatment for anorexia, treatment-resistant depression, and chronic suicide ideation.
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