A single dose of psilocybin could help patients with treatment-resistant depression, according to a new study.
According to the results of a phase 2b trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD), the largest study of its kind, patients with TRD could see symptom relief after a single dose of psilocybin.1
Investigators gathered 233 participants with TRD and gave them either 1 mg, 10 mg, or 25 mg COMP360 psilocybin, in conjunction with psychological support from specially trained therapists. Approximately 30% of participants with TRD in the randomized, controlled, double-blind phase 2b study were in remission at week 3 after a single 25 mg dose of COMP360 psilocybin therapy. The difference between the 25 mg group and 1 mg group was -6.6 on the MADRS depression scale at week 3 (p<0.001).
“Over 100 million people around the world suffer with [TRD], and haven’t found relief from existing therapies. With every new treatment, the chance of responding decreases significantly, and patients become even more hopeless. Yet in this study, a substantial number of patients in the 25mg group experienced improvement in their symptoms of depression, with the effects lasting for up to 3 months,” said Scott Aaronson, MD, Chief Science Officer of the Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt Health System, and a principal investigator on the trial.2
Participants who received a 25 mg dose also had double the sustained response at week 12 (20.3%), as compared with those who received 1 mg (10.1%). COMP360 psilocybin was generally well-tolerated; on the day of administration, common adverse events included headache, nausea, and dizziness.
“We saw positive results in a particularly difficult to treat group of patients, and the highest dose of COMP360 psilocybin had the greatest impact on people’s depression. This suggests that COMP360 psilocybin has a true pharmacological effect, a finding that is critical for it to be recognized as a new treatment option in the future,” said Guy Goodwin, MD, DPhil, Chief Medical Officer at COMPASS Pathways. “We look forward to starting our phase 3 program later this year, moving us closer to providing COMP360 psilocybin with psychological support for patients who desperately need it.”
1. Goodwin GM, Aaronson ST, Alvarez O, et al. Single-dose psilocybin for a treatment-resistant episode of major depression. N Engl J Med. 2022;387(18):1637-1648.
2. COMPASS Pathways announces publication of phase 2b study of COMP360 psilocybin therapy for treatment-resistant depression in The New England Journal of Medicine. News release. November 3, 2022. Accessed November 4, 2022. https://compasspathways.com/compass-pathways-announces-publication-of-phase-2b-study-of-comp360-psilocybin-therapy-for-treatment-resistant-depression-in-the-new-england-journal-of-medicine/