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Psilocybin Associated With Improved Symptoms in Treatment-Resistant Depression Patients
This week at the American Psychiatric Association’s annual meeting, COMPASS Pathways presented data from a Phase IIb study showing that a single 25-mg dose of its COMP360 psilocybin, administered in combination with psychological support, was associated with a significant reduction in depressive symptoms after 3 weeks, as well as a rapid and durable response for up to 12 weeks.
The study—the largest randomized, clinical, double-blind study of psilocybin on record—was conceived to analyze the efficacy and safety of single, 10-mg and 25-mg doses of the investigational psilocybin compared with 1 mg in patients with treatment-resistant depression (TRD). The study included 233 participants with TRD who received a single dose of psilocybin at 1 of the 3 dosages. All study participants also received psychological support from therapists.
Depression symptoms were measured using the Montgomery-Asberg depression rating scale (MADRS). Findings from the study included. Patients who received 25 mg of psilocybin with psychological support showed a statistically significant reduction in symptoms compared with the 1-mg group. Meanwhile, 20.3% of the 25-mg patients had a sustained response at week 12 compared with 10.1% of 1-mg group.
“Treatment-resistant depression is one of the biggest challenges we face in psychiatry, and chances of success decreases with each treatment that a patient tries,” David J. Hellerstein MD, a principal investigator on the trial and professor of clinical psychiatry at the Columbia University Irving Medical Center, said in a news release. “It’s rare to see such positive outcomes of clinical trials in this disease area, which is why these results are so significant. I hope this represents a major step in finding new options for people living with treatment-resistant depression.”
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