Columbia Psychiatry among principal investigators in biotech Compass Pathways study of more than 200 patients
In a groundbreaking study, a single dose of psilocybin, combined with psychological support, generated a rapid response and significant reduction in depressive symptoms that lasted up to 12 weeks.
Compass Pathways, announced that COMP360—a psychedelic compound in magic mushrooms—had succeeded as promising for treatment-resistant depression in a phase 2 clinical trial.
The London-based biotech company partnered on the study with multiple sites, including Columbia University and the New York State Psychiatric Institute.
“We now have evidence from a large, well-designed trial that psilocybin may be effective for people with treatment-resistant major depressive disorder, a common and devastating condition,” said David J. Hellerstein, MD, professor of clinical psychiatry and principal investigator on the Columbia trial. “These findings suggest that COMP360 psilocybin therapy could play a major role in psychiatric care, if approved.”
The study, which has not yet been published in a peer-reviewed journal, is the largest to date using psilocybin to treat depression in people who aren’t helped by existing therapies. An estimated third of severely depressed patients suffer with treatment-resistant depression.
To conduct the research, investigators randomized 233 patients to receive a single dose of one of three doses of COMP360—25 mg, 10 mg, and 1mg, a dose that was essentially a placebo— in conjunction with support from therapists trained to guide people through psychedelic-assisted treatments. All participants were taken off antidepressants before the study.
The study found that participants administered the highest dose of psilocybin had the steepest decline in depressive symptoms. They reported a rapid remission at three weeks that was sustained at the three-month mark. In addition to showing the efficacy of the higher dose, the study showed that the lower dose (10 mg) dose was not effective.
Twenty-four participants withdrew from the trial and some experienced adverse effects. Compass reported that 90 percent of those effects were mild to moderate, most commonly headache, nausea, fatigue, and insomnia. Twelve patients reported severe effects, such suicidal behavior ideation, more common among those with treatment-resistant depression.
Hellerstein said that the study significantly refines our understanding of the required active dose of psilocybin when treating depression, which is an essential step toward reaching the next research phrase.
“This is the first psychedelic study to rigorously evaluate rates of adverse events and serious adverse events, which are of utmost concern when using this powerful class of drugs among patients with severe disorders,” Dr. Hellerstein said. “Understanding these risks is essential to move toward FDA approval and can allow clinicians to develop strategies to manage risks in order to optimize outcomes.”
The company is working toward starting a phase 3 trial of COMP360 in mid-2022.
– Carla Cantor