Can Psilocybin Help With Treatment-Resistant Depression? COMPASS Pathways Study Shows Promising Results

COMPASS Pathways plc CMPS, a mental health care company, presented positive data from the randomized, controlled, double-blind study of psilocybin therapy, at the American Psychiatric Association annual meeting in New Orleans. The study showed that a single 25mg dose of COMP360 psilocybin, in combination with psychological support, was associated with a highly statistically significant reduction in depressive symptoms after three weeks (p<0.001), with a rapid and durable response for up to 12 weeks.

The randomized, controlled, double-blind phase IIb clinical trial was designed to understand the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg in patients with treatment-resistant depression (TRD). 233 patients with TRD received either 1mg, 10mg or 25mg COMP360 psilocybin, in conjunction with psychological support from specially trained therapists. Symptoms of depression were assessed using the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression; the MADRS assessments were made by an independent, blinded rater.

Key results:

• Depression symptoms: patients who received a 25mg dose of COMP360 psilocybin with psychological support experienced a highly statistically significant reduction in symptoms of depression after three weeks: the difference between 25mg group and 1mg group was -6.6 on the MADRS depression scale at week 3, p<0.001.

• Durability: double the number of patients who received 25mg had a sustained response at week 12, compared to those who received 1mg (20.3% of patients in the 25mg group vs 10.1% in the 1mg group).

• Tolerability: COMP360 psilocybin was generally well-tolerated. On the day of COMP360 administration, headache, nausea, and dizziness were the only adverse events where a dose-related increase in incidence was evident and there were no clinically significant differences between dose group in vital signs or clinical laboratory tests observed during the study.

• Adverse events: In this study suicidal ideation and intentional self-injury were seen in all treatment groups (as is regularly observed in a TRD population), and the majority occurred more than a week after the psilocybin session. There was no mean worsening of suicidal ideation scores in any treatment group. Suicidal behaviors were reported at least 1 month after COMP360 administration for 3 non-responders in the 25mg arm.

David J Hellerstein MD, a principal investigator on the trial and professor of clinical psychiatry at the Columbia University Irving Medical Center, stated: “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. 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.”

Photo: Courtesy of Ahmed Zayan on Unsplash

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