Trial Raises Hope for Psilocybin as Depression Treatment

Regulatory approval could come 'potentially within a few years' time'
By Arden Dier,  Newser Staff
Posted Nov 3, 2022 1:04 PM CDT
Trial Raises Hope for Psilocybin as Depression Treatment
In this Aug. 3, 2007, file photo, psilocybin mushrooms are seen at a farm in Hazerswoude in the Netherlands.   (AP Photo/Peter Dejong, File)

One or two doses of psilocybin, the active ingredient in magic mushrooms, has been found to help people with cancer, alcohol problems, anxiety, and depression, and now those with a severe, treatment-resistant form of depression, according to researchers. A phase 2 randomized, double-blind clinical trial involving 233 people with treatment-resistant depression—meaning they failed to respond to at least two courses of antidepressants—found 37% of those given a single 25-milligram dose of COMP360, a synthetic version of psilocybin, showed immediate improvement. After three weeks, 29% were deemed to be in remission, per CNN.

The participants, who also received talk therapy, were assessed for depression severity, then given a 25-milligram, 10-milligram, or 1-milligram dose of COMP360, resulting in psychedelic trips (monitored by trained therapists) that lasted six to eight hours. Depression severity was then assessed the following day and five more times over 12 weeks. The maximum effect was reportedly seen after a day. "They clearly found a dose effect and clinically meaningful improvement in just three weeks," psychedelics professor Dr. Matthew Johnson of Johns Hopkins, who wasn't involved in the study, tells CNN. "If you were in the 25-milligram group, you were nearly three times as likely to respond than if you were in the 1-milligram group."

Other studies have produced similar results for alcoholics and those struggling with anxiety and depression, including cancer patients. However, the positive effects in those studies often lasted for months. In this study, published Wednesday in the New England Journal of Medicine, "the incidence of sustained response at week 12 was 20% in the 25-mg group, 5% in the 10-mg group, and 10% in the 1-mg group," psychobiologist Dr. Bertha Madras, who was not involved in the study, writes in an accompanying editorial. A small number of participants in all three groups also had suicidal thoughts or harmed themselves during the study period.

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But COMPASS Pathways, the company that produces COMP360 and ran the study, says those behaviors are "common in treatment-resistant depression studies" and "most cases occurred more than a week" after psilocybin was administered, per CNN. Steve Levine, a senior executive at the firm, adds that the results are promising considering this is "a difficult-to-treat population," per NBC News. The outlet reports the company will launch the first phase 3 clinical trial of the drug as a depression treatment, involving 900 people in 14 countries, in December. "That gives us a lot of hope that potentially within a few years' time we could bring this through regulatory approval and hopefully to patients who really need it," says Levine. (More psilocybin mushrooms stories.)

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