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Trial Shows Psilocybin Drug Helps Reduce Depression

Sad, depressed

(Daniel Reche, Pixabay)

10 Nov. 2021. A clinical trial shows a drug derived from the hallucinogenic compound psilocybin reduces symptoms of depression, when part of a therapy program. Findings from the trial were released yesterday by Compass Pathways plc and not peer-reviewed, which evaluated the company’s drug code-named COMP360 among individuals with depression that had not responded to earlier treatments.

Compass Pathways, based in London, develops treatments for depression and other mental illnesses from psilocybin, an hallucinogenic compound found in so-called magic mushrooms, and considered a controlled substance under drug laws in the U.S. While psilocybin is not naturally addictive, it is used as a recreational drug to generate feelings of euphoria and sensory distortion. The drug can also trigger disturbing hallucinations, panic attacks, and anxiety, and is considered a risk for individuals with a family history of schizophrenia or early onset mental illness.

The company’s lead product is COMP360, a derivative of psilocybin for people with depression that does not respond to current treatments. As noted in Science & Enterprise in December 2019, Compass reported results from an early-stage clinical trial showing COMP360 largely safe and feasible to administer. Results, reported at at a scientific meeting, show participants receiving COMP360 experienced no negative effects on cognitive or emotional functioning, nor any serious adverse effects, but some participants receiving COMP360 reported some psychedelic adverse effects, such as changes in sensory perception and mood.

The newer mid-stage clinical trial enrolled 233 individuals at 25 sites in the U.S., Canada, U.K., and Europe with treatment-resistant depression. Participants were randomly assigned to receive two doses of COMP360 in 25 or 10 milligram capsules, with a 1 milligram dose for comparison. The drug is given as part of therapy sessions, where trained clinicians use psilocybin effects to help patients generate their own observations and insights to change unhelpful behaviors and emotions.

Reduced depression symptoms for several weeks

During an introductory period of three to six weeks, participants were introduced and began weekly therapy sessions with clinicians, as well as discontinued use of any depression medications. Separate evaluators then assessed participants’ symptoms with the standard 10-item Montgomery-Asberg Depression Rating Scale or MADRS, before participants received their COMP360 doses. Evaluators then completed a MADRS test with each participant the next day, and 1, 3, 6, 9, and 12 weeks after receiving the drug.

Results show a rapid decline and fewer depression symptoms among the 25 milligram COMP360 recipients up to 12 weeks after receiving the drug. At each of the testing points up to six weeks following COMP360 doses, the difference in symptom reduction between the 25 and 1 milligram recipients is large enough for statistical reliability. The 10 milligram recipients showed some reduction in symptom reports in the first three weeks, but not enough for statistical reliability. In addition, 24 percent of higher-dose (25 mg) recipients maintained lower depression symptom scores from week 3 to week 12, compared to about 10 percent of lower-dose (10 mg) and 1 milligram recipients, also a statistically reliable difference..

The most common treatment-related adverse effect reported by participants was headache, followed by nausea, fatigue, and insomnia. Compass says more adverse effects were reported by the 25 milligram recipients, although the rate of serious adverse effects, 6 to 8 percent, were similar for the higher- and lower-dose recipients. A total of 12 participants in the trial reported serious effects including suicidal ideation and behavior, and intentional self-injury.

“In this groundbreaking study,” says David Hellerstein, professor of clinical psychiatry at Columbia University and lead researcher on the trial in a Compass Pathways statement, “a single dose of psilocybin, given in conjunction with psychological support, generated a rapid response that lasted up to 12 weeks.” Hellerstein adds, “We now have evidence from a large well-designed trial that psilocybin may be effective for people with treatment-resistant major depressive disorder.”

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