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Psychedelic Depression Drug Tested for Safety

Psilocybe aztecorum

Psilocybe aztecorum, also known as “magic mushrooms,” the source of psilocybin (Alan Rockefeller, Wikimedia Commons)

12 Dec. 2019. Results from an early clinical trial testing an hallucinogenic drug to treat depression shows the therapy is largely safe and feasible to administer. Findings from the trial testing the treatment code-named COMP360 by Compass Pathways in London were reported yesterday at a meeting of American College of Neuropsychopharmacology in Orlando, Florida.

Compass Pathways 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.

COMP360 is a derivative of psilocybin for people with depression that does not respond to current treatments. Compass Pathways was founded in 2016 by physician and medical researcher Ekaterina Malievskaia and technology entrepreneur George Goldsmith, a wife and husband team who experienced dealing with depression in a family member. Development of psilocybin into a treatment for depression is based on earlier research with the substance in the U.S. at Johns Hopkins University, New York University, and UCLA, as well as institutions in the U.K. and Switzerland. In October 2018, FDA designated COMP360 as a breakthrough therapy for treatment-resistant depression.

In the conference paper, Compass Pathways reported on an early-stage study of COMP360 at King’s College London with 89 participants evaluating its safety and feasibility factors with healthy adult volunteers. The study was led by researcher James Rucker in the Kings College department of psychological medicine that conducts trials of psilocybin.

In this trial, volunteers were randomly assigned to receive COMP360 in doses of 10 or 25 milligrams, or a placebo, followed by support in up to six simultaneous groups from trained clinicians for about six hours. The company says results show participants receiving COMP360 experienced no negative effects on cognitive or emotional functioning, nor any serious adverse effects. Individuals receiving COMP360 report some psychedelic adverse effects, such as changes in sensory perception and mood. The study team also says COMP360 can be feasibly administered in controlled settings, such as the group sessions used in the trial.

“This is the largest controlled study of psilocybin to date,” says Rucker in a company statement issued through PR Newswire. “The results of the study are clinically reassuring and support further development of psilocybin as a treatment for patients with mental health problems that haven’t improved with conventional therapy, such as treatment resistant depression.”

Compass Pathways also has a mid-stage clinical trial of COMP360 underway enrolling 216 participants in the U.S. and Europe with treatment-resistant depression. The trial is looking primarily at indicators of the drug’s safety, as well as scores by patients on a standard rating scale of depression symptoms from clinicians.

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