CLEVELAND — Long known as a recreational drug, the component in "magic mushrooms" known as psilocybin, has been studied for nearly two decades to help those with mental health disorders.
The treatment occurs in academic medical settings in combination with psychotherapy for treating addiction, depression and other mood disorders.
Psilocybin acts on serotonin in the brain to affect mood, cognition, and perception. It is a naturally occurring compound produced by more than 200 types of fungi species.
Cleveland Clinic is now part of a multisite trial with over 50 sites researching this drug to treat treatment-resistant depression.
Patients participating in the research will ingest either psilocybin or placebo in capsule form. They will be randomized to receive one of three psilocybin doses and monitored for at least six hours on psilocybin administration days by a psychedelic-assisted therapist.
Participants will receive psilocybin at least twice. They will be followed for 52 weeks after the initial dose.
"We don't have a set number of participants that we're looking for, so we're we're hoping to enroll quite a few patients in this," said Dr. Brian Barnett, Cleveland Clinic Psychiatrist at the Center for Adult Behavioral Health at Lutheran hospital.
To qualify for the study, Dr. Barnett says patients must have a diagnosis of treatment-resistant depression and tried between two and four medications for their depression during the current episode of depression.
For safety reasons, there are conditions that would cause exclusion from the study. They include people who have a diagnosis of bipolar disorder, schizophrenia which includes those with family members or close family members with a history of bipolar or psychotic disorder.
Also, the patient cannot have had an active alcohol or other substance-use disorder within the last year or any recent issues with suicidal thoughts.
Also disqualified are patients who tried other non-pharmacological modalities such as electroconvulsive therapy, vagal nerve stimulator, or deep brain stimulator.
Results so far have indicated that psilocybin may be successful in treating depression and treatment-resistant depression with psychological support.
Last year, Cleveland Clinic launched its first psychedelic trial for patients with generalized anxiety disorder. Participants received a one time dose of MindMed's proprietary LSD formulation (one of four different doses) or placebo.
Participants’ anxiety scores were assessed 4 weeks later to assess efficacy and determine the optimal dose for future clinical trials of LSD for generalized anxiety disorder. This trial has concluded and topline data have been publicly reported by MindMed.
For more information on the psilocybin study call 216-425-7426.
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