Reductions in anxiety, depression in cancer-related psychiatric distress sustained at 3.2 and 4.5 years.
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The FDA has granted Breakthrough Therapy designation to psilocybin for the treatment of major depressive disorder.
The designation was granted to COMPASS Pathways, a life sciences company investigating psilocybin in a Phase 2b trial involving 216 patients at multiple sites across Europe and North America.
Currently, psilocybin, a serotonin receptor agonist, is classified as a Schedule I agent as it has not been approved by the Food and Drug Administration (FDA) for any therapeutic use.
The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America.
A single moderate-dose of psilocybin (a hallucinogenic compound contained in psychedelic mushrooms) was found to produce enduring anxiolytic and antidepressant effects in distressed cancer patients with life-threatening diagnoses.
According to a study in The American Journal of Drug and Alcohol Abuse, psilocybin showed promise in promoting long-term smoking abstinence in the context of a structured treatment program.
Results from a recent study published in The Lancet Psychiatry demonstrates preliminary support for the safety and efficacy of the hallucinogenic compound, psilocybin, for the management of treatment-resistant depression.
A single dose of psilocybin can alleviate negative moods in patients with life-threatening cancer, a new study has found.
A new study in the Journal of Psychopharmacology has found that use of psychedelic drugs such as lysergic acid diethylamide (LSD) and psilocybin (magic mushrooms) does not increase a person’s risk of developing mental health problems such as depression and suicidal thoughts.