A collaboration between 34 researchers from 18 institutions analyzed the efficacy and safety of psilocybin in patients with major depressive disorder.
In an article, “Single-dose psilocybin treatment for major depressive disorder: a randomized controlled trial,” published in JAMAthe team found a rapid onset of antidepressant effects, sustained reduction in depressive symptoms, and improvement in psychosocial functioning associated with a single 25 mg dose of psilocybin administered with psychological support in patients with major depressive disorder (MDD).
A randomized, double-blind, placebo-controlled phase 2 trial was conducted at 11 US research sites between December 2019 and June 2022. It enrolled 104 adults diagnosed with MDD with moderate or greater symptom severity.
Participants received a single 25 mg dose of psilocybin or a 100 mg dose of niacin (placebo control) along with psychological support. Primary and secondary outcomes were evaluated at various time points up to 43 days after administration.
Psilocybin treatment was associated with a significant reduction in Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with niacin from baseline to day eight and from baseline to day 43. MADRS is an assessment of 10 items to assess symptoms of depression that address key mood symptoms such as sadness, tension, lassitude, pessimistic thinking, and suicidal thoughts.
Psilocybin treatment also significantly reduced Sheehan Disability Scale (SDS) scores compared to niacin from baseline to day 43. The SDS scale generates scores related to work disability, social disability, and disability. for family life.
Exploratory results included scores on the Clinical Global Impressions Scale, Hamilton Anxiety Rating Scale, Quality of Life Pleasure and Satisfaction Questionnaire, Major Depressive Disorder Symptom Scale, and Oxford Depression Questionnaire (to assess emotional dullness). .
The study found that psilocybin treatment was associated with improvements in these exploratory outcomes, including reductions in global illness severity, self-reported depressive and anxiety symptoms, and improved quality of life. Psilocybin treatment did not lead to emotional blunting, often a side effect of conventional antidepressant medications.
The study suggests that psilocybin treatment had a positive impact on several aspects of mental health and well-being beyond just reducing depressive symptoms, as it improved overall functioning, anxiety symptoms and quality of life for study participants. study.
The unmet need for antidepressants
Currently prescribed antidepressants do not achieve symptom remission in one-third of patients with MDD. For the two-thirds who find the treatment effective, the antidepressant response can take months to manifest, and the average relapse rate within a year of remission is greater than 50%.
This stochastic effectiveness rate often leads physicians to prescribe several different drugs over time in search of a long-lasting response. This strategy inadvertently exposes patients to periods of adaptation to new medications and to withdrawal symptoms from previous treatment attempts.
Most antidepressants are associated with an increase in reports of withdrawal symptoms compared with other drug classes. Stopping antidepressants, even if ineffective, can cause severe and debilitating withdrawal symptoms, including dizziness, nausea, numbness, headache, feeling abnormal, anxiety, suicidal ideation, insomnia, and depression.
Several studies in recent years have suggested that psilocybin causes a rapid antidepressant response that lasts much longer than the presence of the drug in the body and the absence of withdrawal symptoms.
The most recent studies were performed as preliminary trials and require support for a more robust experimental design and larger cohort size. The present study was designed to address these questions using a larger sample size in a randomized, multi-blind design that compared a single dose of psilocybin with an active placebo (niacin) comparator. Blinded raters conducted outcome evaluations to examine timing of onset of action, durability of benefit, and psilocybin’s safety profile over six weeks.
The current study confirms previous efficacy results and reported no treatment-emergent serious adverse events. These findings add to the growing body of evidence suggesting psilocybin as a potential intervention for MDD.
Charles L. Raison et al, Single dose psilocybin treatment for major depressive disorder, JAMA (2023). DOI: 10.1001/jama.2023.14530
Rachel Yehuda et al, Psychedelic Therapy A New Paradigm of Mental Health Care, JAMA (2023). DOI: 10.1001/jama.2023.12900
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