Study suggests single dose of psilocybin safe and effective as treatment for major depressive disorder

A collaborative study by 34 investigators at 18 centers investigated the efficacy and safety of psilocybin in patients with major depressive disorder.

In the paper, “Psilocybin single-dose treatment for major depressive disorder: a randomized clinical trial,” JAMAThe research team found that a single dose of 25mg of psilocybin with psychological support in patients with major depressive disorder (MDD) resulted in rapid onset of antidepressant effects, sustained relief of depressive symptoms, and improved psychosocial I found that it works better.

A randomized, double-blind, placebo-controlled Phase 2 study was conducted from December 2019 to June 2022 at 11 US research centers. The trial included 104 adults diagnosed with MDD with moderate or higher symptom severity.

Participants received a single dose of either psilocybin 25 mg or niacin 100 mg (placebo control) along with psychological support. Primary and secondary outcomes were assessed at various time points up to 43 days after dosing.

Psilocybin treatment was associated with significantly lower Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to day 8 and from baseline to day 43 compared with niacin. The MADRS is a 10-item scale for evaluating symptoms of depression, addressing core mood symptoms such as: Sadness, tension, fatigue, pessimistic thoughts, suicidal thoughts, etc.

Psilocybin treatment also significantly reduced Sheehan Disability Scale (SDS) scores compared to niacin from baseline to day 43. The SDS scale produces scores related to work disorders, social disorders, and family disorders.

Exploratory results included the Clinical Global Impression Scale, the Hamilton Anxiety Rating Scale, the Quality of Life Enjoyment and Satisfaction Questionnaire, the Major Depressive Disorder Symptom Scale, and the Oxford Depression Questionnaire (which assesses emotional blunting). ) were included.

This study found that psilocybin treatment was associated with improvements in these exploratory outcomes, including reduced overall disease severity, reduced self-reported depression and anxiety symptoms, and improved quality of life. It turns out. Psilocybin treatment did not lead to the blunted affect commonly seen as a side effect of standard antidepressants.

The study found that psilocybin treatment improved global functioning, anxiety symptoms, and quality of life in study participants, thus not only reducing symptoms of depression but also positively impacting various aspects of mental health and well-being. suggesting that it has influenced

Unmet need for antidepressants

Currently prescribed antidepressants fail to achieve symptom remission in one-third of patients with MDD. Two-thirds of those who respond to treatment take several months to respond to antidepressants, and he has an average relapse rate of more than 50% within one year of remission.

This stochastic efficacy rate often causes clinicians to prescribe several different drugs over time in search of sustained effects. This strategy erroneously exposes patients to periods of adaptation to new drugs and withdrawal symptoms from previous treatment attempts.

Most antidepressants are associated with increased reports of withdrawal syndrome compared with other drugs. Serious and debilitating withdrawal symptoms, such as dizziness, nausea, paresthesias, headaches, abnormal sensations, anxiety, suicidal thoughts, insomnia, and depression, can occur when antidepressants are stopped, even if they are ineffective. there is.

Why psilocybin?

Several recent studies suggest that psilocybin provokes a rapid antidepressant response that lasts much longer than the period in which the drug is present in the body and no withdrawal symptoms are present.

Most of the recent studies have been conducted as preliminary trials and require validation with more robust experimental designs and larger cohort sizes. The current study was designed to address these issues using a larger sample size in a randomized, multi-blind design comparing a single dose of psilocybin to an active placebo comparator (niacin). . Blinded reviewers performed an outcome assessment to examine the timing of onset of action, durability of effect and safety profile of psilocybin over 6 weeks.

The current study confirmed previous findings of efficacy, and no serious adverse events occurred during treatment were reported. These findings contribute to an increasing body of evidence suggesting psilocybin as a potential intervention for MDD.