Psilocybin for major depressive disorder: a systematic review of randomized controlled studies.
Study Goal
The researchers aimed to evaluate the effectiveness, safety, and tolerability of psilocybin in treating major depressive disorder (MDD) in adults through a systematic review of randomized controlled trials.
Results Summary
Psilocybin showed beneficial effects on depressive symptoms in 60% of the included studies and significantly improved anxiety symptoms in 80% of the studies assessing this outcome. Discontinuation rates and adverse drug reactions were similar between psilocybin and control groups, with headache being the most common adverse reaction.
Population
Physically healthy adult patients with major depressive disorder (MDD).
Effective Dosage
Not specified in the abstract.
Duration
Not specified in the abstract.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
psilocybin | increase | MDD treatment | adult patients with MDD | in three out of five RCTs (60%) | had a beneficial effect | #1 |
psilocybin | increase | anxiety symptoms | patients with MDD | in four out of five RCTs (80%) | was significantly more effective | #2 |
psilocybin | increase | suicidal ideation | patients with MDD | in one out of five RCTs | was more effective | #3 |
psilocybin | no change | discontinuation rates for any reason | adult patients with MDD | psilocybin group (2-13%) vs control group (4-21%) | were similar | #4 |
psilocybin | increase | depressive symptoms | patients with MDD | in over half of the included studies | was effective in improving | #5 |
psilocybin | decrease | anxiety symptoms | patients with MDD | - | reduced | #6 |
OBJECTIVES: The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the effectiveness, safety, and tolerability of psilocybin in adult patients with major depressive disorder (MDD). METHODS: A systematic search (up to September 14, 2023) was conducted for RCTs that examined the efficacy, safety, and tolerability of psilocybin in physically healthy adult patients with MDD. Three independent researchers extracted data from publications where the primary outcome was a change in depressive symptoms, and key secondary outcomes were changes in anxiety symptoms and suicidal ideation, discontinuation rates for any reason, and adverse drug reactions (ADRs). RESULTS: Five RCTs with 472 adult patients with MDD on psilocybin (n = 274) and controls (n = 198) were included. Two of the five RCTs (40%) reported mixed results, while the other three (60%) found that psilocybin had a beneficial effect on MDD treatment. Four RCTs (80%) assessing the anxiolytic effects of psilocybin for treating MDD found that psilocybin was significantly more effective than the control group in improving anxiety symptoms. Psilocybin was more effective than the control group in improving suicidal ideation in one out of five RCTs. Discontinuation rates were similar for any reason between the psilocybin group (2-13%) and the control group (4-21%) (P > 0.05). Four RCTs (80%) reported ADRs in detail. The most common ADR in both groups was headache. CONCLUSION: Psilocybin was effective in improving depressive symptoms in over half of the included studies and reduced anxiety symptoms in patients with MDD. The long-term efficacy and safety of psilocybin for MDD treatment needs to be further investigated in large RCTs.