Psilocybin
Checked Oct 11, 2026 · 13 sources checked
Psilocybin is the main psychedelic compound in so-called magic mushrooms. In the US it is a Schedule I controlled substance, and no psilocybin medicine is FDA-approved. Researchers are testing it, with psychological support, for depression that other treatments have not helped. Compass Pathways says two phase 3 trials of its synthetic psilocybin were positive. These results come from the company and are not yet peer-reviewed. The company expects to finish its application for FDA approval in late 2026. Any US launch would also need the DEA to reclassify the approved drug. Common short-term side effects in trials include headache, nausea and dizziness. Suicidal thoughts and self-harm were also reported, and rare lasting changes in perception have occurred. Oregon licenses supervised psilocybin services under state law. That is not FDA approval, and federal law still lists psilocybin in Schedule I.
Education only, not medical advice. Talk to a clinician about your own situation.
Attention and coverage on this topic — not proof. Receipts below.
The Washington Post · Sep 17, 2026
Axios · Sep 16, 2026
The New York Times · Sep 3, 2026
Very high, steady interest. In September 2026 English Wikipedia's Psilocybin and Psilocybin mushroom articles had 40,762 and 49,701 views. PubMed added 49 psilocybin records in the 30 days to Oct 11 2026. A pending FDA filing adds news attention (company-reported timeline). Federal attention is also rising: an April 2026 executive order set a policy to speed research on and access to psychedelic drugs, and the FDA held a public hearing on their possible future therapeutic use on September 14, 2026.
In 233 adults with treatment-resistant depression, the highest of three single psilocybin doses lowered depression scores more than a very low control dose at week 3 (difference 6.6 points); the middle dose did not. Suicidal ideation, behavior or self-injury occurred in all groups.
For adults with treatment-resistant depression, does psilocybin keep working for months, and how does it compare with standard care?
If peer-reviewed COMP005/COMP006 results confirm the company-reported effects and durability, we would upgrade the opening from "being tested" to "shown in phase 3".
If FDA approves a psilocybin product and DEA reschedules it, we would update the legal-status sentence on the same day.
If blinded or active-controlled trials show much smaller effects, we would say expectation explains part of the earlier results.
Word on the street
Who's covering it lately. Coverage means people are talking about it; it isn't evidence, and it never changes our read.
- The Washington Post · Sep 17, 2026Read the coverage ↗
- Axios · Sep 16, 2026Read the coverage ↗
- The New York Times · Sep 3, 2026Read the coverage ↗
- NPR · Aug 19, 2026Read the coverage ↗
For the pros: claims, studies and receipts13 sources · tap to open
5 reviewed claim records · 13 linked source receipts Inspect source receipts
Maturity: source checked
In 233 adults with treatment-resistant depression, the highest of three single psilocybin doses lowered depression scores more than a very low control dose at week 3 (difference 6.6 points); the middle dose did not. Suicidal ideation, behavior or self-injury occurred in all groups.
Adults with treatment-resistant depression (multinational) · Outcome: MADRS change at week 3Confidence applies to this claim and context.
Checked facts
- In 233 adults with treatment-resistant depression, the highest of three single psilocybin doses lowered depression scores more than a very low control dose at week 3 (difference 6.6 points); the middle dose did not. Suicidal ideation, behavior or self-injury occurred in all groups. PMID 36322843 ↗
- A meta-analysis of 17 depression trials found that control groups improved less in psilocybin trials than in SSRI or esketamine trials, which may make psilocybin look more effective than it is. PMID 40736734 ↗
- In 104 adults with major depressive disorder, a single psilocybin dose lowered depression scores more than an active placebo (niacin) by day 43 (difference 12.3 points). There were no serious treatment-related adverse events, but overall and severe adverse events were more common with psilocybin. PMID 37651119 ↗
- In 59 adults with moderate-to-severe depression, psilocybin was not significantly better than the antidepressant escitalopram on the main depression measure at week 6 (difference 2.0 points, P = 0.17). Secondary measures favored psilocybin but were not corrected for multiple comparisons. PMID 33852780 ↗
- In a German trial of 144 adults with treatment-resistant depression, one high-dose psilocybin session with psychotherapy did not significantly increase response at week 6 compared with an active placebo (nicotinamide) (17.0% vs 10.6%). Suicidal thoughts on dosing days were more common with psilocybin (4% vs 1–2%), and one person developed lasting perceptual disturbances (hallucinogen persisting perception disorder). PMID 41848690 ↗
Attention describes reviewed public attention, evidence shows study types, and confidence applies only to the stated claim. There is no overall score.
Claims
Would change this claim: If peer-reviewed COMP005/COMP006 results confirm the company-reported effects and durability, we would upgrade the opening from "being tested" to "shown in phase 3".
Source: Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. · PMID 36322843 · N Engl J Med · Abstract, Results: difference -6.6 (95% CI -10.2 to -2.9) highest vs control; -2.5 (-6.2 to 1.2) middle dose; AEs in 179/233 (77%); suicidal ideation/behavior/self-injury in all dose groups · Verify ↗Source: The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression · NCT NCT03775200 · COMPASS Pathways · Abstract, Results: difference -6.6 (95% CI -10.2 to -2.9) highest vs control; -2.5 (-6.2 to 1.2) middle dose; AEs in 179/233 (77%); suicidal ideation/behavior/self-injury in all dose groups · Verify ↗Mapped studies / experiment families
One experiment counts once, even with several registrations or publications. Counts above describe the headline claim.
No reviewed experiment families mapped yet.
Studies & active trials
Only papers and registered trials an editor reviewed for this page. Being listed is not a finding; the claims above say what they show.
What still isn't settled?
For adults with treatment-resistant depression, does psilocybin keep working for months, and how does it compare with standard care?
Peer-reviewed trials lasted 3 to 6 weeks for their main result. Compass reports 26-week phase 3 data, but these are company-reported and not peer-reviewed. The second phase 3 trial is still active.
What would answer it: Peer-reviewed publication of the COMP005 (NCT05624268) and COMP006 (NCT05711940) phase 3 results, and the VA PIVOT trial (NCT07226232; 240 veterans; est. 2030-12).
In phase 2 randomized trials, a single psilocybin session with psychological support usually lowered depression scores more than a very low dose or an active placebo over 3 to 6 weeks, but a 2026 trial of 144 people missed its main goal. Against a standard antidepressant (escitalopram), it was not clearly better on the main measure. Trials are hard to blind because people can tell they got the drug. Peer-reviewed phase 3 results are not yet published.