Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression
How durable is a single-dose response, and what monitoring is planned for suicidality in the weeks after dosing?
Reasonable evidence with real limitations. how we score evidence
Caveat on this rating: Sponsor-run trial by the company seeking FDA approval; benefit at week 3 faded for many by week 12 (sustained response was a minority outcome in the full paper).
Phase 3 complete; rolling NDA under FDA review, final module expected Q4 2026. Breakthrough Therapy designation 2018 (TRD) / 2019 (MDD).
In 233 adults with treatment-resistant depression (phase 2b), a single 25-mg dose of COMP360 reduced MADRS scores at week 3 by 12.0 points vs 5.4 with a 1-mg control (−6.6 difference); the 10-mg dose was not significantly better than control, adverse events occurred in 77% of the 25-mg group, and suicidal ideation or self-injurious behavior was seen in all dose groups.
Worth asking
How durable is a single-dose response, and what monitoring is planned for suicidality in the weeks after dosing?
Source
Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression — Goodwin GM, et al. (2022)
Top-tier peer-reviewed journal
Read the source: https://doi.org/10.1056/NEJMoa2206443
DOI: 10.1056/NEJMoa2206443
How this was scored
- Study design
- Randomised controlled trial
- Funding
- Industry funded
- Published in
- Top-tier peer-reviewed journal
- Sample size
- 233
- Preregistered
- Yes
- Conflicts disclosed
- not recorded
- Independent of proponent
- No
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 19, 2026.
Where we put this study in context
Questions
How strong is the evidence behind this?
Resolv rates this source "moderate evidence". Reasonable evidence with real limitations. It scores 55 out of 100 on our published rubric. One caveat travels with that badge: Sponsor-run trial by the company seeking FDA approval; benefit at week 3 faded for many by week 12 (sustained response was a minority outcome in the full paper). The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression — Goodwin GM, et al. (2022). Published in: Top-tier peer-reviewed journal. DOI: 10.1056/NEJMoa2206443. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Randomised controlled trial. Funding: Industry funded. The researchers were not independent of whoever benefits from the result. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is psilocybin, comp360 FDA approved for this use?
No. Its current status is: Phase 3 trials. Phase 3 complete; rolling NDA under FDA review, final module expected Q4 2026. Breakthrough Therapy designation 2018 (TRD) / 2019 (MDD).
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.