Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial
What does "response without remission" mean for how much better I would actually feel six weeks after a single dose?
Reasonable evidence with real limitations. how we score evidence
Caveat on this rating: Usona is a 501(c)(3), not a commercial company, but it is the sponsor-developer seeking FDA approval of this exact product — scored as industry funding for that reason. Niacin does not mimic psychedelic effects, so unblinding was likely.
Phase 3 complete; rolling NDA under FDA review, final module expected Q4 2026. Breakthrough Therapy designation 2018 (TRD) / 2019 (MDD).
In 104 adults with major depression randomized to a single 25-mg psilocybin dose vs niacin (active placebo), psilocybin produced a significantly greater MADRS reduction through week 6; sustained response — but not higher remission — was observed vs niacin.
Worth asking
What does "response without remission" mean for how much better I would actually feel six weeks after a single dose?
Source
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial — Raison CL, et al. (2023)
Top-tier peer-reviewed journal
Read the source: https://doi.org/10.1001/jama.2023.14530
DOI: 10.1001/jama.2023.14530
How this was scored
- Study design
- Randomised controlled trial
- Funding
- Industry funded
- Published in
- Top-tier peer-reviewed journal
- Sample size
- 104
- Preregistered
- Yes
- Conflicts disclosed
- Yes
- Independent of proponent
- No
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 19, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "moderate evidence". Reasonable evidence with real limitations. It scores 59 out of 100 on our published rubric. One caveat travels with that badge: Usona is a 501(c)(3), not a commercial company, but it is the sponsor-developer seeking FDA approval of this exact product — scored as industry funding for that reason. Niacin does not mimic psychedelic effects, so unblinding was likely. 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 Treatment for Major Depressive Disorder: A Randomized Clinical Trial — Raison CL, et al. (2023). Published in: Top-tier peer-reviewed journal. DOI: 10.1001/jama.2023.14530. 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 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.