Psilocybin-assisted psychotherapy for depression and anxiety associated with life threatening illness: A phase 2b randomized controlled trial
Margaret Ross, Ravi Iyer, M.l. Williams, Mark Boughey, Clare O’callaghan, Richard Hiscock, Justin Dwyer
General Hospital Psychiatry August 12, 2025 DOI: 10.1016/j.genhosppsych.2025.08.001 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Population | Individuals with a life-threatening illness |
| Intervention | Psilocybin-assisted psychotherapy |
| Topics | Anxiety Psilocybin Depression Psychedelic-assisted therapy |
| Keywords | Randomized controlled trial Psychotherapist Depression economics Clinical psychology Hallucinogen |
| Citations | 13 |
| Key findings | Psilocybin-assisted psychotherapy appears safe and may offer durable relief from depression and anxiety in individuals with a life-threatening illness. |
Abstract
Psilocybin-assisted psychotherapy appears safe and may offer durable relief from depression and anxiety in individuals with a life-threatening illness.
Comparable studies
Other randomized controlled trials on psilocybin and psychedelic-assisted therapy, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Psilocybin occasioned mystical-type experiences: immediate and persisting dose-related effects. Healthy adults, mostly hallucinogen-naïve | 2011 | Randomized controlled trial | n = 18 |
| Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder Adults aged 25–65 with DSM-IV alcohol dependence and at least 4 heavy drinking days in... | 2022 | Randomized controlled trial | n = 95 |
| Increased global integration in the brain after psilocybin therapy for depression. Patients with treatment-resistant depression and patients with major depressive disorder | 2022 | Open-label trial and double-blind phase II randomized controlled trial | |
| Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. Adults diagnosed with major depressive disorder and no unstable somatic conditions | 2023 | Double-blind, randomised clinical trial | n = 52 |
| Implications for psychedelic-assisted psychotherapy: functional magnetic resonance imaging study with psilocybin Healthy participants | 2012 | Randomized controlled trial | n = 10 |
Citations in the library
Cited by 14
- Stepping back into life: How Psychedelic Assisted Psychotherapy transforms the way of life of the terminally ill General Hospital Psychiatry December 10, 2025
- A living systematic review, meta-analysis and open-data resource of randomized controlled trials of psilocybin treatment for symptoms of depression Nature Mental Health May 1, 2026
- Mind-Body Interventions for People With Cancer: Evidence, Innovation, and Implementation. Seminars in radiation oncology July 1, 2026
- Implementing psilocybin-assisted therapy in palliative care settings: A survey of stakeholders Palliative Medicine May 19, 2026
- Psychedelic therapy and cultural humility Translational Psychiatry February 27, 2026
and 9 more in the library
Cites 12
- Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Journal of Psychopharmacology November 30, 2016
- Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Journal of Psychopharmacology November 30, 2016
- Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance Psychopharmacology July 7, 2006
- Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder JAMA Psychiatry November 4, 2020
- Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer Archives of General Psychiatry September 7, 2010
and 7 more in the library