On blinding and suicide risk in a recent trial of psilocybin-assisted therapy for treatment-resistant depression.
Med January 13, 2023 DOI: 10.1016/j.medj.2022.12.003 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Phase II trial Peer reviewed |
|---|---|
| Population | People with treatment-resistant depression |
| Intervention | Psilocybin-assisted therapy |
| Topics | Psychedelic-assisted therapy Depression Psilocybin |
| Keywords | Mental health treatment Depression research Clinical trials Drug safety |
| Citations | 12 |
| Key findings | Psilocybin-assisted therapy showed modest efficacy for treatment-resistant depression but raised concerns about serious adverse effects. |
Abstract
Results from a recent Phase II trial of psilocybin-assisted therapy for treatment-resistant depression1 suggest modest efficacy but raise concerns about potential for serious adverse effects. The study highlights the need for rigorous assessment of blinding integrity, expectancy, and further study of factors that may contribute to risk in vulnerable populations.
Comparable studies
Other non-randomized and open-label trials on psilocybin and psychedelic-assisted therapy, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Patients with severe, unipolar, treatment-resistant major depression | 2017 | Open-label trial | n = 20 |
| Psilocybin therapy increases cognitive and neural flexibility in patients with major depressive disorder. Patients with major depressive disorder | 2021 | Open-label study | n = 24 |
| HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. Cancer patients with a DSM-5 depressive disorder (major depressive disorder or... | 2023 | Open-label feasibility and safety pilot study | n = 12 |
| Group psychedelic therapy: empirical estimates of cost-savings and improved access Adults with PTSD or major depressive disorder eligible for psychedelic-assisted therapy... | 2023 | Comparative cost analysis using trial data and published estimates | |
| Increased low-frequency brain responses to music after psilocybin therapy for depression. Patients with treatment-resistant depression | 2023 | Open-label trial | n = 19 |
Citations in the library
Cited by 11
- Transformative experience and informed consent to psychedelic-assisted psychotherapy Frontiers in Psychology May 26, 2023
- Mechanisms and molecular targets surrounding the potential therapeutic effects of psychedelics. Molecular Psychiatry September 1, 2023
- Psilocybin for the treatment of Alzheimer’s disease Frontiers in Neuroscience July 10, 2024
- Psychedelic group-based integration: ethical assessment and initial recommendations International Review of Psychiatry June 5, 2024
- Psychedelic Use Among Psychiatric Medication Prescribers: Effects on Well-Being, Depression, Anxiety, and Associations with Patterns of Use, Reported Harms, and Transformative Mental States. Psychedelic Medicine September 1, 2023
and 6 more in the library
Cites 6
- Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder JAMA Psychiatry November 4, 2020
- Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. New England Journal of Medicine November 3, 2022
- Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology November 8, 2017
- Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder JAMA Psychiatry August 24, 2022
- Blinding and expectancy confounds in psychedelic randomized controlled trials Expert Review of Clinical Pharmacology May 26, 2021
and 1 more in the library