A Plea for Nuance: Should People with a Family History of Bipolar Disorder Be Excluded from Clinical Trials of Psilocybin Therapy?
Joshua Woolley, Amanda E. Downey, Ellen Bradley, Anna Skovgaard Lerche, Aoife O’donovan, Andrew D. Krystal
Psychedelic Medicine February 28, 2024 DOI: 10.1089/psymed.2023.0051 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Theoretical or philosophical paper Peer reviewed |
|---|---|
| Intervention | Psilocybin therapy |
| Topics | Psilocybin |
| Keywords | Bipolar disorder Plea Psychotherapist Family therapy Clinical trial |
| Citations | 2 |
| Key points | Argues that individuals with a family history of bipolar disorder should not be outright excluded from psilocybin therapy trials, but rather assessed with a risk stratification tool to balance treatment benefits against potential adverse events. |
Abstract
Balancing the need for effective treatments against the potential for serious adverse events in those undergoing psilocybin therapy with a family history of BD, we argue for caution in psychedelic clinical trials but not outright exclusion of these individuals. Our risk stratification tool allows for more nuanced inclusion and exclusion criteria.
Comparable studies
Other theoretical and historical papers on psilocybin, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| REBUS and the Anarchic Brain: Toward a Unified Model of the Brain Action of Psychedelics | 2019 | Theoretical or philosophical paper | |
| Psychedelics as Medicines: An Emerging New Paradigm General population | 2016 | Theoretical or philosophical paper | |
| Theorizing that Psychedelic Assisted Therapy May Play a Role in the Treatment of Trauma-Induced Personality Disorders. | 2024 | Theoretical or philosophical paper | |
| What Geometric Visual Hallucinations Tell Us about the Visual Cortex | 2002 | Theoretical or philosophical paper | |
| Psilocybin-assisted therapy of major depressive disorder using Acceptance and Commitment Therapy as a therapeutic frame | 2020 | Theoretical or philosophical paper |
Citations in the library
Cited by 4
- Reported Safety Practices of Publicly Advertised Psychedelic Retreats. JAMA Network Open January 2, 2026
- Multilevel Mechanisms and Clinical Efficacy of Psilocybin in Depression Treatment: A Systematic Review International Journal of Molecular Sciences September 10, 2026
- Psychedelic-induced hypomania and mania: a systematic review and meta-analysis. Molecular Psychiatry May 29, 2026
- Medical and Psychiatric Consultation for Patients Considering State-Regulated Psilocybin Services: A Risk-Reduction Model and Two Illustrative Cases
Cites 36
- 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 with psychological support for treatment-resistant depression: an open-label feasibility study. The Lancet Psychiatry May 17, 2016
- Trial of Psilocybin versus Escitalopram for Depression New England Journal of Medicine April 14, 2021
- Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder JAMA Psychiatry November 4, 2020
and 31 more in the library