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 via OpenAlex
Summary
AI-generated from the abstractA risk stratification tool is proposed to help decide whether individuals with a family history of bipolar disorder should be included in psilocybin therapy trials. The authors argue for caution due to the potential for serious adverse events, but they recommend against outright exclusion. The tool allows for more nuanced inclusion and exclusion criteria, balancing the need for effective treatments against safety concerns.
Study at a glance
| Characteristics | Theoretical or philosophical paper Peer reviewed |
|---|---|
| Intervention | Psilocybin therapy |
| Topics | Psilocybin |
| Keywords | Bipolar disorder Plea Psychotherapist Psychiatry |
| Citations | 2 |
| Key finding | A risk stratification tool enables nuanced inclusion criteria for psilocybin therapy trials in individuals with a family history of bipolar disorder, balancing 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.