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96. An Open Label Study of Synthetic Psilocybin in Bipolar Type II Depression

Scott T Aaronson, Tammy Miller, Samuel Rudow, MacKenzie Forbes, Audrey Shoultz, Trisha Suppes

Biological Psychiatry May 1, 2023 DOI: 10.1016/j.biopsych.2023.02.336 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Observational cohort Open-label Peer reviewed
Sample size 38
Population Individuals meeting criteria for clinical high-risk for psychosis (CHR-P), mean age 19.3, treated in a specialized outpatient program
Duration 26 weeks
Topics Depression Psilocybin
Key findings Attenuated psychotic symptoms decreased among all participants during 26 weeks of step-based care, while functioning did not change significantly overall. Participants with more psychiatric comorbidities at baseline showed improved functioning over time relative to those with fewer comorbidities, suggesting clinical complexity may predict functional response.

Abstract

Background: Despite increasingly re fi ned tools for identi-fying individuals at clinical high-risk for psychosis (CHR-P), less is known about the effectiveness of interventions for CHR-P. The signi fi cant clinical heterogeneity among CHR-P individuals is a notable barrier, suggesting that interventions may need to be personalized during this emerging phase of illness. To address these gaps, the current study examined two questions: (1) how do symptoms and functioning change in response to novel, personalized step-based intervention for CHR-P, and (2) how do baseline clinical and demographic factors in fl uence response to step-based care?

Methods: 38 individuals meeting CHR-P criteria (mean age ¼ 19.3) were rated by clinicians on attenuated psychotic symptoms and functioning at baseline and each week during 26 weeks of novel step-based care for CHR-P delivered in a specialized outpatient program. Linear mixed-effects models examined change over time in symptoms and functioning, and tested the effect of baseline covariates.

Results: Mixed-effects models found that attenuated psychotic symptoms decreased during the study period, while functioning did not signi fi cantly change. When examining baseline clinical and demographic factors as predictors of treatment response, a signi fi cant group by time interaction emerged whereby CHR-P individuals with more psychiatric comorbidities at baseline (indicating greater clinical complexity) improved in functioning during the study period relative to CHR-P individuals with fewer psychiatric comorbidities.

Conclusions: Attenuated psychotic symptoms decreased among all participants receiving outpatient step-based care. Individual differences in clinical complexity may predict functional response during the early phases of CHR-P treatment.

Comparable studies

Other observational and cohort studies on psilocybin for depression, most cited first.

Study Year Design Participants
Psilocybin for treatment-resistant depression: fMRI-measured brain mechanisms. Patients with treatment-resistant depression 2017 Observational cohort n = 19
Psilocybin with psychological support improves emotional face recognition in treatment-resistant depression Patients with treatment-resistant depression and healthy controls 2017 Observational cohort n = 33
More Realistic Forecasting of Future Life Events After Psilocybin for Treatment-Resistant Depression Patients with treatment-resistant depression (TRD) 2018 Observational cohort n = 15
Natural speech algorithm applied to baseline interview data can predict which patients will respond to psilocybin for treatment-resistant depression. 17 patients with treatment-resistant depression and 18 untreated age-matched healthy... 2018 Observational cohort with machine learning classification n = 35
Brain dynamics predictive of response to psilocybin for treatment-resistant depression. Responders and non-responders to psilocybin therapy for depression 2024 Observational cohort

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