Loading
Bipolar Depression / Psilocybin / Functional MRI · Phase 1 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 registry record for an active, uncontrolled proof-of-concept study examining the neurobiological mechanism (amygdala activity on fMRI) by which a single 25 mg oral psilocybin dose may produce antidepressant effects in treatment-resistant bipolar depression. No results have been posted; the study is designed to generate mechanistic hypothesis data in a small cohort rather than establish efficacy.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Bipolar Depression; age from 18 Years; to 65 Years. Intervention: Single Dose Psilocybin. n = 30. 1 site: Canada.
This is a Phase 1 registry record for an active, uncontrolled proof-of-concept study examining the neurobiological mechanism (amygdala activity on fMRI) by which a single 25 mg oral psilocybin dose may produce antidepressant effects in treatment-resistant bipolar depression. No results have been posted; the study is designed to generate mechanistic hypothesis data in a small cohort rather than establish efficacy.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This is a mechanisms-of-action study, not a clinical efficacy trial. Clinicians should not interpret this as evidence of benefit; results, if posted, will inform hypotheses about how psilocybin might work neurobiologically in bipolar depression, potentially justifying larger controlled trials.
This is an active Phase 1 proof-of-concept study with no results yet reported; it aims to characterize neurobiological mechanisms in a small, uncontrolled cohort rather than establish clinical efficacy.
As stated by the source record.
Quoted from the source exactly as published.
This is a mechanisms-of-action study, not a clinical efficacy trial. Clinicians should not interpret this as evidence of benefit; results, if posted, will inform hypotheses about how psilocybin might work neurobiologically in bipolar depression, potentially justifying larger controlled trials.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06506019). This is a study registration, not published results. Lead sponsor: University Health Network, Toronto. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Bipolar Depression. Interventions: DRUG: Psilocybin; DEVICE: Functional MRI. Primary outcome measures: Correlation of Amygdala Activity on fMRI with MADRS Score , Baseline to 1 and 4 weeks post psilocybin dosing; Change in Depression Symptoms , Baseline to 4 weeks post psilocybin dosing; Clinical Global Impressions Scale (CGI) , Baseline to 1 week post psilocybin dosing; Study Recruitment and Retention Rates , Washout period to 4 week post psilocybin dosing. Brief summary: This study is an open-label, single-arm, proof-of-concept study, wherein treatment resistant bipolar depression (TRBD) participants will receive one 25 mg dose of oral psilocybin accompanied by preparatory, monitoring, and integration psychotherapy sessions (psilocybin-assisted psychotherapy, or PAP). Using fMRI (functional magnetic resonance imaging), the findings of this study will provide data on the neurobiological mechanism of psilocybin in TRBD. The primary objective is to understand the dynamic role of amygdala activity by evaluating the neurobiological effects of a single psychedelic dose (25 mg) of oral psilocybin in individuals with a moderate to severe major depressive episode and a primary diagnosis of Bipolar II Disorder, with 2 or more failed treatment trials (i.e., treatment resistant bipolar depression \[TRBD\]). Neurobiological effects will be determined by evaluating the association between post-treatment right amygdala activity during the facial affect task (determined by fMRI one day after the psilocybin dose) and antidepressant effects (determined by changes in the Montgomery-Åsberg Depression Rating Scale \[MADRS\] scores over time, during the one-week period post-psilocybin dose). This is a single-arm, open-label clinical trial wherein all participants will receive the same study intervention. Hypothesis: Increased right amygdala activity on fMRI with emotional stimuli one day after psilocybin treatment will be associated with greater antidepressant effects in the one-week period post-treatment in individuals with TRBD.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.