RecruitingPhase 2NCT06706232

Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

10 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Bipolar II Disorder

Summary

The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression.

Eligibility

Min Age: 25 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether two doses of psilocybin (the active compound in psychedelic mushrooms) are safe and acceptable for treating depression and passive suicidal thinking in people with Bipolar II Disorder. **You may be eligible if...** - You are between 25 and 70 years old - You have a confirmed diagnosis of Bipolar II Disorder - You currently have mild to moderate depression (MADRS score of 7-34) - You are experiencing passive suicidal thinking based on specific questionnaire scores (feeling like a burden or disconnected from others) - You pass a medical screening to ensure psilocybin is safe for you **You may NOT be eligible if...** - You have Bipolar I Disorder or a history of mania or psychosis - You have active or severe suicidal intent with a plan - You have medical conditions that make psilocybin unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

Two sequential administrations of 25 mg psilocybin, 4 weeks apart.

BEHAVIORALTherapeutic Support

Five preparatory in-person psychotherapy sessions will be offered before the first administration session during weeks 1, 2, 3, 4, and 5. The optional second administration session will be preceded by a shorter 60 min preparatory session the day before. Each administration session will be followed by 3 integration sessions and will adopt a Mindfulness-based CBT approach (M-CBT), in which a therapist will help the participant to process their experience and how to translate this into actual changes in everyday life. If participants prefer more psychological support after the second administration session, they will be offered additional, optional therapy sessions for the duration of the trial regardless if they opted for a second administration session or not.