Actively Recruiting
Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality
Led by The University of Texas Health Science Center, Houston · Updated on 2025-07-18
10
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
A
Anne and Don Fizer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have completed written informed consent
- Age between 25 and 70 years at screening
- Confirmed diagnosis of Bipolar II Disorder using clinical records and DIAMOND interview
- Suicidality meeting INQ cutoff scores: at least 12 on Perceived Burden and 36 on Thwarted Belongingness subscales
- Depression severity within mild to moderate range (MADRS score 7-34)
- Pass medical examination including physical exam, medical history, ECG, blood tests, psychiatric assessments, and urine drug test
- Willingness to taper down and be off certain mood stabilizers and other relevant medications affecting serotonergic function starting 5 weeks before administration
- Willingness to stop allowed medications at least 24 hours before psilocybin dosing as advised
- Ability to complete all study assessments without assistance and comply with all study visits
You will not qualify if you...
- Do not read or speak English
- Active suicidal ideation with intent or plan (current C-SSRS score of 4 or 5)
- Medically significant suicide attempt in past 6 months
- Current or past Bipolar I disorder, psychotic symptoms or disorders, or serious psychiatric comorbidities impacting safety
- First or second degree relative with Bipolar I disorder or psychotic disorder
- Currently experiencing hypomanic or mixed-symptom episode
- Psychiatric or other conditions incompatible with safe psilocybin exposure
- Personality disorders such as Borderline, Narcissistic, Antisocial, Paranoid, or Schizotypal based on clinical assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77006
Actively Recruiting
Research Team
T
Thomas Meyer, PhD
CONTACT
L
Lauren Vale, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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