Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive Episodes: A Nonrandomized Open-Label Trial.
Scott T Aaronson, Andrew van der Vaart, Tammy Miller...
https://pubmed.ncbi.nlm.nih.gov/38055270Actively Recruiting
Phase 2
Age: 25Years - 70Years
All Genders
ID06706232
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
N/A
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 trial investigates whether psilocybin combined with psychotherapy is a safe, feasible, and acceptable treatment for adults aged 25 to 70 with Bipolar II depression who experience suicidal thoughts without active plans. This study focuses on reducing suicidality in this population, addressing a critical need as effective treatments for suicidality in Bipolar Disorder remain limited. It is a non-randomized, Phase 2 clinical trial led by The University of Texas Health Science Center, Houston. Participants will receive up to two doses of 25 mg psilocybin, spaced four weeks apart, alongside therapeutic support. The psychological support includes five preparatory psychotherapy sessions before the first dose, a one-hour preparatory session before the optional second dose, and three integration therapy sessions after each dose. The therapy uses a Mindfulness-based CBT approach to help participants process their experiences and apply changes to daily life. Additional therapy sessions are available if participants request more support after the second dose. During the study, participants will complete questionnaires assessing suicidality, depression, and psychiatric symptoms at multiple points, including baseline and several weeks after dosing. Researchers will monitor trial completion rates, therapy attendance, and assessment completion to evaluate feasibility and acceptability. Safety and psychological outcomes will be closely tracked up to 11 weeks after the first dose. The total involvement period includes preparatory, dosing, and follow-up phases to assess the treatment’s impact comprehensively.
CONDITIONS
Brief Title
Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality
Who Can Participate
Age: 25Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Completed written informed consent
- Aged 25 to under 70 years at screening
- Confirmed diagnosis of Bipolar II Disorder using clinical records and structured interviews
- Suicidality meeting specific cutoff scores on Perceived Burden and Thwarted Belongingness scales
- Mild to moderate depression with a Montgomery-Åsberg Depression Rating Scale score between 7 and 34
- Passed medical examination including physical exam, medical history, ECG, blood draw, psychiatric assessments, and urine drug test
- Willingness to taper off mood stabilizers and related medications starting 5 weeks before dosing and remain off medication at least 2 weeks prior to dosing
- Willingness to stop allowed medications at least 24 hours before psilocybin administration
- Ability to complete all study assessments independently and comply with all visits
You will not qualify if you...
- Unable to read or speak English
- Active suicidal ideation with intent or plan (score 4 or 5 on Columbia-Suicide Severity Rating Scale)
- Medically significant suicide attempt within the last 6 months
- History or current diagnosis of Bipolar I disorder, psychotic disorders, or serious psychiatric comorbidities impacting safety or participation
- First or second degree relative with Bipolar I or psychotic disorder
- Currently experiencing hypomanic or mixed-symptom episode
- Psychiatric or other conditions incompatible with safe psilocybin exposure
- Indications of personality disorders such as borderline, narcissistic, antisocial, paranoid, or schizotypal based on clinical interview or judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 5 weeks
Participants taper off mood stabilizers and related medications starting 5 weeks before dosing and remain off medication at least 2 weeks prior to psilocybin administration.
Weekly visits for medication monitoring and psychological support
Treatment
Duration - Up to 11 weeks
Participants receive up to two sequential 25 mg doses of psilocybin with preparatory and integration psychotherapy sessions based on Mindfulness-based CBT.
5 preparatory therapy sessions before first dose, 1 preparatory session before second dose, 3 integration sessions after each dose, and optional additional therapy sessions
Follow-up
Duration - Up to 3 weeks after first administration session and up to 11 weeks after first administration session for those receiving second dose
Participants are monitored for safety, feasibility, and acceptability outcomes after treatment completion.
Multiple assessments and therapy sessions during follow-up period
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77006
Actively Recruiting
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Research Team
T
Thomas Meyer, PhD
L
Lauren Vale, MA
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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Published Research Related To This Trial
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Michael P Bogenschutz, Stephen Ross, Snehal Bhatt...
https://pubmed.ncbi.nlm.nih.gov/36001306Psilocybin with psychological support for treatment-resistant depression: six-month follow-up.
R L Carhart-Harris, M Bolstridge, C M J Day...
https://pubmed.ncbi.nlm.nih.gov/29119217Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial.
Alan K Davis, Frederick S Barrett, Darrick G May...
https://pubmed.ncbi.nlm.nih.gov/33146667Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression.
Guy M Goodwin, Scott T Aaronson, Oscar Alvarez...
https://pubmed.ncbi.nlm.nih.gov/36322843