RecruitingPhase 2

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

United States10 participantsStarted 2025-07-07

Plain-language 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.

Who can participate

Age range

25 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must have completed written informed consent * Must be at 25 years of age or older at screening (but below age of 70) * Confirmed Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of BD-II using clinical records and Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive disorder (OCD) and Related Neuropsychiatric Disorders (DIAMOND) * Must meet criteria for suicidality according to the INQ cutoff scores: A score of at least 12 on the Perceived Burden (PB) subscale and at least a score of 36 on the Thwarted Belongingness (TB) subscale indicating substantial risk for passive suicidal ideation * Must meet criteria for depression according to the MADRS cutoff scores: A score of 7-34 indicating mild to moderate depression * Must pass medical examination (physical exam, personal/family medical history, including consultation with current medical provider, ECG, about 4 tablespoons blood draw, psychiatric/psychological assessments, urine drug test) * Willingness to taper down mood stabilizers and other relevant medications (including but not limited to: antidepressants, antipsychotics, lithium, benzodiazepines, Monoamine oxidase inhibitors (MAOIs), Selective serotonin reuptake inhibitors (SSRIs), Serotonin and norepinephrine reuptake inhibitors (SNRIs), A serotonin-norepinephrine-dopamine reuptake inhibitors (SNDRIs), Tricyclic antidepressants (TCAs), stimulants, cannabis, and other medications, supplements or therapeutics that a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility as Assessed by Number of Participants who Complete the Trial (Overall Retention)

Timeframe: from baseline to 3 weeks after first administration session

Feasibility as Assessed by Number of Therapy Sessions Attended

Timeframe: from baseline to 3 weeks after first administration session

Feasibility as Assessed by Number of Assessments Completed

Timeframe: from baseline to 3 weeks after first administration session

Acceptability of Two Dosing Sessions as Assessed by Number of Participants who Choose to Participate in a Second Administration Session

Timeframe: 11 weeks after first administration session

Acceptability as Assessed by Number of Therapy Sessions Attended

Timeframe: from baseline to 11 weeks after first administration session

Acceptability as Assessed by Number of Assessments Completed

Timeframe: from baseline to 11 weeks after first administration session

Trial details

NCT IDNCT06706232

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Thomas Meyer, PhD

713-486-2643 thomas.d.meyer@uth.tmc.edu

View on ClinicalTrials.gov More Bipolar II Disorder trials

Who can participate

Age range

25 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility as Assessed by Number of Participants who Complete the Trial (Overall Retention)

Timeframe: from baseline to 3 weeks after first administration session

Feasibility as Assessed by Number of Therapy Sessions Attended

Timeframe: from baseline to 3 weeks after first administration session

Feasibility as Assessed by Number of Assessments Completed

Timeframe: from baseline to 3 weeks after first administration session

Acceptability of Two Dosing Sessions as Assessed by Number of Participants who Choose to Participate in a Second Administration Session

Timeframe: 11 weeks after first administration session

Acceptability as Assessed by Number of Therapy Sessions Attended

Timeframe: from baseline to 11 weeks after first administration session

Acceptability as Assessed by Number of Assessments Completed

Timeframe: from baseline to 11 weeks after first administration session