Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality
Recruiting · Houston, Texas
Always free
Study care at no cost to you
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Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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 this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •You must be at least 25 years old (and younger than 70) at the screening visit.
- •You must have Bipolar II depression diagnosed using DSM-5 records and a structured interview (DIAMOND).
- •You must have enough risk based on the INQ scores for passive suicidal thoughts (Perceived Burden and Thwarted Belongingness).
- •You must have depression scores in a mild-to-moderate range based on MADRS (score 7–34).
- •You must agree to taper mood-stabilizer and other specified medicines and be off medication for at least 2 weeks before dosing, and stop any allowed meds at least 24 hours before psilocybin as advised.
🚫 You may not be able to join if…
- •You cannot join if you do not read/speak English.
- •You cannot join if you have active suicidal thoughts with intent or a plan (C-SSRS score of 4 or 5).
- •You cannot join if you attempted suicide in the last 6 months.
- •You cannot join if you have Bipolar I disorder, psychotic symptoms/disorders, or certain other serious psychiatric conditions that would make participation unsafe.
- •You cannot join if you are currently in a hypomanic or mixed-symptom episode, or if you have certain personality disorder types (based on DSM-5 interview and/or clinical judgment).
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 25–70
- ✓Have Anxiety
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06706232 · Locations: Texas