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Can a psychedelic compound ease suicidal thoughts in bipolar depression?
NCT ID NCT06706232
First seen Jul 30, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This phase 2 trial is investigating whether two doses of psilocybin (25 mg each, given 4 weeks apart) combined with psychotherapy are safe and acceptable for people with bipolar II disorder who are experiencing depression and suicidal thoughts. The study enrolls 10 adults aged 25–70 and measures feasibility, retention, and changes in suicidal ideation and depression scores. It aims to see if this approach could offer a new way to help those with treatment-resistant symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- psilocybin (25 mg) given twice, 4 weeks apart, plus therapeutic support including preparatory and integration sessions
- What this could lead to
- If safe and acceptable, this approach could point toward a new treatment option for bipolar II depression with suicidal thoughts.
- What could go wrong
- This is a very small early-phase trial with only 10 participants, so results may not apply broadly. Psilocybin can cause intense psychological effects and is not yet proven safe in this population.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 affect serotonergic function) for the duration of the study before and during administration days (starting 5 weeks before administration), and be off medication for at least 2 weeks prior to administration * Willingness to stop allowed medication at least 24 h prior to administration of psilocybin as advised by study physician (e.g., benzodiazepines) * Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits Exclusion Criteria: * Participants who do not read/speak English * Active suicidal ideation with at least some intent and/or plan (i.e., a current score of 4 or 5 on the C-SSRS) * History of medically significant suicide attempt in the last 6 months * Current or past history of Bipolar I disorder, psychotic symptoms or psychotic disorder, (including but not limited to schizophrenia, delusional disorder, schizoaffective disorder) clinically relevant personality disorder (such as borderline, antisocial, narcissistic or paranoid personality disorder), or any serious psychiatric comorbidity considered negatively impacting participation or safety (e.g., PTSD or severe substance use or alcohol disorder) assessed by medical history and/or a structured clinical interview * Have a first or second degree relative with Bipolar I disorder or a psychotic disorder * Currently experiencing a hypomanic or mixed-symptom episode * Have a psychiatric or other condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin * Any indication of a Personality Disorder (PD) such as but not limited to Borderline, Narcissistic, Antisocial, Paranoid, or Schizotypal PD based on Structured Clinical Interview for DSM-5 for PD and/or clinical judgment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas Health Science Center at Houston
RECRUITINGHouston, Texas, 77006, United States
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