Back to search results

Psilocybin for Bipolar II Depression and Suicidality

This study is looking at whether two doses of psilocybin (a psychedelic compound) along with therapy sessions are safe and acceptable for people aged 25 to 70 who have Bipolar II Disorder and depression, especially if they are experiencing suicidal thoughts. You would receive two 25 mg doses of psilocybin, four weeks apart, with several therapy sessions before each dose. The researchers want to see how many people complete the study, attend therapy, and finish all assessments. This will help them understand if psilocybin could be a helpful treatment option, as effective treatments for suicidality in Bipolar Disorder are still needed. The study plans to enroll 10 participants, but its current recruitment status is unclear.

Study design
This is an interventional, non-randomized clinical trial planning to enroll 10 participants. It is not specified if it is open-label or blinded.
What's involved
You would have five in-person psychotherapy sessions before the first psilocybin dose, and a shorter session before the optional second dose. You would also complete questionnaires at multiple times.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured from the start of the study until 3 weeks after the first psilocybin dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06706232

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

Recruiting
PHASE2Ages 25–70InterventionalTreatment
The University of Texas Health Science Center, Houston
~10 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:PsilocybinTherapeutic Support

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility as Assessed by Number of Participants who Complete the Trial (Overall Retention)
Measured over from baseline to 3 weeks after first administration session
+8 more outcomes measured

Conditions

Bipolar II Disorder
Depression, Bipolar
Suicidality

Explore related trials

Bipolar II DisorderDepressionSuicidal Ideation

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Thomas Meyer, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Thomas Meyer, PhD
[email protected]
713-486-2643
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Feasibility as Assessed by Number of Participants who Complete the Trial (Overall Retention)from baseline to 3 weeks after first administration session

    This is assessed by number of participants who complete the trial, that is, the number of participants who complete the first dose and follow-up visits up to 3 weeks after the first dose.

  • Feasibility as Assessed by Number of Therapy Sessions Attendedfrom baseline to 3 weeks after first administration session
  • Feasibility as Assessed by Number of Assessments Completedfrom 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 Session11 weeks after first administration session
  • Acceptability as Assessed by Number of Therapy Sessions Attendedfrom baseline to 11 weeks after first administration session
  • Acceptability as Assessed by Number of Assessments Completedfrom baseline to 11 weeks after first administration session
  • Score on the Thwarted Belongingness (TB) Items of the Interpersonal Needs Questionnaire (INQ-15)baseline, 3 weeks after first administration session

    The Thwarted Belongingness (TB) section of the INQ-15 has a total score range from 9 to 63, with a higher score indicating greater TB.

  • Score on the Perceived Burdensomeness (PB) Items of the Interpersonal Needs Questionnaire (INQ-15)baseline, 3 weeks after first administration session

    The Perceived Burdensomeness (PB) section of the INQ-15 has a total score range from 6 to 42, with a higher score indicating greater PB.

  • Score on the Columbia-Suicide Severity Rating Scale (C-SSRS)baseline, 3 weeks after first administration session

    The total score on the C-SSRS ranges from 0-5, with 5 indicating the highest level of suicidal ideation.