Recruiting
Phase 2

Psilocybin

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06706232

Conditions

Bipolar II Disorder

Depression, Bipolar

Suicidality

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Not accepted

Interventions

Psilocybin

Therapeutic Support

Study Details

Brief 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.

Conditions

Bipolar II Disorder

Depression, Bipolar

Suicidality

Study ID

NCT06706232

Start date

Jul 7, 2025

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psilocybin with therapeutic support

Up to two sequential administrations of 25 mg psilocybin with additional therapeutic support.

Interventions

Psilocybin

Two sequential administrations of 25 mg psilocybin, 4 weeks apart.

Therapeutic Support

Five preparatory in-person psychotherapy sessions will be offered before the first administration session during weeks 1, 2, 3, 4, and 5. The optional second administration session will be preceded by a shorter 60 min preparatory session the day before.

Each administration session will be followed by 3 integration sessions and will adopt a Mindfulness-based CBT approach (M-CBT), in which a therapist will help the participant to process their experience and how to translate this into actual changes in everyday life.

If participants prefer more psychological support after the second administration session, they will be offered additional, optional therapy sessions for the duration of the trial regardless if they opted for a second administration session or not.

Primary outcome measure

  • Feasibility as Assessed by Number of Participants who Complete the Trial (Overall Retention) [ Time Frame: from baseline to 3 weeks after first administration session ]
  • Feasibility as Assessed by Number of Therapy Sessions Attended [ Time Frame: from baseline to 3 weeks after first administration session ]
  • Feasibility as Assessed by Number of Assessments Completed [ Time Frame: 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 [ Time Frame: 11 weeks after first administration session ]
  • Acceptability as Assessed by Number of Therapy Sessions Attended [ Time Frame: from baseline to 11 weeks after first administration session ]
  • Acceptability as Assessed by Number of Assessments Completed [ Time Frame: from baseline to 11 weeks after first administration session ]
  • Score on the Thwarted Belongingness (TB) Items of the Interpersonal Needs Questionnaire (INQ-15) [ Time Frame: baseline, 3 weeks after first administration session ]
  • Score on the Perceived Burdensomeness (PB) Items of the Interpersonal Needs Questionnaire (INQ-15) [ Time Frame: baseline, 3 weeks after first administration session ]
  • Score on the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, 3 weeks after first administration session ]

Central Contacts and Locations

Central contacts

Thomas Meyer, PhD

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

Griffin McClain

7134862643Griffin.McClain@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77006

Contacts

Thomas Meyer, PhD

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

Griffin McClain

713-486-2643Griffin.McClain@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 12, 2026

Last verified

Jul, 2026

Keywords

  • Bipolar II Depression
  • Psilocybin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-08-12.