A Phase 2 interventional study of Psilocybin and Therapeutic Support in Bipolar II Disorder, Depression, Bipolar and Suicidality, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Treatment
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.
This study aims to determine whether psilocybin paired with psychotherapy is a safe, feasible, and acceptable treatment for Bipolar II (BD II) depression, specifically, individuals experiencing suicidal ideation (without having an active plan or intention to act). The design is a non-randomized clinical trial, where patients will receive up to 2 doses of 25mg psilocybin in the context of psychological support informed by mindfulness-based CBT and typical elements of psychedelic treatments (e.g., preparation, intention setting, integration). The investigators will measure suicidality, depression, and acute experiences using validated questionnaires at multiple time points in the study. If this study shows psilocybin to be a feasible, acceptable, and safe treatment option, this would have huge implications for improving outcomes because highly effective treatment for suicidality in patients with Bipolar Disorder is still lacking.
Exclusion Criteria:
Up to two sequential administrations of 25 mg psilocybin with additional therapeutic support.
Drug: Psilocybin · Behavioral: Therapeutic Support
Two sequential administrations of 25 mg psilocybin, 4 weeks apart.
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.
Feasibility as Assessed by Number of Participants who Complete the Trial (Overall Retention)
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.
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)
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.
Time frame: baseline, 3 weeks after first administration session
Score on the Perceived Burdensomeness (PB) Items of the Interpersonal Needs Questionnaire (INQ-15)
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.
Time frame: baseline, 3 weeks after first administration session
Score on the Columbia-Suicide Severity Rating Scale (C-SSRS)
The total score on the C-SSRS ranges from 0-5, with 5 indicating the highest level of suicidal ideation.
Time frame: baseline, 3 weeks after first administration session
Score on the Montgomery-Åsberg Depression Rating Scale (MADRS)
The total score on the MADRS ranges from 0 to 60, with a higher score indicating a greater depression.
Time frame: baseline, 3 weeks after first administration session
Score on the Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Total score on the QIDS-SR16 ranges from 0 to 27, where higher scores indicate a higher occurence of depressive symptoms.
Time frame: baseline, 3 weeks after first administration session
Score on the Young Mania Rating Scale (YMRS)
The total score on the YMRS ranges from 0 to 60, with higher scores indicating greater severity of mania.
Time frame: baseline, 3 weeks after first administration session
Psychiatric Symptoms as Assessed by Score on the Brief Psychiatric Rating Scale (positive symptom subscale) (BPRS+)
The total score on the BPRS+ ranges from 4 to 28, with higher scores indicating a higher severity of psychopathology.
Time frame: baseline, 3 weeks after first administration session
Score on the Altman Self-Rating Mania Scale (ASRM)
The total score on the ASRM ranges from 5-25, with higher scores indicating more severity of mania.
Time frame: baseline, 3 weeks after first administration session
Plan to share: No
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The University of Texas Health Science Center, Houston