Loading
Therapeutic Support / Suicidality / Depression, Bipolar · Phase 2 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 feasibility and safety study registration for psilocybin-assisted therapy in bipolar II depression with suicidality, currently recruiting. No results are posted in this registry record; the study is designed to assess acceptability, retention, and safety endpoints rather than efficacy, and recruitment remains open.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Bipolar II Disorder, Depression, Bipolar, Suicidality; age from 25 Years; to 70 Years. Intervention: Psilocybin with therapeutic support. n = 10. 1 site: United States.
This is a Phase 2 feasibility and safety study registration for psilocybin-assisted therapy in bipolar II depression with suicidality, currently recruiting. No results are posted in this registry record; the study is designed to assess acceptability, retention, and safety endpoints rather than efficacy, and recruitment remains open.
Follow-up duration (11 weeks) is short; long-term safety and durability unknown.
Clinicians should note this is early-phase, hypothesis-generating work in a vulnerable population. No efficacy or safety data are yet available; results will inform whether larger trials in psilocybin-assisted therapy for bipolar suicidality are justified.
This is an active Phase 2 feasibility and safety study with no results posted; it measures acceptability and tolerability in a small planned cohort (n=10) with suicidality as a secondary focus, not a completed trial with efficacy data.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should note this is early-phase, hypothesis-generating work in a vulnerable population. No efficacy or safety data are yet available; results will inform whether larger trials in psilocybin-assisted therapy for bipolar suicidality are justified.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06706232). This is a study registration, not published results. Lead sponsor: The University of Texas Health Science Center, Houston. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 10 participants (ESTIMATED). Conditions: Bipolar II Disorder, Depression, Bipolar, Suicidality. Interventions: DRUG: Psilocybin; BEHAVIORAL: Therapeutic Support. Primary outcome measures: Feasibility as Assessed by Number of Participants who Complete the Trial (Overall Retention) , from baseline to 3 weeks after first administration session; Feasibility as Assessed by Number of Therapy Sessions Attended , from baseline to 3 weeks after first administration session; Feasibility as Assessed by Number of Assessments Completed , 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 , 11 weeks after first administration session; Acceptability as Assessed by Number of Therapy Sessions Attended , from baseline to 11 weeks after first administration session; Acceptability as Assessed by Number of Assessments Completed , from 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; Score on the Perceived Burdensomeness (PB) Items of the Interpersonal Needs Questionnaire (INQ-15) , baseline, 3 weeks after first administration session; Score on the Columbia-Suicide Severity Rating Scale (C-SSRS) , baseline, 3 weeks after first administration session. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.