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

StatusRecruiting
PhasePhase 2
Started2025-07-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jan 2027 → Aug 2027
See other at-risk trials from The University of Texas Health Science Center, Houston

Amendment history

2026-08-11
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2026-07-28
Study Status, Oversight v6
Primary completion pushed: 2027-01 → 2027-08
Completion pushed: 2027-01 → 2027-08
2025-07-15
Study Status v5
Start date2025-03-26→2025-07-07
2025-07-02
Study Identification, Study Status v4
Study title+16 characters
Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality
2025-06-20
Study Status, Oversight, Eligibility v3
Start dateestimated 2025-03→confirmed 2025-03-26
Eligibility criteriarevised
[...] ity according to the INQ cutoff scores: A score of at least 1712 on the Perceived Burden (PB) subscale and at least a score of 2236 on the Thwarted Belongingness (TB) subscale indicating subs [...]
Show 2 earlier versions
2025-03-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-02-21
Study Status, Sponsor/Collaborators, Outcome Measures v1
Start date2025-01→2025-03
Secondary endpointsdetails revised at 1 of 5 entries
Primary endpoints7 to 9 entries
Acceptability as Assessed by Number of Assessments Completed Acceptability as Assessed by Number of Therapy Sessions Attended
2024-11-22
Original filing
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.
Trial Details
NCT Number NCT06706232
Lead Sponsor The University of Texas Health Science Center, Houston
Collaborators: Anne and Don Fizer Foundation
Conditions Bipolar II Disorder, Depression, Bipolar, Suicidality
Enrollment 10 participants
Start Date 2025-07-07
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-12