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

PHASE2RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

July 7, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2027

Conditions
Bipolar II DisorderDepression, BipolarSuicidality
Interventions
DRUG

Psilocybin

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

BEHAVIORAL

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."

Trial Locations (1)

77006

RECRUITING

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

Anne and Don Fizer Foundation

UNKNOWN

lead

The University of Texas Health Science Center, Houston

OTHER

NCT06706232 - Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality | Biotech Hunter | Biotech Hunter