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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06706232
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    Two sequential administrations of 25 mg psilocybin, 4 weeks apart.
  • Therapeutic Support — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 7, 2025
Status verified
Jul 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin with therapeutic support
    Up to two sequential administrations of 25 mg psilocybin with additional therapeutic support.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77006
Thomas Meyer, PhD
[email protected]
713-486-2643
Lauren Vale, MA
[email protected]
713-486-2643
Jair C. Soares, MD, PhD (SUB_INVESTIGATOR)
Joao De Quevedo, MD, PhD (SUB_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
The University of Texas Health Science Center at Houston· Houston, TX

Related Studies