Psilocybin for Bipolar Disorder

Overseen By Jair C. Soares, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Antidepressants, Antipsychotics, Lithium, others

Disqualifiers: Bipolar I, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Thomas Meyer, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals with Bipolar Disorder II who are experiencing depression and may have suicidal thoughts. Participants must be stable on their current medications and in good physical health to handle the psilocybin treatment.

Inclusion Criteria

Must have completed written informed consent

I have been diagnosed with depression based on MADRS scores.

Ability to comply with all study visits

Exclusion Criteria

Active suicidal ideation with at least some intent and/or plan

A close family member has Bipolar I or a psychotic disorder.

History of medically significant suicide attempt in the last 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to two sequential doses of 25 mg psilocybin with therapeutic support

3 weeks

Multiple visits for administration and therapeutic support

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

Follow-up visits to assess outcomes

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study is testing if taking up to two doses of 25 mg psilocybin, along with therapeutic support, can reduce suicidality in patients with Bipolar Disorder II depression.

How Is the Trial Designed?

Group I: Psilocybin with therapeutic support Experimental Treatment 2 Interventions

Up to two sequential administrations of 25 mg psilocybin with additional therapeutic support.

Psilocybin is already approved in United States, European Union for the following indications:

Approved in United States as Psilocybin for:

• Treatment-resistant depression (TRD) under Breakthrough Therapy designation

Approved in European Union as Psilocybin for:

• Treatment-resistant depression (TRD) under PRIME designation

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Anne and Don Fizer Foundation

Collaborator

Trials

1

Recruited

10+