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Psychedelic Therapy
Psilocybin for Bipolar Disorder
Phase 2
Waitlist Available
Led By Thomas Meyer, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be at 25 years of age or older at screening (but below age of 70)
Must meet criteria for depression according to the MADRS cutoff scores
Must not have
Have a first or second degree relative with Bipolar I disorder or a psychotic disorder
Participants who do not read/speak English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 weeks after first administration session
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if giving patients with Bipolar Disorder (type II) depression two doses of 25 mg psilocybin, along with therapy, can help reduce suicidal thoughts and behaviors.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of psilocybin include nausea, headache, dizziness, increased heart rate or blood pressure, emotional distress, and changes in perception during the dosing session.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 25 and 70 years old.
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I have been diagnosed with depression based on MADRS scores.
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I can complete all required health assessments by myself.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
A close family member has Bipolar I or a psychotic disorder.
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I cannot read or speak English.
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I am currently experiencing a hypomanic or mixed episode.
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I have a history of serious mental health issues, including bipolar I or psychosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 weeks after first administration session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 weeks after first administration session
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility as Assessed by Number of Participants who Complete the Trial (Overall Retention)
Score on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Score on the Perceived Burdensomeness (PB) Items of the Interpersonal Needs Questionnaire (INQ-15)
+1 moreSecondary study objectives
Psychiatric Symptoms as Assessed by Score on the Brief Psychiatric Rating Scale (positive symptom subscale) (BPRS+)
Score on the Altman Self-Rating Mania Scale (ASRM)
Score on the Montgomery-Åsberg Depression Rating Scale (MADRS)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Psilocybin with therapeutic supportExperimental Treatment2 Interventions
Up to two sequential administrations of 25 mg psilocybin with additional therapeutic support.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,847 Total Patients Enrolled
11 Trials studying Bipolar Disorder
1,587 Patients Enrolled for Bipolar Disorder
Anne and Don Fizer FoundationUNKNOWN
Thomas Meyer, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston