Status:
COMPLETED
Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Usona Institute
Conditions:
Borderline Personality Disorder
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD).
Detailed Description
The primary objective of the proposed study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD). Ten subjects ...
Eligibility Criteria
Inclusion
- Age 18-65
- Diagnosed with current major depressive disorder
- Montgomery-Asberg Depression Rating Scale (MADRS) score of \> 20
- Diagnosed with borderline personality disorder
- Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS) score of \> 20
- Ability to understand and sign the consent form
Exclusion
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Illegal substance use based on urine toxicology screening (except cannabis use)
- Current or past history of bipolar I disorder, schizophrenia, or schizoaffective disorder
- Active substance use disorder
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05399498
Start Date
November 1 2023
End Date
December 1 2025
Last Update
December 23 2025
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637