Overview

Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder

Status:
Not yet recruiting
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Chicago
Collaborator:
Usona Institute
Treatments:
Psilocybin
Criteria
Inclusion Criteria:

- Age 18-65

- Diagnosed with current major depressive disorder

- Montgomery-Asberg Depression Rating Scale (MADRS) score of > 20

- Diagnosed with borderline personality disorder

- Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) score of > 9

- Ability to understand and sign the consent form

Exclusion Criteria:

- 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