Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder
Purpose
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).
Conditions
- Borderline Personality Disorder
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 - Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS) score of > 20 - 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open-label treatment study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental: Psilocybin |
Single 25 mg capsule oral dose of psilocybin |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Chicago
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 with MDD and BPD will receive a single 25 mg oral dose of psilocybin. The hypothesis to be tested is that psilocybin will result significant reduction in symptoms of both MDD and BPD after 1 week and sustained for 4 weeks compared to baseline (improvement in symptoms will be indicated by lower scores on established outcome measures of MDD and BPD symptoms that have been used in prior studies).
