NCT05399498

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

An Open Label Study of Single-Dose Psilocybin for Major Depressive Disorder With Co-occurring Borderline Personality Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Borderline Personality Disorder
• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin	Psilocybin 25mg capsule

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-06-01
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study