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

Phase 2

Recruiting

• Conditions: Borderline Personality Disorder; Major Depressive Disorder
• Interventions: Drug: Psilocybin

• Registration Number: NCT05399498
• Lead Sponsor: University of Chicago

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 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).

Study Timeline

• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Study Start: 2023-11-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Psilocybin	Psilocybin	Single 25 mg capsule oral dose of psilocybin

Primary Outcome Measures

Name	Time	Method
Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS)	Baseline to Week 5	One of the co-primary outcome measures will be the change from baseline using the Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS). The BPD-SAS covers a two-week time frame and each of the nine criteria, each representing symptoms of BPD, for BPD is rated on a five-point anchored rating scale of 0-4, with 0 representing no symptoms and 4 representing extreme symptoms.
Montgomery-Asberg Depression Rating Scale (MADRS)	Baseline to Week 5	One of the co-primary outcome measures will be the change from baseline using the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS is a 10-item, clinician-administered scale that assesses depression symptoms during the last seven days. Each item is rated on a scale from 0 to 6, with 0 being "normal/not present" and 6 being "extreme."

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Improvement scale (CGI-I)	Week 2 to Week 5	A clinician administered, single item scale measuring overall improvement of global severity of psychiatric illness. The scale itself assesses overall disorder improvement on a scale from 1 to 7 with 1 being "Very much improved" and 7 being "Very much worse"
Clinical Global Impression - Severity scale (CGI-S)	Baseline to Week 5	A clinician administered, single item scale measuring global severity of psychiatric illness. The scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases"

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States