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CompletedPhase 2

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

NCT05399498 · University of Chicago

Closed to entry
Status
Not accepting participants
Phase 2
Phase
9
Target enrolment
1
Study sites
1 US states

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    Measured over Baseline to Week 5

  • Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS)

    Measured over Baseline to Week 5

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
University of ChicagoChicagoIllinoisUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05399498 on ClinicalTrials.gov →

Last updated in the registry 2025-12-23. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 12 trials from University of Chicago →