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

Last updated: March 4, 2025
Sponsor: University of Chicago
Overall Status: Active - Recruiting

Phase

2

Condition

Depression

Affective Disorders

Depression (Adult And Geriatric)

Treatment

Psilocybin

Clinical Study ID

NCT05399498
IRB22-0272
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Unstable medical illness based on history or clinically significant abnormalities onbaseline physical examination

  • Current pregnancy or lactation, or inadequate contraception in women of childbearingpotential

  • Illegal substance use based on urine toxicology screening (except cannabis use)

  • Current or past history of bipolar I disorder, schizophrenia, or schizoaffectivedisorder

  • Active substance use disorder

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Psilocybin
Phase: 2
Study Start date:
November 01, 2023
Estimated Completion Date:
July 31, 2025

Study 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).

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

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