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

Psilocybin

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).

Intervention / Treatment

Open-label treatment study
  • Psilocybin (DRUG)
    Psilocybin 25mg capsule

Condition or Disease

  • Borderline Personality Disorder
  • Major Depressive Disorder

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Not yet recruiting
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 10 (ESTIMATED)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Oct 01, 2023 ESTIMATED
    Primary Completion: Jul 01, 2024 ESTIMATED
    Completion Date: Aug 01, 2024 ESTIMATED
    Study First Posted: Jun 01, 2022 ACTUAL
    Last Updated: Sep 20, 2023

    Sponsors / Collaborators

    Lead Sponsor: University of Chicago
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Chicago, Illinois, USA

    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).

    Participant Groups

    • Single 25 mg capsule oral dose of psilocybin

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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."

    • 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.

    Secondary Outcomes

    • 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"

    • 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"

    More Details

    NCT Number: NCT05399498
    Other IDs: IRB22-0272
    Study URL: https://clinicaltrials.gov/study/NCT05399498
    Last updated: Sep 29, 2023