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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05399498
Recruitment Status : Not yet recruiting
First Posted : June 1, 2022
Last Update Posted : August 5, 2022
Sponsor:
Collaborator:
Usona Institute
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE May 26, 2022
First Posted Date  ICMJE June 1, 2022
Last Update Posted Date August 5, 2022
Estimated Study Start Date  ICMJE December 2022
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2022)
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 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."
  • Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) [ Time Frame: Baseline to Week 5 ]
    One of the co-primary outcome measures will be the change from baseline using theZanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD). The ZAN-BPD covers a one-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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2022)
  • Clinical Global Impression - Severity scale (CGI-S) [ Time Frame: 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"
  • Clinical Global Impression - Improvement scale (CGI-I) [ Time Frame: 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"
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder
Official Title  ICMJE An Open Label Study of Single-Dose Psilocybin for Major Depressive Disorder With Co-occurring Borderline Personality Disorder
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open-label treatment study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Borderline Personality Disorder
  • Major Depressive Disorder
Intervention  ICMJE Drug: Psilocybin
Psilocybin 25mg capsule
Study Arms  ICMJE Experimental: Experimental: Psilocybin
Single 25 mg capsule oral dose of psilocybin
Intervention: Drug: Psilocybin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 26, 2022)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) score of > 9
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eve K Chesivoir, BA 7737029066 chesivoir@uchicago.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05399498
Other Study ID Numbers  ICMJE IRB22-0272
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Chicago
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Usona Institute
Investigators  ICMJE
Principal Investigator: Jon E Grant, MD, JD, MPH University of Chicago
PRS Account University of Chicago
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP