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

Primary Purpose

Borderline Personality Disorder, Major Depressive Disorder

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring BPD, MDD, Psilocybin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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
  • 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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Psilocybin

Arm Description

Single 25 mg capsule oral dose of psilocybin

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS)
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."
Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS)
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 Outcome Measures

Clinical Global Impression - Severity scale (CGI-S)
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)
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"

Full Information

First Posted
May 26, 2022
Last Updated
September 20, 2023
Sponsor
University of Chicago
Collaborators
Usona Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05399498
Brief Title
Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder
Official Title
An Open Label Study of Single-Dose Psilocybin for Major Depressive Disorder With Co-occurring Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Usona Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Major Depressive Disorder
Keywords
BPD, MDD, Psilocybin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label treatment study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Psilocybin
Arm Type
Experimental
Arm Description
Single 25 mg capsule oral dose of psilocybin
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
Psilocybin 25mg capsule
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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."
Time Frame
Baseline to Week 5
Title
Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS)
Description
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.
Time Frame
Baseline to Week 5
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Severity scale (CGI-S)
Description
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"
Time Frame
Baseline to Week 5
Title
Clinical Global Impression - Improvement scale (CGI-I)
Description
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"
Time Frame
Week 2 to Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madison Collins, BA
Phone
773-834-3778
Email
mcollins4@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD, MPH
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eve K Chesivoir, BA
Phone
773-702-9066
Email
chesivoir@uchicago.edu
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD, MPH
First Name & Middle Initial & Last Name & Degree
Dustin A Ehsan, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Gunderson J: Borderline Personality Disorder, 2nd ed. Washington, DC, American Psychiatric Press, 2000
Results Reference
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Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder

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