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

Sponsor

University of Chicago (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05399498

Collaborator

Usona Institute (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder Major Depressive Disorder	Drug: Psilocybin	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open-label treatment studyOpen-label treatment study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open Label Study of Single-Dose Psilocybin for Major Depressive Disorder With Co-occurring Borderline Personality Disorder

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Psilocybin Single 25 mg capsule oral dose of psilocybin	Drug: Psilocybin Psilocybin 25mg capsule

Arm

Intervention/Treatment

Experimental: Experimental: Psilocybin

Single 25 mg capsule oral dose of psilocybin

Drug: Psilocybin

Psilocybin 25mg capsule

Outcome Measures

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS) [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) [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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