COMPLETED

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

Conditions

Borderline Personality Disorder Major Depressive Disorder BPD MDD Psilocybin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-11-01

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05399498

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Jon E Grant, MD, JD, MPH

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University of Chicago

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Jon E Grant, MD, JD, MPH, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-11-01

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

BPD
MDD
Psilocybin

Additional Relevant MeSH Terms

Borderline Personality Disorder
Major Depressive Disorder