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Completed

NCT Number: NCT05399498

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

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).

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Key information

Conditions

Borderline Personality Disorder Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders Personality Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psilocybin

Drug

Psilocybin 25mg capsule

Primary outcomes

  1. 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."

  2. Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS)

    Time frame: Baseline to Week 5

    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

  1. 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"

  2. 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"

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Usona Institute

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2022
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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