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

The University of Chicago

Status and phase

Active, not recruiting

Phase 2

Conditions

Major Depressive Disorder

Borderline Personality Disorder

Treatments

Drug: Psilocybin

Study type

Interventional

Funder types

Other

Identifiers

NCT05399498

IRB22-0272

Details and patient eligibility

About

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).

Full 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).

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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
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