Clinical TrialMajor Depressive Disorder (MDD)PsilocybinCompleted

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

Open-label, single-group Phase II study (n=10) assessing a single 25 mg oral dose of psilocybin for adults with MDD and co-occurring BPD to evaluate safety and efficacy.

Target Enrollment
10 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Ten adults with current major depressive disorder and borderline personality disorder will receive a single 25 mg oral dose of psilocybin in an open-label treatment study to evaluate safety and symptom change.

Primary hypothesis is that psilocybin will produce a significant reduction in MDD and BPD symptom scores at 1 week sustained to 4 weeks compared to baseline; outcomes include standard rating scales such as MADRS and BPD-SAS.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Single 25 mg oral dose of psilocybin (open-label single-group).

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg oral capsule

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

Locations

University of Chicago — Chicago, Illinois, United States

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