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