Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinCompleted

The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation

This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation.

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

Detailed Description

Open-label, single-group Phase II study (n=20) assessing a single 25 mg oral dose of psilocybin with supportive psychological care in adults with treatment-resistant depression and chronic suicidal ideation.

Primary aims are safety and tolerability; assessments include adverse events, measures of suicidality and depressive symptoms, and standard clinical safety monitoring.

Key eligibility includes MDD with active suicidal ideation without immediate intent and failure to respond to at least two medications. Sponsor and site: Sheppard Pratt Health System, Baltimore, MD, USA.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin

experimental

Single-group open-label 25 mg psilocybin

Interventions

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

    Open-label, single 25 mg dose with supportive psychological care

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Between 18 and 65 years of age at Screening
  • Diagnosis of Major Depressive Disorder (MDD)
  • Significant level of suicidal thoughts with active ideation and without immediate intent
  • Failure to respond to 2 medications in the current episode

Exclusion Criteria

  • Exclusion Criteria:
  • Current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc.
  • Current alcohol or substance use disorder

Study Details

Locations

Sheppard Pratt Health System — Baltimore, Maryland, United States

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