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

Purpose

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

Conditions

  • Treatment Resistant Depression
  • Suicidal Ideation

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Psilocybin
25mg of Psilocybin
  • Drug: Psilocybin
    Open-Label

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Sheppard Pratt Health System

Study Contact

Audrey Shoultz
4109385263
audrey.shoultz@sheppardpratt.org