Anxiety & Depression Association of America

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

Arm	Description	Assigned 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.