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

Sheppard Pratt Health System

Status and phase: Completed; Phase 2

Conditions: Suicidal Ideation; Treatment Resistant Depression

Treatments: Drug: Psilocybin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05220410

49348

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Psilocybin

Experimental group

Description:

25mg of Psilocybin

Treatment:

Drug: Psilocybin