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

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

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