Comparing Esketamine, Crisis Response Planning, and Enhanced Usual Care to Prevent Suicide in Adolescents and Adults in Brazil

What this Trial Is About

Suicide is a leading cause of early death worldwide, with rising rates especially in low- and middle-income countries like Brazil where access to specialized care is limited. This trial evaluates whether adding a single esketamine infusion or a Crisis Response Planning session to enhanced treatment as usual eTAU can better prevent future suicide-related events in adolescents and adults aged 14 and older who recently attempted suicide or have severe suicidal thoughts. The study also examines which approach provides faster or longer-lasting improvements in mental health and quality of life, and assesses feasibility and cost-effectiveness in a public health setting. Participants are randomly assigned to one of three groups a single intravenous esketamine infusion with continuous monitoring plus eTAU a 20- to 45-minute Crisis Response Planning session with a trained clinician plus eTAU or eTAU alone, which includes standard emergency care, lethal means safety counseling, connection to mental health services, and a psychiatric follow-up within 7 days. Esketamine is administered in a clinical setting with safety monitoring for up to 24 hours, while Crisis Response Planning involves creating a personalized written and digital safety plan. Participants experiencing a new suicide-related event during the study may receive an open-label combined rescue treatment. Throughout the one-year study, participants complete questionnaires at 11 time points assessing suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life. They provide a blood sample at baseline for exploratory biomarker analysis and use a smartphone app to report mood and thoughts four times daily for four weeks. Safety is monitored continuously, and assessments include a wide range of validated mental health scales. The study reflects real-world emergency care in Brazils public health system and aims to inform scalable suicide prevention strategies.

Esketamine Versus Crisis Response Planning Versus Optimized Treatment as Usual for Suicide Prevention: A Pragmatic Controlled Trial in Two Brazilian Cities