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

Launched by UNIVERSITY OF SAO PAULO · Aug 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying ways to prevent suicide in people at high risk who come to emergency departments in two Brazilian cities. It compares three approaches: a single dose of esketamine (a fast-acting medicine given through an IV), a Crisis Response Plan (a personalized safety plan created with a mental health professional), and the usual care with extra support like a guaranteed follow-up appointment. The goal is to see which method works best to reduce future suicide attempts, hospital visits, or self-harm over the course of one year.

People aged 14 and older who have recently attempted suicide, had severe thoughts about suicide, or harmed themselves without intending to die but needed emergency care may be eligible to join. Participants will be carefully monitored, including receiving medical checks during the esketamine treatment or working with a psychologist to develop their safety plan. Everyone will get enhanced usual care, including follow-up mental health support. The study also collects blood samples and gathers information about mood and behavior over time to better understand how these treatments work and who benefits most. This trial aims to provide valuable information to improve suicide prevention in real-world healthcare settings.

Gender

ALL

Eligibility criteria

• * Inclusion Criteria:
• • Age ≥ 14 years
• • Recent suicide attempt within 30 days (actual, interrupted, or aborted)
• • Severe suicidal ideation (positive response to questions 4 or 5 on Columbia-Suicide Severity Rating Scale screening version)
• • Non-suicidal self-harm requiring medical attention in emergency department setting
• • Resident of Jaguariúna, Indaiatuba, or surrounding areas
• • Able to provide informed consent (or assent with guardian consent for minors)
• • Not requiring long-term psychiatric hospitalization after emergency evaluation
• * Exclusion Criteria:
• • Medical conditions contraindicated for esketamine use (aneurysmal vascular disease, arteriovenous malformation, intracerebral hemorrhage, known hypersensitivity to esketamine)
• • Need for intensive care unit admission without possibility of later study participation
• • Severe substance use disorders interfering with protocol adherence
• • Psychotic disorders
• • Lack of stable housing or inability to be contacted for follow-up assessments
• • History of non-response to esketamine or previous enrollment in esketamine studies
• • Pregnancy or breastfeeding
• • Inability to provide informed consent due to cognitive impairment or explicit refusal to participate