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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Suicide PreventionKetamineCrisis Response Plan
Interventions
DRUG

Intravenous Esketamine

Single-session intravenous esketamine infusion (0.5 mg/kg) administered over 40 minutes in a medical setting with continuous monitoring of vital signs, blood pressure, ECG, and oxygen saturation for 4 hours post-infusion. Administration supervised by trained medical staff with emergency protocols available. Participants will be discharged 24 hours post-infusion if no clinical complications arise, with ambulatory evaluations at 48 hours, 72 hours, and 7 days post-infusion.

OTHER

Crisis Response Planning intervention (structures safety planning)

Collaborative safety planning intervention delivered by trained clinical psychologists in 20-45 minute sessions. Participants create personalized, written crisis response plans identifying warning signs of emotional distress, internal coping strategies, social support contacts, professional resources, and means restriction methods. The intervention follows a structured format focusing on practical crisis management tools that participants can implement during suicidal crises.

All Listed Sponsors
lead

University of Sao Paulo

OTHER