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Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Sponsor: University of Sao Paulo
Summary
This randomized, double-blind, active placebo-controlled superiority trial will evaluate whether intravenous esketamine reduces time to psychiatric hospital discharge in adults hospitalized because of acute suicide risk. A total of 106 participants will be randomized in a 1:1 ratio to receive intravenous esketamine or midazolam as an active placebo. Participants assigned to esketamine will receive eight 40-minute intravenous infusions at a dose of 0.5 mg/kg administered twice weekly. The primary outcome is time from the first study infusion to psychiatric hospital discharge. Secondary outcomes include suicidal ideation and behavior, depressive symptoms, psychological pain, hopelessness, global clinical improvement, safety, tolerability, dissociative symptoms, and healthcare costs. Exploratory analyses will investigate peripheral inflammatory markers, BDNF, and polygenic risk scores as potential predictors or mediators of treatment response. Clinical follow-up will continue through Week 12.
Official title: Intravenous Ketamine for the Management of Acute Suicidal Crisis: Effect on Psychiatric Hospital Length of Stay - A Randomized, Double-Blind, Active Placebo-Controlled Superiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2027-04-30
Completion Date
2029-03-30
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
Esketamine
ntravenous esketamine 0.5 mg/kg diluted in 100 mL of 0.9% saline, administered over 40 minutes twice weekly for a total of eight infusions.
Midazolam (Intravenous)
Intravenous midazolam 0.045 mg/kg diluted in 0.9% saline and administered as an active placebo.
Locations (1)
Institute of Psychiatry, Hospital das Clínicas, University of São Paulo Medical School
São Paulo, São Paulo, Brazil