Evaluation of the Efficacy and Safety of Subcutaneous Ketamine in the Treatment of Depressive Episode With Suicidal Ideation and/​or Behavior in Adolescents

This randomised, double-blind, placebo-controlled Phase III trial (n=60) will investigate the efficacy and safety of subcutaneous ketamine (35-70mg/70kg, twice weekly for four weeks) as an add-on treatment for adolescents experiencing a major depressive episode with suicidal ideation and/or behaviour.

Led by Dr Sheila Caetano at the Federal University of São Paulo, the study targets adolescents aged 12 to 19 who are already undergoing standard treatment for depression but continue to exhibit significant depressive symptoms and suicide risk.

Participants will be randomly assigned to receive either ketamine or an active placebo (1 mg midazolam) administered subcutaneously. All treatments will be given under medical supervision, and dose adjustments will be permitted based on the patient’s response and tolerability. The trial will evaluate rapid antidepressant effects within 24 hours of the first dose, using the Montgomery–Åsberg Depression Rating Scale (MADRS) and Columbia Suicide Severity Rating Scale (C-SSRS) to measure symptom remission and reductions in suicidal thoughts and behaviours. This study aims to provide evidence for ketamine as a fast-acting intervention in a highly vulnerable youth population.

Topic Depression Suicidality Safety
Compound Ketamine Placebo
Country Brazil
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Sponsors & Collaborators

University of São Paulo
The University of São Paulo has been conducting research with psychedelics for many years, with a focus on ayahuasca given its traditional use in Brazil.

Data attribution

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