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

Launched by FEDERAL UNIVERSITY OF SÃO PAULO · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called subcutaneous ketamine on adolescents who are experiencing severe depression and have thoughts or behaviors related to suicide. The goal is to see if adding ketamine to their usual treatment can improve their mood and overall mental health compared to those receiving a placebo (a harmless substitute that looks like the real medication but has no effects). The trial is aimed at young people aged 12 to 19 years old who have been diagnosed with a major depressive episode and have been struggling with suicidal thoughts or actions.

To participate in this study, eligible participants must be receiving regular treatment for their depression and have scores indicating severe depression on specific rating scales. However, some individuals may not qualify if they have certain mental health conditions, a history of substance abuse, or significant medical issues. Participants can expect to receive treatment in a safe environment, and their progress will be closely monitored throughout the trial. It's important to note that the trial is not yet recruiting participants, so interested individuals will need to wait for further announcements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 12 and 19 years.
• • Diagnosis of Major Depressive Episode, unipolar, made through the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS-PL) administered by experienced evaluators, using DSM-5 criteria.
• • Under usual treatment for Major Depressive Episode, including clinically indicated psychopharmacological treatment and/or psychosocial treatment at one of the two collaborating clinics (DICA and Conversas de Vida / Unifesp).
• • Score ≥ 25 on the MADRS (Montgomery-Åsberg Depression Rating Scale).
• • Score ≥ 28 on the CDRS (Children Depression Rating Scale).
• • Score ≥ 2 on the Columbia Suicide Severity Rating Scale (C-SSRS).
• • History of suicide attempt or significant suicidal ideation or planning with a plan or intention requiring emergency evaluation in the last 30 days.
• Exclusion Criteria:
• • Presence of the following psychiatric comorbidities: Autism Spectrum Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, or psychiatric disorder secondary to physical illness, and history of ketamine or other substance abuse or dependence in the last 6 months.
• • Presence of Intellectual Disability (assessed by IQ testing).
• • Presence of the following clinical comorbidities: history of myocardial infarction, congenital heart disease, decompensated cardiac arrhythmia, decompensated hypertension, porphyria, stroke, brain trauma with loss of consciousness, intracranial hypertension, hydrocephalus, central nervous system tumors, or central nervous system abnormalities.
• • Previous treatment for depression with esketamine.
• • Allergy to esketamine.
• • If female: pregnancy or breastfeeding.