Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboNot yet recruiting

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.

Target Enrollment
60 participants
Study Type
Phase III interventional
Design
Randomized, double Blind

Detailed Description

Phase III randomised, double-blind, parallel-group trial comparing adjunctive subcutaneous ketamine (0.5–1.0 mg/kg, dose-adjusted) versus active placebo (midazolam 1 mg) given twice weekly for four weeks in adolescents with major depressive episode and active suicidal ideation/behaviour.

Primary efficacy outcomes include depression remission and response (MADRS); safety assessed via adverse event monitoring, clinical examinations and procedure monitoring (continuous and hourly checks for 3 hours post-dose).

Participants continue usual treatment during the trial; randomisation and blinding include participants and outcomes assessors.

Study Protocol

Preparation

sessions

Dosing

8 sessions
180 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine

experimental

Adjunctive subcutaneous ketamine, dose-adjusted 0.5–1.0 mg/kg, twice weekly for 4 weeks.

Interventions

  • Ketamine0.5 - 1 mg/kg
    via Other• twice weekly• 8 doses total

    Subcutaneous injection; dose adjustable 0.5–1.0 mg/kg based on response; 2 sessions/week for 4 weeks; monitored during and 3 h after procedure.

Midazolam

inactive

Active placebo comparator: midazolam 1 mg diluted in 5 ml saline, subcutaneous, twice weekly for 4 weeks.

Interventions

  • Placebo1 mg
    via Other• twice weekly• 8 doses total

    Midazolam 1 mg diluted in 5 ml 0.9% saline; active placebo; subcutaneous administration; monitored during and 3 h after procedure.

Participants

Ages
12 – 19
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age between 12 and 19 years.
  • Diagnosis of Major Depressive Episode, unipolar, made through the K-SADS-PL using DSM-5 criteria.
  • Under usual treatment for Major Depressive Episode, including clinically indicated psychopharmacological and/or psychosocial treatment at one of the collaborating clinics.
  • Score ≥ 25 on the MADRS.
  • Score ≥ 28 on the CDRS.
  • 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

  • Exclusion Criteria:
  • Autism Spectrum Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, psychiatric disorder secondary to physical illness.
  • History of ketamine or other substance abuse or dependence in the last 6 months.
  • Intellectual Disability (assessed by IQ testing).
  • 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, CNS tumours, or CNS abnormalities.
  • Previous treatment for depression with esketamine.
  • Allergy to esketamine.
  • If female: pregnancy or breastfeeding.

Study Details

Locations

Brazil

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