Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboUnknown status

Low-Dose Intravenous Ketamine for Adolescents With Depression and Suicidal Ideation in the Emergency Department

Double-blind, randomised, placebo-controlled early Phase I trial (n=30) testing a single low-dose IV ketamine 0.2 mg/kg (min 10 mg, max 20 mg) versus saline in adolescents (12–18) with treatment-resistant depression and suicidal ideation in the emergency department.

Target Enrollment
30 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-blind, placebo-controlled parallel-group trial enrolling adolescents aged 12–18 with treatment-resistant depression and suicidal ideation presenting to the ED; participants randomised 1:1 to ketamine 0.2 mg/kg IV or matched saline.

Study drug given over 2 minutes with vital-sign monitoring before and 5 minutes after infusion and continuous pulse oximetry for 30 minutes; assessments of depression and suicidal ideation at baseline, 1 hour, 3 hours, 1 day, 3 days, and 7 days.

Investigational Drug Service prepares identical syringes; the pharmacist is unmasked to preserve blinding for treating staff, research staff and outcomes assessors are masked.

Study Protocol

Preparation

sessions

Dosing

1 sessions
30 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single low-dose IV ketamine 0.2 mg/kg (min 10 mg, max 20 mg).

Interventions

  • Ketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    Minimum 10 mg, maximum 20 mg; infusion over 2 minutes; nurse remains for 5 minutes; oximetry 30 minutes.

Placebo

inactive

Normal saline in matched syringe (placebo comparator).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Normal saline in matched syringe; prepared by pharmacy to preserve blinding.

Participants

Ages
12 – 18
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Determined, based upon medical and social work evaluation, to require inpatient psychiatric admission without further need for medical diagnostic evaluation and treatment.
  • Treatment-resistant depression (defined as failure of response to trials of at least 2 antidepressant courses, each of at least 4 weeks' duration)
  • Parent/guardian available for consent (in person or by phone)

Exclusion Criteria

  • Exclusion Criteria:
  • Any of the following co-existing diagnoses: primary psychotic disorder (schizophrenia, schizoaffective) autism spectrum disorder, developmental delay/intellectual disability, substance abuse disorder within the last 6 months
  • Aggressive behavior, homicidal ideation
  • Altered mental status
  • Pregnancy or breastfeeding
  • Currently receiving (or receipt within last 24 hours) medication acting on NMDA receptor system (lamotrigine, dextromethorphan, methadone, clarithromycin, amantadine)
  • Incomplete medical evaluation or stabilization
  • Contraindications to or anaphylaxis or prior adverse reaction to Ketamine
  • No caregiver available
  • In custody of a law enforcement agency

Study Details

Locations

Rady Children's Hospital San Diego — San Diego, California, United States

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