Clinical TrialTreatment-Resistant Depression (TRD)PlaceboPlaceboKetamineKetamineCompleted

Low-dose Ketamine Infusion Among Adolescents With Treatment-resistant Depression

Randomised, double-blind, parallel-group trial (n=12 actual) testing IV low-dose ketamine 0.5 mg/kg versus active placebo (midazolam 0.045 mg/kg) in adolescents (13–19) with treatment-resistant depression.

Target Enrollment
12 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

Rationale: adolescent treatment-resistant depression is common and associated with high suicidal risk; low-dose ketamine has rapid antidepressant effects in adults and is being evaluated here in adolescents.

Design: randomised, double-blind, parallel-group trial comparing active placebo midazolam (0.045 mg/kg) and ketamine (0.5 mg/kg) across two infusion sessions (Day 1 and Day 3); primary purpose is treatment.

Outcomes and population: efficacy and safety in adolescents aged 13–19 with TRD, with clinical assessments and follow-up per protocol; actual registry count indicates 12 participants to date.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Midazolam x2

active comparator

Two 0.045 mg/kg midazolam infusions (active placebo) on Day 1 and Day 3.

Interventions

  • Placebo0.045 mg/kg
    via IV• two sessions• 2 doses total

    Two 0.045 mg/kg infusions on Day 1 and Day 3 (active placebo).

Midazolam→Ketamine

experimental

First 0.045 mg/kg midazolam infusion and second 0.5 mg/kg ketamine infusion (crossover of infusions across sessions).

Interventions

  • Placebo0.045 mg/kg
    via IV• two sessions• 1 doses total

    Day 1: midazolam 0.045 mg/kg.

  • Ketamine0.5 mg/kg
    via IV• two sessions• 1 doses total

    Day 3: ketamine 0.5 mg/kg.

Ketamine x2

experimental

Two 0.5 mg/kg ketamine infusions.

Interventions

  • Ketamine0.5 mg/kg
    via IV• two sessions• 2 doses total

    Two 0.5 mg/kg infusions (Day 1 and Day 3).

Participants

Ages
13 – 19
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n1. Major depressive episode including unipolar and bipolar depression, according to DSM-5 criteria and MINI-adolescent version (Mini-International Neuropsychiatric Interview; MINI) diagnostic interview.\n2. Age 13 to 19 years old.\n3. Body weigh ≧ 30 kg.\n4. Treatment-resistant depression, which is defined as poor or unsatisfactory response to at least two different antidepressants administered at an adequate dosage and for an adequate treatment duration\n5. Still prominent depressive symptoms with at least 4-week treatment of medication treatment or psychotherapy\n6. Voluntary patients and their parents or guardians with signed informed consent proved by institutional review board (IRB)

Exclusion Criteria

  • Exclusion Criteria:\n\n1. Major medical conditions (e.g., head injury, epilepsy, severe renal diseases and cancer).\n2. Other axis I psychiatric disorders such as schizophrenia, delusional disorder, organic brain syndrome, and dementia.\n3. Pregnancy.\n4. Substance abuse in previous 6 months such as cocaine, marijuana, opium, ketamine, PCP (phencyclidine)。\n5. Current use of NMDA receptor antagonist (Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan)\n6. Alcohol abuse / dependence within 6 months.\n7. Attempt suicide in hospital.\n8. Allergy to ketamine\n9. Abnormal liver function in recent 3 months。\n10. Abnormal ECG (i.e.:arrhythmia)。\n11. Fever or infection in recent 5 days。

Study Details

Locations

Taipei Veterans General Hospital, Taiwan — Taipei, Taiwan

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