Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboUnknown status

Using a Low Dose of Ketamine vs. Active Placebo in Treating Severe Depression and Suicide

Double-blind, randomised, parallel-group trial (n=48) comparing a single 0.5 mg/kg ketamine infusion versus active placebo midazolam 0.045 mg/kg in adults with treatment-resistant depression to assess antidepressant and antisuicidal effects.

Target Enrollment
48 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

This double-blind, randomised, parallel-group study in Taiwan enrols 48 adults with treatment-resistant major depression to compare a single subanaesthetic ketamine infusion (0.5 mg/kg) with an active midazolam placebo (0.045 mg/kg).

Primary outcomes are antidepressant response by MADRS and HAMD ratings and changes in suicide-related symptoms; assessments are conducted from baseline through 14 days post-infusion. The trial builds on prior evidence of rapid antidepressant and antisuicidal effects of ketamine and seeks to validate these effects in a Han Chinese population.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single subanaesthetic ketamine infusion 0.5 mg/kg for TRD.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Single subanaesthetic infusion (0.5 mg/kg).

Midazolam

active comparator

Active placebo midazolam 0.045 mg/kg.

Interventions

  • Placebo0.045 mg/kg
    via IV• single dose• 1 doses total

    Active placebo: midazolam 0.045 mg/kg (Dormicum).

Participants

Ages
20 – 65
Sexes
Male & Female

Inclusion Criteria

  • Major depression including unipolar and bipolar depression, according to DSM-IV criteria and MINI (MiniInternational Neuropsychiatric Interview; MINI) diagnostic interview.
  • Age ≥ 20 years and < 65 years.
  • Voluntary patients with signed informed consent approved by institutional review board (IRB).

Exclusion Criteria

  • Major medical conditions (e.g., head injury, epilepsy, severe renal diseases and cancer).
  • Other axis I psychiatric disorders such as schizophrenia, delusional disorder, organic brain syndrome, and dementia.
  • Pregnancy.
  • Substance abuse in previous 6 months such as cocaine, marijuana, opium, ketamine, PCP (phencyclidine).
  • Current use of NMDA receptor antagonist (Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan).
  • Alcohol abuse or dependence within 6 months.
  • Attempt suicide in hospital.

Study Details

Locations

Taipei Veterans General Hospital — Taipei, Taiwan

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