Clinical TrialDepressive DisordersKetaminePlaceboCompleted

Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

This double-blind, placebo-controlled trial (n=24) aims to evaluate the effectiveness of ketamine treatment compared to midazolam over three consecutive days in patients with difficult-to-treat depression.

Target Enrollment
24 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel-group trial in adults with depression (MADRS ≥25) comparing IV ketamine 0.5 mg/kg (40-minute infusion) versus midazolam 0.045 mg/kg, administered once daily for three consecutive days; primary outcomes include change in MADRS with follow-up at 1 and 4 weeks.

Safety and secondary measures include vital signs, dissociative symptoms, CGI and EQ-5D-5L; eligibility requires prior adequate trials of antidepressants and psychotherapy and excludes recent substance use disorder, psychosis, bipolar disorder, pregnancy and several serious medical conditions.

Study Protocol

Preparation

sessions

Dosing

3 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

IV ketamine 0.5 mg/kg infused over 40 minutes once daily for 3 consecutive days.

Interventions

  • Ketamine0.5 mg/kg
    via IV• daily for 3 days• 3 doses total

    40-minute infusion per session

Midazolam

active comparator

IV midazolam 0.045 mg/kg infused over 40 minutes once daily for 3 consecutive days (placebo comparator per registry).

Interventions

  • Placebo0.045 mg/kg
    via IV• daily for 3 days• 3 doses total

    Midazolam 0.045 mg/kg; 40-minute infusion

Participants

Ages
20 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Over 20 years old
  • Depression diagnosed by a psychiatrist and MADRS >= 25
  • Failed to improve after optimal dosage of two antidepressants for 4 weeks and one psychotherapy
  • Stable dosage of current medications for 4 weeks
  • Fluent in Thai

Exclusion Criteria

  • Exclusion Criteria:
  • Secondary depression
  • PTSD
  • Current pregnancy
  • History of increased intracranial hemorrhage, increased intracranial pressure, severe head injury, abnormal thyroid function, angina, heart failure, arrhythmia, aneurysm, uncontrolled hypertension, chronic lower tract respiratory disease, myasthenia gravis, glaucoma, dementia, acute porphyria, or cystitic within 3 months prior to recruitment
  • Allergy to ketamine or midazolam
  • History of substance use disorder within 1 year prior to recruitment
  • History of psychosis within 3 months
  • History of bipolar disorder
  • BMI over 35
  • Frail medical condition
  • Currently receiving ECT or TMS

Study Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2021-09-01
    End: 2022-07-31
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Keerati Pattanaseri — Bangkok, Thailand

Your Library