Clinical TrialDepressive DisordersKetaminePlaceboNot yet recruiting

Ketamine for Combined Depression and Alcohol Use Disorder (KeDA)

This triple-blinded, randomised, active placebo-controlled trial (n=34) will investigate IV ketamine (0.8 mg/kg, four infusions over two weeks) versus midazolam in adults with moderate depression and alcohol use disorder admitted for inpatient addiction therapy.

Target Enrollment
34 participants
Study Type
Phase I/II interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-blind, parallel-group trial (n=34) comparing IV ketamine 0.8 mg/kg to active placebo midazolam 0.02 mg/kg; four infusions given twice weekly over two weeks alongside standard inpatient addiction therapy.

Primary and secondary outcomes include depressive symptoms (MADRS, BDI-II), alcohol use and craving (TLFB, ACQ-Short, PACS), neurocognitive function (CANTAB), safety/tolerability (mKSET, AEs/SAEs) and exploratory measures of quality of life and subjective experience (MEQ30, EDI, EBI).

Assessments occur at baseline, acutely and at multiple follow-ups (1–2 days, 1 week, 2 weeks, 4 weeks) with a final follow-up at 6 months to evaluate lasting effects on depression and alcohol use disorder.

Study Protocol

Preparation

sessions

Dosing

4 sessions
40 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine

experimental

IV ketamine infusions 0.8 mg/kg given twice weekly for two weeks (four total infusions).

Interventions

  • Ketamine0.8 mg/kg
    via IV• four doses (twice weekly for 2 weeks)• 4 doses total

    IV infusions over 40 minutes

Midazolam

active comparator

Active placebo: IV midazolam 0.02 mg/kg given on same schedule as ketamine.

Interventions

  • Placebo0.02 mg/kg
    via IV• four doses (twice weekly for 2 weeks)• 4 doses total

    Midazolam 0.02 mg/kg IV over 40 minutes (active comparator)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Currently abstinent from alcohol
  • At least moderate depression without psychotic features
  • Minimum Montgomery-Åsberg Depression Rating Scale (MADRS) of 20
  • Alcohol dependence
  • Admitted for inpatient addiction therapy at University Hospital of North Norway

Exclusion Criteria

  • Intoxicated or in significant withdrawal from alcohol or drug use
  • Not able to give adequate informed consent
  • Current or past history of schizophrenia, schizophreniform disorder, paranoid delusional disorder, schizoaffective disorder
  • Current or historical diagnosis of schizophrenia in a first degree relative
  • Cardiovascular conditions: recent stroke (< 1 year from informed consent), recent myocardial infarction (< 1 year from informed consent), uncontrolled hypertension (>150/100 mm Hg) or recent arrhythmia (< 1 year from informed consent; clinically significant arrhythmia requiring treatment at hospital)
  • Liver (Child-Pugh Class C) or kidney (Creatinine clearance < 30 mL/min) failure
  • Heart failure (NYHA class III or IV)
  • Chronic respiratory failure (requiring long-term oxygen therapy and/or GOLD stage 3 or higher)
  • Previous anaphylactic reaction to ketamine or midazolam
  • Illegal use of ketamine the last 6 months
  • Pregnancy or breastfeeding
  • Current or suspected increased intracranial pressure

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment34 participants
  • Timeline
    Start: 2024-01-01
    End: 2027-07-01
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Norway

Your Library