Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboNot yet recruiting

Pilot study for the rapid alleviation of depression in depressed alcohol dependent persons using ketamine

This randomised controlled trial (n=24) investigates the rapid alleviation of depression in individuals with coexisting alcohol dependence (AUD), utilising ketamine at sub-anaesthetic doses (7-140mg/70kg intramuscular).

Target Enrollment
24 participants
Study Type
Phase II/III interventional
Design
Randomized, single Blind

Detailed Description

Randomised, blinded, crossover Phase II/III study in 24 participants with major depression and alcohol dependence, testing ascending intramuscular ketamine doses versus saline placebo.

Each subject receives four blinded IM infusions approximately 7 days apart (placebo randomly inserted); cohort 1 doses 0.1, 0.25, 0.5 mg/kg; cohort 2 doses 0.5, 1, 2 mg/kg. Primary outcome is remission by MADRS <7; safety/tolerability assessed by self-report and medication side-effects interview at baseline and multiple post-infusion timepoints up to 168 hours.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Ascending-dose, within-subject crossover with placebo; two cohorts with different escalation ranges.

Interventions

  • Ketamine0.1 - 2 mg/kg
    via IM• four infusions• 4 doses total

    Cohort 1: 0.1, 0.25, 0.5 mg/kg; Cohort 2: 0.5, 1, 2 mg/kg; ascending-dose subject to safety; placebo randomly inserted into sequence.

  • Placebo1 ml
    via IM• four infusions

    Saline 0.9% IM bolus 1 ml as placebo, randomly inserted.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • DSM-IV-TR alcohol dependence; major depression with Montgomery-Asberg Depression Rating Scale (MADRS) score >20; able and willing to give informed consent.

Exclusion Criteria

  • Current chaotic multiple substance use (excluding alcohol and tobacco); currently in active moderate to severe alcohol withdrawal; actively suicidal or homicidal; pregnancy, nursing or refusal to use reliable birth control (females); severe psychiatric symptoms requiring likely hospitalisation; evidence of significant cerebral, renal, thyroid or cardiac disease; severe liver disease or liver failure. Disallowed medications: lamotrigine, memantine, amantadine, riluzole, N-acetylcysteine within 2 weeks; MAOIs within 4 weeks; escalating doses of opioids.

Study Details

Locations

Unknown facility — Australia

Your Library