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).
Details
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.