Intravenous ketamine for Treatment Resistant Depression: Exploring biomarkers of response and relapse A double-blind, randomized controlled trial
Double-blind, randomised, placebo-controlled Phase II trial (n=120) evaluating a single intravenous ketamine infusion versus placebo in patients with treatment-resistant depression and bipolar depression, with biomarker and relapse endpoints.
Details
Randomised, double-blind, parallel-group study comparing intravenous ketamine (Ketalar) to placebo in adults with treatment-resistant major depressive disorder or bipolar depression; designed to replicate ketamine efficacy and identify biomarkers of response and relapse.
Primary efficacy assessments occur at screening/day 1, after the IV ketamine injection (day 8), final visit (day 15) and follow-up (day 21). Secondary measures include experience sampling, biomarkers predictive of response and relapse, and psychophysiology of stress.