Randomised, triple-blind, parallel Phase I trial (n=10) comparing ketamine versus placebo for patients with major depressive disorder and inadequate response to antidepressants.
Randomised, triple-masked, parallel-group Phase I study enrolling 10 participants with major depressive disorder (MADRS ≥ 20) and prior inadequate response to at least two antidepressants to compare ketamine with placebo.
Primary purpose is treatment; outcomes and safety assessments follow trial protocol. Eligible and exclusion criteria address psychiatric history, suicide risk, substance use, and contraindications to ketamine.
Active ketamine treatment arm.
Drug: Ketamine
Placebo comparator arm.
Drug: Placebo