This randomised, double-blind, placebo-controlled trial (n=26) aims to investigate the safety and efficacy of ketamine and riluzole in patients with treatment-resistant major depressive disorder. Additionally, the study will assess whether lamotrigine can mitigate ketamine-associated side effects.
Randomised, double‑blind, factorial study (n=26) evaluating whether lamotrigine pre‑treatment (300 mg, 2 h prior) modifies acute response to a single IV subanesthetic racemic ketamine infusion in treatment‑resistant major depressive disorder; responders entered a 4‑week randomized continuation to riluzole 100 mg/day or placebo.
Primary outcomes include safety and efficacy measures; design includes a pre‑treatment (lamotrigine vs placebo) and a continuation phase (riluzole vs matching placebo) in ketamine responders.
Lamotrigine 300 mg given 2 h prior to ketamine; responders randomised to riluzole or placebo for 4 weeks.
Lamotrigine 300 mg given 2 hours prior to ketamine.
Single subanesthetic IV racemic ketamine (infusion details not specified).
Riluzole 100 mg/day (two 50 mg capsules) given in the 4-week continuation phase for responders; randomised vs matching placebo.
Placebo pre-treatment 2 h prior to ketamine; responders randomised to riluzole or placebo for 4 weeks.
Three capsules matching lamotrigine given 2 hours prior to ketamine.
Single subanesthetic IV racemic ketamine (infusion details not specified).
Riluzole 100 mg/day (two 50 mg capsules) given in the 4-week continuation phase for responders; randomised vs matching placebo.