Randomised, triple-blind, parallel trial (n=0) comparing lithium versus placebo given for 2 weeks prior to three IV ketamine infusions (0.5 mg/kg over 100 minutes) in adults with treatment-resistant depression.
Participants are randomised to receive lithium or matching placebo for two weeks prior to an acute course of three intravenous ketamine infusions (0.5 mg/kg each, over 100 minutes across 7 days). Lithium/placebo is continued in a double-blind fashion during the acute ketamine phase.
Questionnaires and rating scales are administered at baseline, before each infusion, at 40, 100 and 120 minutes after each infusion, and weekly for 4 weeks after the third infusion; responders (>50% reduction in score) may receive four additional once-weekly ketamine infusions.
Lithium started 2 weeks before first ketamine infusion and continued during acute phase; all subjects receive three IV ketamine infusions (0.5 mg/kg over 100 min) over 7 days; responders may receive 4 additional weekly infusions.
Lithium titrated to serum level ≥0.4 mEq/L; started 2 weeks pre-ketamine and continued during acute phase.
Each infusion 0.5 mg/kg over 100 minutes; responders receive 4 additional once-weekly infusions.
Matching placebo tablets started 2 weeks before first ketamine infusion and continued during acute phase; all subjects receive three IV ketamine infusions (0.5 mg/kg over 100 min) over 7 days.
Matching placebo tablets started 2 weeks pre-ketamine and continued during acute phase.
Each infusion 0.5 mg/kg over 100 minutes; responders receive 4 additional once-weekly infusions.