Continuation Ketamine in Major Depression
As of May 21st, 2012, the purpose of this study is to test the antidepressant effect of ketamine when given repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention strategy for patients with treatment-resistant depression (TRD) who respond to an initial series of ketamine infusions.
Details
Phase I add-on design in adults with treatment-resistant major depression. All participants receive IV ketamine 0.5 mg/kg in a repeated one-week infusion series; the continuation phase compares lithium carbonate (600–900 mg) versus placebo to evaluate relapse prevention after initial ketamine response.
ClinicalTrials.gov lists quadruple masking with non-randomised parallel assignment. Both arms include ketamine; the adjunct is lithium or placebo. Planned/actual sample size n=36; single site at Mount Sinai, New York.