The FDA is reviewing 3 controlled trials of lumateperone (Caplyta) in bipolar depression. The results have not been published, but their bare bones have been presented at conferences. Here is what we know so far.
All 3 were large, randomized, placebo controlled, quadruple-blind trials in bipolar I and bipolar II depression. The first trial was negative, but lumateperone worked in the next 2 with a small to medium effect size (0.27-0.56). As with other atypicals in bipolar depression, lumateperone’s efficacy was evident as early as week 1