WEDNESDAY, Dec. 23 (HealthDay News) -- Bipolar disorder patients are less likely to have a relapse if they take lithium monotherapy or lithium combined with valproate than if they take valproate alone, but there is no evidence to support the use of combination therapy over lithium alone, according to a study published online Dec. 23 in The Lancet.
John R. Geddes, M.D., of the University of Oxford in the United Kingdom, and colleagues conducted a study of 330 patients with bipolar disorder, aged 16 years and above, recruited from 41 sites in France, Italy, the United Kingdom and the United States, of whom 110 were each randomized to receive valproate monotherapy, lithium monotherapy, or a combination of the two. The patients were followed up for 24 months.
The primary outcome was intention to treat for relapse, which occurred in 54 percent of the combination-therapy group, 59 percent of the lithium group and 69 percent of the valproate group, the investigators discovered. The severity of illness did not have an impact on the risk of relapse, and there were 16 adverse events in the study cohort, including six deaths, the researchers found.
"Our results suggest that patients should be advised that a better outcome would be likely with combination therapy with lithium plus valproate semisodium or lithium alone," the authors write.
The study was funded by the Stanley Medical Research Institute and Sanofi-Aventis.