Bipolar Disorder Mixed Episodes: A Pragmatic Trial of a Public Health Treatment Effectiveness.

OBJECTIVES

To evaluate the effectiveness of an algorithm for the treatment of mixed episodes in bipolar disorder (BD) using the medications available under the Unified Health System (Sistema Único de Saúde) in Brazil.

METHODS

The study included 107 individuals with BD in a current mixed episode, assessed biweekly for the outcomes of response and remission. The subjects were randomly assigned to start treatment with lithium, valproic acid, or carbamazepine, following a clinical protocol at a public outpatient clinic. Eligibility screening instruments, semistructured interview, and clinical psychiatric evaluation were used for diagnosis. To measure response and remission, the Hamilton Rating Scale for Depression and the Young Mania Rating Scale were used. A parameter of 50% or less in the symptom scales was used to define responses, as assessed by Kaplan-Meier time-event analysis.

RESULTS

For the main outcome, response to treatment, all interventions proposed were proven to be effective, with no difference in response time for any of them. There was a lack of placebo control and blinding for intervention or outcomes. Individuals with mixed episodes in BD often face contradictory symptoms, and these inherent difficulties are the main obstacles to stabilize such a condition.

CONCLUSIONS

The findings presented in this study show that the treatments available under the Unified Health System are able to reduce the overall burden of disease in terms of symptom reduction.