Estudio Aleatorizado, Multicéntrico, para Comparar la Eficacia y Seguridad del Fumarato De Quetiapina de Liberación Prolongada como Monoterapia o en Combinación con Litio en el Tratamiento de Pacientes Con Depresión Bipolar Aguda

Abstract

Objective: The main purpose of this work is to demonstrate that Quetiapine used in monotherapy once daily is not inferior to the combination of Quetiapine once daily with Lithium twice a day. Method: 88 patients, male and female, 18 to 65 years old, with a diagnostic of Bipolar disorder I or II by DSM-IV, with at least one recent and confirmed mayor depression episode, shorter than year but longer than two weeks. Patients were randomized in two treatment branches Quetiapina (50 mg o 100 mg o 200 mg o 300 mg) or combined treatment of Quetiapine with Lithium twice a day (300 mg/day to 1800 mg/day). The primary efficacy measure was mean change from baseline to week 8 in the Montgomery-Åsberg Depression Rating Scale total score. Additional efficacy assessments included the Hamilton Depression Rating Scale. Results: Both treatments demonstrated an improvement in the total score for MADRS and HAM-D scales. It´s demonstrated statistically, through the t-student, that the improvement in patients condition treated with Quetiapine monotherapy is not inferior to the improvement observed with the combine therapy with lithium twice a day. Conclusions: The monotherapy with Quetiapine is not inferior to the therapy of Quetiapina combined with Lithium in the treatment of Mayor Depression