A Multicenter, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients with Acute Schizophrenia

OBJECTIVES: PRIMARY: The co-primary objectives of this study were to compare the efficacy of aripiprazole versus olanzapine as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score, and to compare the safety and tolerability of aripiprazole versus olanzapine as evidenced by significant (≥ 7%) weight gain during treatment. SECONDARY: The secondary objectives of this study were to compare the efficacy profiles of aripiprazole versus olanzapine based upon the results of efficacy scales (PANSS, Clinical Global Impression [CGI], and Montgomery-Asberg Depression Rating Scale [MADRS]), and to compare the safety and tolerability of aripiprazole versus olanzapine, and the response rate and discontinuation rate in patients having received aripiprazole versus olanzapine (responders are patients with a CGI Improvement (CGI-I) Score relating to very much or much improved, or with a decrease in PANSS Total Score of at least 30% from baseline). PHARMACOECONOMICS AND OUTCOMES RESEARCH: The objectives of pharmacoeconomics and outcomes research were to compare quality-of-life scores, overall health care resource utilization, and functional outcomes measures between treatment groups. Data from the pharmacoeconomics and outcomes research study will be reported at a later date in an addendum. METHODOLOGY: This was a multicenter, randomized, double-blind, comparative study of aripiprazole (15 - 30 mg) and olanzapine (10 - 20 mg) in patients who were having an acute relapse of schizophrenia.