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Standard and Higher Dose of Olanzapine in Patients With Schizophrenia or Schizoaffective Disorder

2008; Lippincott Williams & Wilkins; Volume: 28; Issue: 4 Linguagem: Inglês

10.1097/jcp.0b013e31817e63a5

1533-712X

Bruce J. Kinon, Jan Volavka, Virginia L. Stauffer, Sara Edwards, Hong Liu‐Seifert, Lei Chen, David H. Adams, Jean-Pierre Lindenmayer, Joseph P. McEvoy, P.F. Buckley, Jeffrey A. Lieberman, Herbert Y. Meltzer, Daniel R. Wilson, Leslie Citrome,

Treatment of Major Depression

The objective of this study was to assess the dose-response relationship of standard and higher doses of olanzapine in a randomized, double-blind, 8-week, fixed-dose study comparing olanzapine 10 (n = 199), 20 (n = 200), and 40 mg/d (n = 200) for patients with schizophrenia or schizoaffective disorder and suboptimal response to current treatment. Patients meeting criteria for antipsychotic treatment resistance were excluded. Dose-response relationship was assessed by linear regression analysis with log-transformed dose (independent variable) and Positive and Negative Syndrome Scale (PANSS) total score (dependent variable). There were no significant dose group differences in patients completing the study (overall, 67.8%). All dose groups showed statistically significant improvement in PANSS total scores from baseline to end point without significant dose-response relationship (P = 0.295). Post hoc analysis of response showed significant interaction between baseline PANSS and dose (P = 0.023), indicating better response at higher doses for patients with higher baseline PANSS. There was a significant dose response for mean change in weight (P = 0.003) with significant difference between the 10- and 40-mg-dose groups (P = 0.002; 1.9 [10 mg/d], 2.3 [20 mg/d], and 3.0 kg [40 mg/d]). There was a significant dose response for change in prolactin (P < 0.001) with a significant difference between each group (−10.5 [10 mg/d], −1.7 [20 mg/d], and 4.9 ng/mL [40 mg/d]; P ≤ 0.018). Over 8 weeks, non-treatment-resistant patients with schizophrenia or schizoaffective disorder responded to all 3 doses of olanzapine, without a statistically significant dose-response relationship, suggesting that for many patients with schizophrenia or schizoaffective disorder, particularly those who are mildly or moderately ill, 10 mg/d should be the initial dose of choice.