Mauricio Tohen1, Roger S McIntyre2, Shigenobu Kanba3, Shinji Fujikoshi4, Hideaki Katagiri5. 1. University of New Mexico, Health Sciences Center, Department of Psychiatry, Albuquerque, NM, USA. 2. University of Toronto, Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Canada. 3. Kyushu University, Department of Neuropsychiatry, Fukuoka, Japan; East Asian Bipolar Forum, Fukuoka, Japan. 4. Eli Lilly Japan K.K., Lilly Research Laboratories, Statistical Science, Kobe, Japan. 5. Eli Lilly Japan K.K., Lilly Research Laboratories, Medical Science, Sannomiya Plaza Building, 7-1-5, Isogamidori, Chuo-ku, Kobe 651-0086, Japan. Electronic address: katagiri_hideaki@lilly.com.
Abstract
BACKGROUND: These analyses compared efficacy of olanzapine in patients with bipolar mania with or without mixed features, as defined in the DSM-5. METHODS: Pooled data from 3 placebo-controlled olanzapine studies in patients having bipolar I disorder with manic/mixed episode were analyzed (N=228olanzapine; N=219 placebo). Patients were categorized for mixed features by number of concurrent depressive symptoms at baseline (0, 1, and 2 [category A; without mixed features], and ≥3 [category B; with mixed features]), as determined by HAM-D17 item score ≥1. Depressive symptoms corresponded to 6 HAM-D17 items in the DSM-5 definition of manic episode with mixed features. Primary efficacy was evaluated by changes in the baseline-to-3-week YMRS total score. RESULTS: Patients were categorized into A (N=322; 72.0%) or B (N=125; 28.0%). Mean baseline YMRS total scores were 28.1 in category A and 27.8 in category B. Least-squares mean change of YMRS total scores in categories A and B (olanzapine versus placebo) were -11.78 versus -6.86 and -13.21 versus -4.72, respectively. Patients in the olanzapine- compared with placebo-group experienced a greater decrease in YMRS total score for both categories (p<0.001). An interaction between mixed features and treatment was seen in YMRS change at a 0.3 significance level (p=0.175). LIMITATIONS: The results are from post-hoc analyses. CONCLUSIONS:Olanzapine was efficacious in the treatment of bipolar I mania, in patients both with and without mixed features, defined by DSM-5; however, greater efficacy was observed in patients with mixed features having more severe depressive symptoms.
RCT Entities:
BACKGROUND: These analyses compared efficacy of olanzapine in patients with bipolar mania with or without mixed features, as defined in the DSM-5. METHODS: Pooled data from 3 placebo-controlled olanzapine studies in patients having bipolar I disorder with manic/mixed episode were analyzed (N=228 olanzapine; N=219 placebo). Patients were categorized for mixed features by number of concurrent depressive symptoms at baseline (0, 1, and 2 [category A; without mixed features], and ≥3 [category B; with mixed features]), as determined by HAM-D17 item score ≥1. Depressive symptoms corresponded to 6 HAM-D17 items in the DSM-5 definition of manic episode with mixed features. Primary efficacy was evaluated by changes in the baseline-to-3-week YMRS total score. RESULTS:Patients were categorized into A (N=322; 72.0%) or B (N=125; 28.0%). Mean baseline YMRS total scores were 28.1 in category A and 27.8 in category B. Least-squares mean change of YMRS total scores in categories A and B (olanzapine versus placebo) were -11.78 versus -6.86 and -13.21 versus -4.72, respectively. Patients in the olanzapine- compared with placebo-group experienced a greater decrease in YMRS total score for both categories (p<0.001). An interaction between mixed features and treatment was seen in YMRS change at a 0.3 significance level (p=0.175). LIMITATIONS: The results are from post-hoc analyses. CONCLUSIONS:Olanzapine was efficacious in the treatment of bipolar I mania, in patients both with and without mixed features, defined by DSM-5; however, greater efficacy was observed in patients with mixed features having more severe depressive symptoms.