Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Chinese subpopulation analysis of a double-blind, randomized, placebo-controlled study

Gang Wang,1–3 Yan Cheng,4 Jia Ning Wang,4 Sheng Hu Wu4 Hai Bo Xue5 1Mood Disorders Center, Beijing Anding Hospital, Capital Medical University, Beijing, People’s Republic of China; 2China Clinical Research Center for Mental Disorders, Beijing, People’s Republic of Chin...

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Autores principales:	Wang G, Cheng Y, Wang JN, Wu SH, Xue HB
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	Bipolar disorder Chinese Depression Olanzapine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/60aabce15e8744359ce9f76804d52041
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spelling	oai:doaj.org-article:60aabce15e8744359ce9f76804d520412021-12-02T04:13:33ZEfficacy and safety of olanzapine for treatment of patients with bipolar depression: Chinese subpopulation analysis of a double-blind, randomized, placebo-controlled study1178-2021https://doaj.org/article/60aabce15e8744359ce9f76804d520412016-08-01T00:00:00Zhttps://www.dovepress.com/efficacy-and-safety-of-olanzapine-for-treatment-of-patients-with-bipol-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Gang Wang,1–3 Yan Cheng,4 Jia Ning Wang,4 Sheng Hu Wu4 Hai Bo Xue5 1Mood Disorders Center, Beijing Anding Hospital, Capital Medical University, Beijing, People’s Republic of China; 2China Clinical Research Center for Mental Disorders, Beijing, People’s Republic of China; 3Center of Depression, Beijing Institute for Brain Disorders, Beijing, People’s Republic of China; 4Lilly Suzhou Pharmaceutical Co., Ltd., Shanghai, People’s Republic of China; 5UCB (Zhuhai) Pharma Co., Ltd., Shanghai, People’s Republic of China Background: Depression in bipolar I disorder responds to the atypical antipsychotic olanzapine. This subpopulation analysis assessed whether olanzapine is superior to placebo specifically in the treatment of Chinese patients with bipolar I depression.Methods: This was a subpopulation analysis of a 6-week, multicenter, double-blind, parallel, randomized, placebo-controlled trial among 12 Chinese study centers. Eligible inpatients and outpatients were randomized to olanzapine (5 to 20 mg/day) or placebo. Patients were primarily assessed by the Montgomery-Åsberg Depression Rating Scale total score. Secondary assessments used a range of other efficacy and safety measures. This subpopulation analysis was underpowered to show statistically significant differences between treatment groups.Results: In total, 210 patients (mean age 32.9 years at baseline, 54.3% females) were randomized. Similar proportions of patients treated with olanzapine (75.0%) and placebo (72.9%) completed the double-blind phase. Baseline-to-endpoint least-squares mean ± standard error decrease in the Montgomery-Åsberg Depression Rating Scale total score in the olanzapine group (-13.55±0.80) was similar to that noted in the parent trial (-13.82±0.65). However, the difference between olanzapine and placebo groups was not statistically significant (P=0.44); this finding was also true for the secondary efficacy measures. A post hoc analysis showed a greater emergence of mania in the placebo group, which likely reduced the treatment difference between olanzapine and placebo in the primary efficacy measure. Safety data were consistent with the known safety profile of olanzapine, including a higher incidence of weight gain (≥7%) in the olanzapine group (24.1% vs 1.4%, P<0.001).Conclusion: Olanzapine provides similar improvement in depression among Chinese and non-Chinese bipolar I patients. The lack of a statistically significant difference between the olanzapine and placebo groups in this Chinese subpopulation analysis may relate to an a priori lack of study power, and underestimation of the effect of olanzapine because of a greater emergence of mania in placebo-treated patients and missing data associated with a high early discontinuation rate. Keywords: bipolar disorder, Chinese, depression, olanzapineWang GCheng YWang JNWu SHXue HBDove Medical PressarticleBipolar disorderChineseDepressionOlanzapineNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 12, Pp 2077-2087 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	Bipolar disorder Chinese Depression Olanzapine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Bipolar disorder Chinese Depression Olanzapine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Wang G Cheng Y Wang JN Wu SH Xue HB Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Chinese subpopulation analysis of a double-blind, randomized, placebo-controlled study
description	Gang Wang,1–3 Yan Cheng,4 Jia Ning Wang,4 Sheng Hu Wu4 Hai Bo Xue5 1Mood Disorders Center, Beijing Anding Hospital, Capital Medical University, Beijing, People’s Republic of China; 2China Clinical Research Center for Mental Disorders, Beijing, People’s Republic of China; 3Center of Depression, Beijing Institute for Brain Disorders, Beijing, People’s Republic of China; 4Lilly Suzhou Pharmaceutical Co., Ltd., Shanghai, People’s Republic of China; 5UCB (Zhuhai) Pharma Co., Ltd., Shanghai, People’s Republic of China Background: Depression in bipolar I disorder responds to the atypical antipsychotic olanzapine. This subpopulation analysis assessed whether olanzapine is superior to placebo specifically in the treatment of Chinese patients with bipolar I depression.Methods: This was a subpopulation analysis of a 6-week, multicenter, double-blind, parallel, randomized, placebo-controlled trial among 12 Chinese study centers. Eligible inpatients and outpatients were randomized to olanzapine (5 to 20 mg/day) or placebo. Patients were primarily assessed by the Montgomery-Åsberg Depression Rating Scale total score. Secondary assessments used a range of other efficacy and safety measures. This subpopulation analysis was underpowered to show statistically significant differences between treatment groups.Results: In total, 210 patients (mean age 32.9 years at baseline, 54.3% females) were randomized. Similar proportions of patients treated with olanzapine (75.0%) and placebo (72.9%) completed the double-blind phase. Baseline-to-endpoint least-squares mean ± standard error decrease in the Montgomery-Åsberg Depression Rating Scale total score in the olanzapine group (-13.55±0.80) was similar to that noted in the parent trial (-13.82±0.65). However, the difference between olanzapine and placebo groups was not statistically significant (P=0.44); this finding was also true for the secondary efficacy measures. A post hoc analysis showed a greater emergence of mania in the placebo group, which likely reduced the treatment difference between olanzapine and placebo in the primary efficacy measure. Safety data were consistent with the known safety profile of olanzapine, including a higher incidence of weight gain (≥7%) in the olanzapine group (24.1% vs 1.4%, P<0.001).Conclusion: Olanzapine provides similar improvement in depression among Chinese and non-Chinese bipolar I patients. The lack of a statistically significant difference between the olanzapine and placebo groups in this Chinese subpopulation analysis may relate to an a priori lack of study power, and underestimation of the effect of olanzapine because of a greater emergence of mania in placebo-treated patients and missing data associated with a high early discontinuation rate. Keywords: bipolar disorder, Chinese, depression, olanzapine
format	article
author	Wang G Cheng Y Wang JN Wu SH Xue HB
author_facet	Wang G Cheng Y Wang JN Wu SH Xue HB
author_sort	Wang G
title	Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Chinese subpopulation analysis of a double-blind, randomized, placebo-controlled study
title_short	Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Chinese subpopulation analysis of a double-blind, randomized, placebo-controlled study
title_full	Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Chinese subpopulation analysis of a double-blind, randomized, placebo-controlled study
title_fullStr	Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Chinese subpopulation analysis of a double-blind, randomized, placebo-controlled study
title_full_unstemmed	Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Chinese subpopulation analysis of a double-blind, randomized, placebo-controlled study
title_sort	efficacy and safety of olanzapine for treatment of patients with bipolar depression: chinese subpopulation analysis of a double-blind, randomized, placebo-controlled study
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/60aabce15e8744359ce9f76804d52041
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Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Chinese subpopulation analysis of a double-blind, randomized, placebo-controlled study

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