Multi-center, randomized, double-blind, placebo-controlled study of quetiapine extended-release formulation in Japanese patients with bipolar depression

Mitsukuni Murasaki, Tsukasa Koyama, Shigenobu Kanba, Masahiro Takeuchi, Yuriko Shimizu, Eri Arita, Kentaro Kuroishi, Masahiro Takeuchi, Shinya Kamei

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Rationale: Quetiapine fumarate is an atypical antipsychotic indicated for various mental disorders, but it has not been studied in Japanese patients with bipolar depression. Objectives: To evaluate the efficacy and safety of quetiapine XR (extended release) in Japanese patients with bipolar depression. Methods: In this multi-center, randomized, double-blind, placebo-controlled, fixed-dose study of 431 Japanese adults with bipolar I or II disorder, efficacy was determined by analyzing the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Secondary end points included MADRS response and remission rates, Hamilton Depression Scale 17-Item (HAM-D17), and Clinical Global Impressions-Bipolar (CGI-BP) scale scores. Safety was determined by monitoring adverse events and clinical assessments. Results: This study revealed a statistically significantly greater decrease in MADRS total score after 8 weeks of quetiapine XR 300 mg/day monotherapy compared with placebo (− 12.6 vs. − 10.1; p = 0.034). There were also improvements in MADRS response (44.1 vs. 35.6%) and remission (38.0 vs. 26.6%) rates as well as in HAM-D17 and CGI-BP scale scores compared with placebo. In the subgroup analysis of patients with bipolar I or II disorder, the adjusted mean changes in MADRS total score compared to placebo were − 2.3 and − 2.1, respectively. Adverse events occurred in 149 patients (83.2%) receiving quetiapine XR 300 mg/day and in 81 patients (45.8%) receiving placebo. The most common adverse events were somnolence and thirst, which is consistent with the previously reported safety profile. Conclusions: Once-daily monotherapy with quetiapine XR is an effective and well-tolerated treatment for bipolar depression in Japanese patients.

Original languageEnglish
Pages (from-to)2859-2869
Number of pages11
JournalPsychopharmacology
Volume235
Issue number10
DOIs
Publication statusPublished - Oct 1 2018

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Bipolar Disorder
Placebos
Depression
Safety
Thirst
Mental Disorders
Antipsychotic Agents
Quetiapine Fumarate

All Science Journal Classification (ASJC) codes

  • Pharmacology

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Multi-center, randomized, double-blind, placebo-controlled study of quetiapine extended-release formulation in Japanese patients with bipolar depression. / Murasaki, Mitsukuni; Koyama, Tsukasa; Kanba, Shigenobu; Takeuchi, Masahiro; Shimizu, Yuriko; Arita, Eri; Kuroishi, Kentaro; Takeuchi, Masahiro; Kamei, Shinya.

In: Psychopharmacology, Vol. 235, No. 10, 01.10.2018, p. 2859-2869.

Research output: Contribution to journalArticle

Murasaki, M, Koyama, T, Kanba, S, Takeuchi, M, Shimizu, Y, Arita, E, Kuroishi, K, Takeuchi, M & Kamei, S 2018, 'Multi-center, randomized, double-blind, placebo-controlled study of quetiapine extended-release formulation in Japanese patients with bipolar depression', Psychopharmacology, vol. 235, no. 10, pp. 2859-2869. https://doi.org/10.1007/s00213-018-4977-6
Murasaki, Mitsukuni ; Koyama, Tsukasa ; Kanba, Shigenobu ; Takeuchi, Masahiro ; Shimizu, Yuriko ; Arita, Eri ; Kuroishi, Kentaro ; Takeuchi, Masahiro ; Kamei, Shinya. / Multi-center, randomized, double-blind, placebo-controlled study of quetiapine extended-release formulation in Japanese patients with bipolar depression. In: Psychopharmacology. 2018 ; Vol. 235, No. 10. pp. 2859-2869.
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abstract = "Rationale: Quetiapine fumarate is an atypical antipsychotic indicated for various mental disorders, but it has not been studied in Japanese patients with bipolar depression. Objectives: To evaluate the efficacy and safety of quetiapine XR (extended release) in Japanese patients with bipolar depression. Methods: In this multi-center, randomized, double-blind, placebo-controlled, fixed-dose study of 431 Japanese adults with bipolar I or II disorder, efficacy was determined by analyzing the mean change from baseline in Montgomery-{\AA}sberg Depression Rating Scale (MADRS) total score. Secondary end points included MADRS response and remission rates, Hamilton Depression Scale 17-Item (HAM-D17), and Clinical Global Impressions-Bipolar (CGI-BP) scale scores. Safety was determined by monitoring adverse events and clinical assessments. Results: This study revealed a statistically significantly greater decrease in MADRS total score after 8 weeks of quetiapine XR 300 mg/day monotherapy compared with placebo (− 12.6 vs. − 10.1; p = 0.034). There were also improvements in MADRS response (44.1 vs. 35.6{\%}) and remission (38.0 vs. 26.6{\%}) rates as well as in HAM-D17 and CGI-BP scale scores compared with placebo. In the subgroup analysis of patients with bipolar I or II disorder, the adjusted mean changes in MADRS total score compared to placebo were − 2.3 and − 2.1, respectively. Adverse events occurred in 149 patients (83.2{\%}) receiving quetiapine XR 300 mg/day and in 81 patients (45.8{\%}) receiving placebo. The most common adverse events were somnolence and thirst, which is consistent with the previously reported safety profile. Conclusions: Once-daily monotherapy with quetiapine XR is an effective and well-tolerated treatment for bipolar depression in Japanese patients.",
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AU - Koyama, Tsukasa

AU - Kanba, Shigenobu

AU - Takeuchi, Masahiro

AU - Shimizu, Yuriko

AU - Arita, Eri

AU - Kuroishi, Kentaro

AU - Takeuchi, Masahiro

AU - Kamei, Shinya

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N2 - Rationale: Quetiapine fumarate is an atypical antipsychotic indicated for various mental disorders, but it has not been studied in Japanese patients with bipolar depression. Objectives: To evaluate the efficacy and safety of quetiapine XR (extended release) in Japanese patients with bipolar depression. Methods: In this multi-center, randomized, double-blind, placebo-controlled, fixed-dose study of 431 Japanese adults with bipolar I or II disorder, efficacy was determined by analyzing the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Secondary end points included MADRS response and remission rates, Hamilton Depression Scale 17-Item (HAM-D17), and Clinical Global Impressions-Bipolar (CGI-BP) scale scores. Safety was determined by monitoring adverse events and clinical assessments. Results: This study revealed a statistically significantly greater decrease in MADRS total score after 8 weeks of quetiapine XR 300 mg/day monotherapy compared with placebo (− 12.6 vs. − 10.1; p = 0.034). There were also improvements in MADRS response (44.1 vs. 35.6%) and remission (38.0 vs. 26.6%) rates as well as in HAM-D17 and CGI-BP scale scores compared with placebo. In the subgroup analysis of patients with bipolar I or II disorder, the adjusted mean changes in MADRS total score compared to placebo were − 2.3 and − 2.1, respectively. Adverse events occurred in 149 patients (83.2%) receiving quetiapine XR 300 mg/day and in 81 patients (45.8%) receiving placebo. The most common adverse events were somnolence and thirst, which is consistent with the previously reported safety profile. Conclusions: Once-daily monotherapy with quetiapine XR is an effective and well-tolerated treatment for bipolar depression in Japanese patients.

AB - Rationale: Quetiapine fumarate is an atypical antipsychotic indicated for various mental disorders, but it has not been studied in Japanese patients with bipolar depression. Objectives: To evaluate the efficacy and safety of quetiapine XR (extended release) in Japanese patients with bipolar depression. Methods: In this multi-center, randomized, double-blind, placebo-controlled, fixed-dose study of 431 Japanese adults with bipolar I or II disorder, efficacy was determined by analyzing the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Secondary end points included MADRS response and remission rates, Hamilton Depression Scale 17-Item (HAM-D17), and Clinical Global Impressions-Bipolar (CGI-BP) scale scores. Safety was determined by monitoring adverse events and clinical assessments. Results: This study revealed a statistically significantly greater decrease in MADRS total score after 8 weeks of quetiapine XR 300 mg/day monotherapy compared with placebo (− 12.6 vs. − 10.1; p = 0.034). There were also improvements in MADRS response (44.1 vs. 35.6%) and remission (38.0 vs. 26.6%) rates as well as in HAM-D17 and CGI-BP scale scores compared with placebo. In the subgroup analysis of patients with bipolar I or II disorder, the adjusted mean changes in MADRS total score compared to placebo were − 2.3 and − 2.1, respectively. Adverse events occurred in 149 patients (83.2%) receiving quetiapine XR 300 mg/day and in 81 patients (45.8%) receiving placebo. The most common adverse events were somnolence and thirst, which is consistent with the previously reported safety profile. Conclusions: Once-daily monotherapy with quetiapine XR is an effective and well-tolerated treatment for bipolar depression in Japanese patients.

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