Long-term mood/antidepressant effects of quetiapine extended-release formulation: an open-label, non-controlled extension study in Japanese patients with bipolar depression

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

Abstract

Background: In an 8-week, randomized, placebo-controlled, double-blind study, an extended-release formulation of quetiapine, quetiapine XR, demonstrated efficacy and safety in Japanese patients with bipolar depression. Bipolar disorder is a chronic disease requiring continuous treatment.

Methods: This was a long-term (52-week), open-label, non-controlled extension study to evaluate the long-term safety and efficacy of quetiapine XR in Japanese patients with bipolar depression who had previously completed the initial 8-week double-blind study. Efficacy was determined by the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Depression Scale 17-item (HAM-D17), and Clinical Global Impressions-Bipolar scale (CGI-BP). Safety evaluations included analysis of adverse events, clinical laboratory measures, vital signs, Drug-induced Extrapyramidal Symptoms Scale, Young Mania Rating Scale, and the Columbia Suicide Severity Rating Scale.

Results: The mean (SD) MADRS total score decreased from 30.9 (6.9) at baseline to 16.1 (10.6) at week 8, and eventually to 9.1 (8.7) at week 52. The sustained efficacy of quetiapine XR treatment was also shown using HAM-D17 total scores, CGI-BP-Severity and Change evaluations. The most common adverse events were somnolence, nasopharyngitis, and thirst. Long-term treatment with quetiapine XR caused no substantial changes in the safety profiles, including clinical laboratory parameters, and no new safety concerns were identified.

Conclusions: The efficacy of quetiapine XR was sustained long-term and no new safety concerns were identified in Japanese patients with bipolar depression.

Trial registration: ClinicalTrials.gov Registration: NCT01725308. Date of registration; 12th November 2012 (retrospectively registered).

Keywords: Bipolar disorder; Depression; Quetiapine XR.

Conflict of interest statement

Specific and substantive relationships are as follows: Shigenobu Kanba declares honoraria from MSD K.K., Astellas Pharma Inc., Mochida Pharmaceutical Co., Ltd., Eisai Co., Ltd., Takeda Pharmaceutical Co., Ltd., Dainippon-Sumitomo Pharma Co. Ltd., Otsuka Pharmaceutical Co., Ltd., Taisho-Toyama Pharmaceutical Co. Ltd., Janssen Pharmaceutical K.K., Meiji Seika Pharma Co. Ltd., Yoshitomiyakuhin Co., Nippon Chemiphar Co. Ltd., Daiichi Sankyo Co. Ltd., Pfizer Inc., Shionogi & Co., Ltd., and Mitsubishi Tanabe Pharma Co., and research funding from MSD K.K., Dainippon-Sumitomo Pharma Co. Ltd., Janssen Pharmaceutical K.K., Astellas Pharma Inc., Nippon Chemiphar Co. Ltd., Pfizer Inc., Mochida Pharmaceutical Co. Ltd., Eisai Co., Ltd. Meiji Seika Pharma Co., Ltd., Yoshitomiyakuhin Co., Shionogi & Co., Ltd., and Mitsubishi Tanabe Pharma Co. Mitsukuni Murasaki declares personal fees from Astellas Pharma Inc., Meiji Seika Pharma Co., Ltd., Eli Lilly Japan, Eisai Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Pfizer Inc., and Janssen Pharmaceutical K.K. Tsukasa Koyama declares personal fees from Astellas Pharma Inc., Eli Lilly Japan, Otsuka Pharmaceutical, and Mitsubishi Tanabe Pharma Co. Masahiro Takeuchi (takeuchim@pharm.kitasato-u.ac.jp) declares personal fees from Astellas Pharma Inc. Yuriko Shimizu, Eri Arita, Kentaro Kuroishi, Masahiro Takeuchi, and Shinya Kamei are employees of Astellas Pharma Inc.

Figures

Fig. 1
Fig. 1
Study design. Values in boxes represent the dose of quetiapine XR in mg. *Patients were allocated to the quetiapine XR 300 mg group, the quetiapine XR 150 mg group, or the placebo group during the double-blind phase. **The dose was increased from 150 mg/day to 300 mg/day in patients who met the guideline for dose increase in week 14 or week 16. ***Dose adjustment from 300 mg/day to 150 mg/day, or vice versa, was allowed in accordance with the guideline
Fig. 2
Fig. 2
Patient disposition. *The study drug was administered to 179 patients in the quetiapine XR 300 mg group, 74 patients in the quetiapine XR 150 mg group, and 177 patients in the placebo group
Fig. 3
Fig. 3
Time course of mean MADRS total score. Observed cases are shown. MADRS Montgomery–Åsberg Depression Rating Scale, LOCF Last Observation Carried Forward

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