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Multi-center, randomized, double-blind, placebo-controlled study of quetiapine extended-release formulation in Japanese patients with bipolar depression.
Psychopharmacology (Berl). 2018 Oct; 235(10):2859-2869.P

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.

Authors+Show Affiliations

Institute of CNS Pharmacology, 3-14-20 Sagamiohno, Minami-ku, Sagamihara, Kanagawa, 252-0303, Japan.Ohyachi Hospital, Clinical Research Center, 5-7-10 Ohyachi-higashi, Atsubetsu-ku, Sapporo, Hokkaido, 004-0041, Japan.Department of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.Department of Clinical Medicine, School of Pharmacy, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan.Japan/Asia Clinical Development 2, Astellas Pharma Inc., Astellas Pharma Inc.; 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.Global Clinical Science, Astellas Pharma Europe B.V, Sylviusweg 62, PO Box 344, 2300 AH, Leiden, The Netherlands.Japan-Asia Data Science, Astellas Pharma Inc., 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.Japan/Asia Clinical Development 2, Astellas Pharma Inc., Astellas Pharma Inc.; 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan. shinya.kamei@astellas.com.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

30069587

Citation

Murasaki, Mitsukuni, et al. "Multi-center, Randomized, Double-blind, Placebo-controlled Study of Quetiapine Extended-release Formulation in Japanese Patients With Bipolar Depression." Psychopharmacology, vol. 235, no. 10, 2018, pp. 2859-2869.
Murasaki M, Koyama T, Kanba S, et al. Multi-center, randomized, double-blind, placebo-controlled study of quetiapine extended-release formulation in Japanese patients with bipolar depression. Psychopharmacology (Berl). 2018;235(10):2859-2869.
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, 235(10), 2859-2869. https://doi.org/10.1007/s00213-018-4977-6
Murasaki M, et al. Multi-center, Randomized, Double-blind, Placebo-controlled Study of Quetiapine Extended-release Formulation in Japanese Patients With Bipolar Depression. Psychopharmacology (Berl). 2018;235(10):2859-2869. PubMed PMID: 30069587.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multi-center, randomized, double-blind, placebo-controlled study of quetiapine extended-release formulation in Japanese patients with bipolar depression. AU - Murasaki,Mitsukuni, AU - Koyama,Tsukasa, AU - Kanba,Shigenobu, AU - Takeuchi,Masahiro, AU - Shimizu,Yuriko, AU - Arita,Eri, AU - Kuroishi,Kentaro, AU - Takeuchi,Masahiro, AU - Kamei,Shinya, Y1 - 2018/08/01/ PY - 2018/01/31/received PY - 2018/07/17/accepted PY - 2018/8/3/pubmed PY - 2019/1/1/medline PY - 2018/8/3/entrez KW - Atypical antipsychotics KW - Bipolar disorder KW - Depression KW - MADRS KW - Quetiapine XR SP - 2859 EP - 2869 JF - Psychopharmacology JO - Psychopharmacology (Berl.) VL - 235 IS - 10 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. SN - 1432-2072 UR - https://www.unboundmedicine.com/medline/citation/30069587/Multi_center_randomized_double_blind_placebo_controlled_study_of_quetiapine_extended_release_formulation_in_Japanese_patients_with_bipolar_depression_ L2 - https://dx.doi.org/10.1007/s00213-018-4977-6 DB - PRIME DP - Unbound Medicine ER -