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Long-term mood/antidepressant effects of quetiapine extended-release formulation: an open-label, non-controlled extension study in Japanese patients with bipolar depression.
BMC Psychiatry. 2019 06 26; 19(1):198.BP

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).

Authors+Show Affiliations

Department of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.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 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.; 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.Japan/Asia Clinical Development 2, Astellas Pharma Inc.; 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.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.; 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
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31242884

Citation

Kanba, Shigenobu, et al. "Long-term Mood/antidepressant Effects of Quetiapine Extended-release Formulation: an Open-label, Non-controlled Extension Study in Japanese Patients With Bipolar Depression." BMC Psychiatry, vol. 19, no. 1, 2019, p. 198.
Kanba S, Murasaki M, Koyama T, et al. Long-term mood/antidepressant effects of quetiapine extended-release formulation: an open-label, non-controlled extension study in Japanese patients with bipolar depression. BMC Psychiatry. 2019;19(1):198.
Kanba, S., Murasaki, M., Koyama, T., Takeuchi, M., Shimizu, Y., Arita, E., Kuroishi, K., Takeuchi, M., & Kamei, S. (2019). Long-term mood/antidepressant effects of quetiapine extended-release formulation: an open-label, non-controlled extension study in Japanese patients with bipolar depression. BMC Psychiatry, 19(1), 198. https://doi.org/10.1186/s12888-019-2181-9
Kanba S, et al. Long-term Mood/antidepressant Effects of Quetiapine Extended-release Formulation: an Open-label, Non-controlled Extension Study in Japanese Patients With Bipolar Depression. BMC Psychiatry. 2019 06 26;19(1):198. PubMed PMID: 31242884.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term mood/antidepressant effects of quetiapine extended-release formulation: an open-label, non-controlled extension study in Japanese patients with bipolar depression. AU - Kanba,Shigenobu, AU - Murasaki,Mitsukuni, AU - Koyama,Tsukasa, AU - Takeuchi,Masahiro, AU - Shimizu,Yuriko, AU - Arita,Eri, AU - Kuroishi,Kentaro, AU - Takeuchi,Masahiro, AU - Kamei,Shinya, Y1 - 2019/06/26/ PY - 2018/07/31/received PY - 2019/06/13/accepted PY - 2019/6/28/entrez PY - 2019/6/28/pubmed PY - 2020/3/31/medline KW - Bipolar disorder KW - Depression KW - Quetiapine XR SP - 198 EP - 198 JF - BMC psychiatry JO - BMC Psychiatry VL - 19 IS - 1 N2 - 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). SN - 1471-244X UR - https://www.unboundmedicine.com/medline/citation/31242884/Long_term_mood/antidepressant_effects_of_quetiapine_extended_release_formulation:_an_open_label_non_controlled_extension_study_in_Japanese_patients_with_bipolar_depression_ L2 - https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-019-2181-9 DB - PRIME DP - Unbound Medicine ER -