A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
- Registration Number
- NCT03403790
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.
- Detailed Description
This is a post-marketing use-result survey study required for products in Japan. The investigator will register the patient who have been taking this product for the first time within 14 days after the start of treatment (inclusive of the start day). For each of the registered patients (including withdrawals and dropouts), the investigator will enter the survey data on the case report form.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 369
- Patients with depressive symptoms of bipolar disorder
- Patients who have previously not been treated with quetiapine fumarate (immediate-release formulations of quetiapine fumarate and Bipresso Extended-Release Tablets)
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with depression in bipolar disorder Quetiapine Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time
- Primary Outcome Measures
Name Time Method Safety assessed by vital signs: Blood pressure (sitting) Up to Week 12 To assess blood pressure as a criteria of safety variables
Safety assessed by vital signs: Pulse rate (sitting) Up to Week 12 To assess pulse rate as a criteria of safety variables
Safety assessed by body weight Up to Week 12 To assess body weight as a criteria of safety variables
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Baseline and up to Week 12 To assess MADRS as a criteria of efficacy variables
Safety assessed by incidence of serious adverse events Up to Week 12 To assess incidence of serious adverse events as a criteria of safety variables.
Safety assessed by incidence of adverse drug reactions Up to Week 12 To assess incidence of adverse drug reactions as a criteria of safety variables.
Safety assessed by laboratory values and changes from baseline over time Up to Week 12 To assess profile of laboratory value transition and potential clinical significance as a criteria of safety variables. The investigators will assess the severity and clinical relevance, and will report as an adverse event as necessary.
Safety assessed by 12-lead electrocardiogram Up to Week 12 To assess 12-lead electrocardiogram as a criteria of safety variables
Change from baseline in Clinical Global Impression-Bipolar-Severity of illness (CGI-BP-S) Baseline and up to Week 12 To assess CGI-BP-S as a criteria of efficacy variables
Efficacy assessed by Clinical Global Impression-Bipolar-Change (CGI-BP-C) Up to Week 12 To assess CGI-BP-C as a criteria of efficacy variables
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Site JP00005
🇯🇵Akita, Japan
Site JP00038
🇯🇵Ehime, Japan
Site JP00007
🇯🇵Fukushima, Japan
Site JP00001
🇯🇵Hokkaido, Japan
Site JP00017
🇯🇵Ishikawa, Japan
Site JP00003
🇯🇵Iwate, Japan
Site JP00046
🇯🇵Kagoshima, Japan
Site JP00043
🇯🇵Kumamoto, Japan
Site JP00026
🇯🇵Kyoto, Japan
Site JP00024
🇯🇵Mie, Japan
Site JP00004
🇯🇵Miyagi, Japan
Site JP00020
🇯🇵Nagano, Japan
Site JP00044
🇯🇵Oita, Japan
Site JP00025
🇯🇵Shiga, Japan
Site JP00031
🇯🇵Tottori, Japan
Site JP00042
🇯🇵Nagasaki, Japan
Site JP00029
🇯🇵Nara, Japan
Site JP00015
🇯🇵Niigata, Japan
Site JP00047
🇯🇵Okinawa, Japan
Site JP00035
🇯🇵Yamaguchi, Japan
Site JP00041
🇯🇵Saga, Japan
Site JP00016
🇯🇵Toyama, Japan
Site JP00018
🇯🇵Fukui, Japan
Site JP00040
🇯🇵Fukuoka, Japan
Site JP00028
🇯🇵Hyogo, Japan
Site JP00002
🇯🇵Aomori, Japan
Site JP00010
🇯🇵Gunma, Japan
Site JP00021
🇯🇵Gifu, Japan
Site JP00034
🇯🇵Hiroshima, Japan
Site JP00008
🇯🇵Ibaraki, Japan
Site JP00037
🇯🇵Kagawa, Japan
Site JP00014
🇯🇵Kanagawa, Japan
Site JP00012
🇯🇵Chiba, Japan
Site JP00039
🇯🇵Kochi, Japan
Site JP00045
🇯🇵Miyazaki, Japan
Site JP00033
🇯🇵Okayama, Japan
Site JP00011
🇯🇵Saitama, Japan
Site JP00036
🇯🇵Tokushima, Japan
Site JP00013
🇯🇵Tokyo, Japan
Site JP00032
🇯🇵Shimane, Japan
Site JP00027
🇯🇵Osaka, Japan
Site JP00022
🇯🇵Shizuoka, Japan
Site JP00009
🇯🇵Tochigi, Japan
Site JP00030
🇯🇵Wakayama, Japan
Site JP00006
🇯🇵Yamagata, Japan
Site JP00019
🇯🇵Yamanashi, Japan
Site JP00023
🇯🇵Aichi, Japan