The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.
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.
Study Type
OBSERVATIONAL
Enrollment
369
Oral (extended-release tablet)
Safety assessed by incidence of serious adverse events
To assess incidence of serious adverse events as a criteria of safety variables.
Time frame: Up to Week 12
Safety assessed by incidence of adverse drug reactions
To assess incidence of adverse drug reactions as a criteria of safety variables.
Time frame: Up to Week 12
Safety assessed by laboratory values and changes from baseline over time
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.
Time frame: Up to Week 12
Safety assessed by vital signs: Blood pressure (sitting)
To assess blood pressure as a criteria of safety variables
Time frame: Up to Week 12
Safety assessed by vital signs: Pulse rate (sitting)
To assess pulse rate as a criteria of safety variables
Time frame: Up to Week 12
Safety assessed by 12-lead electrocardiogram
To assess 12-lead electrocardiogram as a criteria of safety variables
Time frame: Up to Week 12
Safety assessed by body weight
To assess body weight as a criteria of safety variables
Time frame: Up to Week 12
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
To assess MADRS as a criteria of efficacy variables
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Site JP00023
Aichi, Japan
Site JP00005
Akita, Japan
Site JP00002
Aomori, Japan
Site JP00012
Chiba, Japan
Site JP00038
Ehime, Japan
Site JP00018
Fukui, Japan
Site JP00040
Fukuoka, Japan
Site JP00007
Fukushima, Japan
Site JP00021
Gifu, Japan
Site JP00010
Gunma, Japan
...and 37 more locations
Time frame: Baseline and up to Week 12
Change from baseline in Clinical Global Impression-Bipolar-Severity of illness (CGI-BP-S)
To assess CGI-BP-S as a criteria of efficacy variables
Time frame: Baseline and up to Week 12
Efficacy assessed by Clinical Global Impression-Bipolar-Change (CGI-BP-C)
To assess CGI-BP-C as a criteria of efficacy variables
Time frame: Up to Week 12