A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder

Primary outcomes

1. Safety assessed by incidence of serious adverse events

   Time frame: Up to Week 12

   To assess incidence of serious adverse events as a criteria of safety variables.

2. Safety assessed by incidence of adverse drug reactions

   Time frame: Up to Week 12

   To assess incidence of adverse drug reactions as a criteria of safety variables.

3. Safety assessed by laboratory values and changes from baseline over time

   Time frame: 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.

4. Safety assessed by vital signs: Blood pressure (sitting)

   Time frame: Up to Week 12

   To assess blood pressure as a criteria of safety variables

5. Safety assessed by vital signs: Pulse rate (sitting)

   Time frame: Up to Week 12

   To assess pulse rate as a criteria of safety variables

6. Safety assessed by 12-lead electrocardiogram

   Time frame: Up to Week 12

   To assess 12-lead electrocardiogram as a criteria of safety variables

7. Safety assessed by body weight

   Time frame: Up to Week 12

   To assess body weight as a criteria of safety variables

8. Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

   Time frame: Baseline and up to Week 12

   To assess MADRS as a criteria of efficacy variables

9. Change from baseline in Clinical Global Impression-Bipolar-Severity of illness (CGI-BP-S)

   Time frame: Baseline and up to Week 12

   To assess CGI-BP-S as a criteria of efficacy variables

10. Efficacy assessed by Clinical Global Impression-Bipolar-Change (CGI-BP-C)

    Time frame: Up to Week 12

    To assess CGI-BP-C as a criteria of efficacy variables