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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.

Detailed Description
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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.

Official Title
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Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder

Conditions
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Depression, Bipolar Disorder

Intervention / Treatment
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* Drug: Quetiapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with depression in bipolar disorder<br>Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time | Drug: Quetiapine<br>* Oral (extended-release tablet)<br>* Other names: Bipresso;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by incidence of serious adverse events | To assess incidence of serious adverse events as a criteria of safety variables. | 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. | 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. | Up to Week 12 | 
| Safety assessed by vital signs: Blood pressure (sitting) | To assess blood pressure as a criteria of safety variables | Up to Week 12 | 
| Safety assessed by vital signs: Pulse rate (sitting) | To assess pulse rate as a criteria of safety variables | Up to Week 12 | 
| Safety assessed by 12-lead electrocardiogram | To assess 12-lead electrocardiogram as a criteria of safety variables | Up to Week 12 | 
| Safety assessed by body weight | To assess body weight as a criteria of safety variables | Up to Week 12 | 
| Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) | To assess MADRS as a criteria of efficacy variables | 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 | 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 | Up to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipresso, Drug use-results survey, Quetiapine