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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with depression in bipolar disorder | Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | Drug | Oral (extended-release tablet) |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with depressive symptoms of bipolar disorder who have not been treated with quetiapine fumarate
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00023 | Aichi | Japan | ||||
| Site JP00005 |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| 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 |
| 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 |
| Site JP00034 | Hiroshima | Japan |
| Site JP00001 | Hokkaido | Japan |
| Site JP00028 | Hyōgo | Japan |
| Site JP00008 | Ibaraki | Japan |
| Site JP00017 | Ishikawa | Japan |
| Site JP00037 | Kagawa | Japan |
| Site JP00046 | Kagoshima | Japan |
| Site JP00014 | Kanagawa | Japan |
| Site JP00039 | Kochi | Japan |
| Site JP00043 | Kumamoto | Japan |
| Site JP00026 | Kyoto | Japan |
| Site JP00024 | Mie | Japan |
| Site JP00004 | Miyagi | Japan |
| Site JP00045 | Miyazaki | Japan |
| Site JP00020 | Nagano | Japan |
| Site JP00042 | Nagasaki | Japan |
| Site JP00029 | Nara | Japan |
| Site JP00015 | Niigata | Japan |
| Site JP00003 | Numakunai | Japan |
| Site JP00033 | Okayama | Japan |
| Site JP00047 | Okinawa | Japan |
| Site JP00027 | Osaka | Japan |
| Site JP00044 | Ōita | Japan |
| Site JP00041 | Saga | Japan |
| Site JP00011 | Saitama | Japan |
| Site JP00025 | Shiga | Japan |
| Site JP00032 | Shimane | Japan |
| Site JP00022 | Shizuoka | Japan |
| Site JP00009 | Tochigi | Japan |
| Site JP00036 | Tokushima | Japan |
| Site JP00013 | Tokyo | Japan |
| Site JP00031 | Tottori | Japan |
| Site JP00016 | Toyama | Japan |
| Site JP00030 | Wakayama | Japan |
| Site JP00006 | Yamagata | Japan |
| Site JP00035 | Yamaguchi | Japan |
| Site JP00019 | Yamanashi | Japan |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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