Bipolar Disorder, Depression
Conditions
Keywords
Bipresso, Drug use-results survey, Quetiapine
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.
Interventions
DRUGQuetiapine
Oral (extended-release tablet)
Sponsors
Astellas Pharma Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 12-lead electrocardiogram | Up to Week 12 | To assess 12-lead electrocardiogram 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 |
| 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 |
Countries
Japan
Outcome results
None listed