An observational study in Depression and Bipolar Disorder, sponsored by Astellas Pharma Inc. Completed at 47 sites in Japan. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Astellas Pharma Inc · Observational
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.
Patients with depressive symptoms of bipolar disorder who have not been treated with quetiapine fumarate
Exclusion Criteria:
Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time
Drug: Quetiapine
Oral (extended-release tablet)
Also known as: Bipresso
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
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
Plan to share: No — 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/.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc