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

Completed

• Conditions: Bipolar Disorder; Depression
• Interventions: Drug: Quetiapine

• Registration Number: NCT03403790
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study First Submitted: 2018-01-07
• Study Start: 2018-01-15
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-19
• Primary Completion: 2020-03-19
• Study Completion: 2020-03-19
• Status Verified: 2020-04
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with depression in bipolar disorder	Quetiapine	Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time

Primary Outcome Measures

Name	Time	Method
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 12-lead electrocardiogram	Up to Week 12	To assess 12-lead electrocardiogram as a criteria of safety 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
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 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

Trial Locations

Locations (47)

Site JP00023; 🇯🇵 Aichi, Japan

Site JP00005; 🇯🇵 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

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