A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
1 other identifier
observational
369
1 country
47
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Typical duration for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2018
CompletedStudy Start
First participant enrolled
January 15, 2018
CompletedFirst Posted
Study publicly available on registry
January 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2020
CompletedOctober 16, 2024
April 1, 2020
2.2 years
January 7, 2018
October 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
Study Arms (1)
Patients with depression in bipolar disorder
Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time
Interventions
Oral (extended-release tablet)
Eligibility Criteria
Patients with depressive symptoms of bipolar disorder who have not been treated with quetiapine fumarate
You may qualify if:
- 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)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2018
First Posted
January 19, 2018
Study Start
January 15, 2018
Primary Completion
March 19, 2020
Study Completion
March 19, 2020
Last Updated
October 16, 2024
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share
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/.