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

Depression Clinical Trial

Official title:

Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403790
• Other study ID #: 6949-MA-3199
• Status: Completed
• Start date: January 15, 2018
• Est. completion date: March 19, 2020

Study information

• Verified date: April 2020
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Quetiapine
Oral (extended-release tablet)

Locations

Country	Name	City	State
Japan	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	Hyogo
Japan	Site JP00008	Ibaraki
Japan	Site JP00017	Ishikawa
Japan	Site JP00003	Iwate
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 JP00044	Oita
Japan	Site JP00033	Okayama
Japan	Site JP00047	Okinawa
Japan	Site JP00027	Osaka
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

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Safety assessed by vital signs: Blood pressure (sitting)	To assess blood pressure as a criteria of safety variables	Up to Week 12
Primary	Safety assessed by vital signs: Pulse rate (sitting)	To assess pulse rate as a criteria of safety variables	Up to Week 12
Primary	Safety assessed by 12-lead electrocardiogram	To assess 12-lead electrocardiogram as a criteria of safety variables	Up to Week 12
Primary	Safety assessed by body weight	To assess body weight as a criteria of safety variables	Up to Week 12
Primary	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
Primary	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
Primary	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