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

October 15, 2024 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Site JP00023
      • Akita, Japan
        • Site JP00005
      • Aomori, Japan
        • Site JP00002
      • Chiba, Japan
        • Site JP00012
      • Ehime, Japan
        • Site JP00038
      • Fukui, Japan
        • Site JP00018
      • Fukuoka, Japan
        • Site JP00040
      • Fukushima, Japan
        • Site JP00007
      • Gifu, Japan
        • Site JP00021
      • Gunma, Japan
        • Site JP00010
      • Hiroshima, Japan
        • Site JP00034
      • Hokkaido, Japan
        • Site JP00001
      • Hyogo, Japan
        • Site JP00028
      • Ibaraki, Japan
        • Site JP00008
      • Ishikawa, Japan
        • Site JP00017
      • Iwate, Japan
        • Site JP00003
      • Kagawa, Japan
        • Site JP00037
      • Kagoshima, Japan
        • Site JP00046
      • Kanagawa, Japan
        • Site JP00014
      • Kochi, Japan
        • Site JP00039
      • Kumamoto, Japan
        • Site JP00043
      • Kyoto, Japan
        • Site JP00026
      • Mie, Japan
        • Site JP00024
      • Miyagi, Japan
        • Site JP00004
      • Miyazaki, Japan
        • Site JP00045
      • Nagano, Japan
        • Site JP00020
      • Nagasaki, Japan
        • Site JP00042
      • Nara, Japan
        • Site JP00029
      • Niigata, Japan
        • Site JP00015
      • Oita, Japan
        • Site JP00044
      • Okayama, Japan
        • Site JP00033
      • Okinawa, Japan
        • Site JP00047
      • Osaka, Japan
        • Site JP00027
      • Saga, Japan
        • Site JP00041
      • Saitama, Japan
        • Site JP00011
      • Shiga, Japan
        • Site JP00025
      • Shimane, Japan
        • Site JP00032
      • Shizuoka, Japan
        • Site JP00022
      • Tochigi, Japan
        • Site JP00009
      • Tokushima, Japan
        • Site JP00036
      • Tokyo, Japan
        • Site JP00013
      • Tottori, Japan
        • Site JP00031
      • Toyama, Japan
        • Site JP00016
      • Wakayama, Japan
        • Site JP00030
      • Yamagata, Japan
        • Site JP00006
      • Yamaguchi, Japan
        • Site JP00035
      • Yamanashi, Japan
        • Site JP00019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with depressive symptoms of bipolar disorder who have not been treated with quetiapine fumarate

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with depression in bipolar disorder
Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time
Drug: Quetiapine
Oral (extended-release tablet)
Other Names:
  • Bipresso

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessed by incidence of serious adverse events
Time Frame: Up to Week 12
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
Time Frame: Up to Week 12
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
Time Frame: 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.
Up to Week 12
Safety assessed by vital signs: Blood pressure (sitting)
Time Frame: Up to Week 12
To assess blood pressure as a criteria of safety variables
Up to Week 12
Safety assessed by vital signs: Pulse rate (sitting)
Time Frame: Up to Week 12
To assess pulse rate as a criteria of safety variables
Up to Week 12
Safety assessed by 12-lead electrocardiogram
Time Frame: Up to Week 12
To assess 12-lead electrocardiogram as a criteria of safety variables
Up to Week 12
Safety assessed by body weight
Time Frame: Up to Week 12
To assess body weight as a criteria of safety variables
Up to Week 12
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline and up to Week 12
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)
Time Frame: Baseline and up to Week 12
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)
Time Frame: Up to Week 12
To assess CGI-BP-C as a criteria of efficacy variables
Up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Central Contact, Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

March 19, 2020

Study Completion (Actual)

March 19, 2020

Study Registration Dates

First Submitted

January 7, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6949-MA-3199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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