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

NCT ID: NCT03403790

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-15

Study Completion Date

2020-03-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with depression in bipolar disorder

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

Quetiapine

Intervention Type DRUG

Oral (extended-release tablet)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quetiapine

Oral (extended-release tablet)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bipresso

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site JP00023

Aichi, , Japan

Site Status

Site JP00005

Akita, , Japan

Site Status

Site JP00002

Aomori, , Japan

Site Status

Site JP00012

Chiba, , Japan

Site Status

Site JP00038

Ehime, , Japan

Site Status

Site JP00018

Fukui, , Japan

Site Status

Site JP00040

Fukuoka, , Japan

Site Status

Site JP00007

Fukushima, , Japan

Site Status

Site JP00021

Gifu, , Japan

Site Status

Site JP00010

Gunma, , Japan

Site Status

Site JP00034

Hiroshima, , Japan

Site Status

Site JP00001

Hokkaido, , Japan

Site Status

Site JP00028

Hyōgo, , Japan

Site Status

Site JP00008

Ibaraki, , Japan

Site Status

Site JP00017

Ishikawa, , Japan

Site Status

Site JP00037

Kagawa, , Japan

Site Status

Site JP00046

Kagoshima, , Japan

Site Status

Site JP00014

Kanagawa, , Japan

Site Status

Site JP00039

Kochi, , Japan

Site Status

Site JP00043

Kumamoto, , Japan

Site Status

Site JP00026

Kyoto, , Japan

Site Status

Site JP00024

Mie, , Japan

Site Status

Site JP00004

Miyagi, , Japan

Site Status

Site JP00045

Miyazaki, , Japan

Site Status

Site JP00020

Nagano, , Japan

Site Status

Site JP00042

Nagasaki, , Japan

Site Status

Site JP00029

Nara, , Japan

Site Status

Site JP00015

Niigata, , Japan

Site Status

Site JP00003

Numakunai, , Japan

Site Status

Site JP00033

Okayama, , Japan

Site Status

Site JP00047

Okinawa, , Japan

Site Status

Site JP00027

Osaka, , Japan

Site Status

Site JP00044

Ōita, , Japan

Site Status

Site JP00041

Saga, , Japan

Site Status

Site JP00011

Saitama, , Japan

Site Status

Site JP00025

Shiga, , Japan

Site Status

Site JP00032

Shimane, , Japan

Site Status

Site JP00022

Shizuoka, , Japan

Site Status

Site JP00009

Tochigi, , Japan

Site Status

Site JP00036

Tokushima, , Japan

Site Status

Site JP00013

Tokyo, , Japan

Site Status

Site JP00031

Tottori, , Japan

Site Status

Site JP00016

Toyama, , Japan

Site Status

Site JP00030

Wakayama, , Japan

Site Status

Site JP00006

Yamagata, , Japan

Site Status

Site JP00035

Yamaguchi, , Japan

Site Status

Site JP00019

Yamanashi, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6949-MA-3199

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.