Clinical trial NCT03403790: A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
Official title: Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Bipolar Disorder
Keywords: Bipresso
Drug use-results survey
Quetiapine
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2018-01-19
Enrollment: 369
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with depressive symptoms of bipolar disorder who have not been treated with quetiapine fumarate

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety assessed by incidence of serious adverse events
timeFrame: Up to Week 12
measure: Safety assessed by incidence of adverse drug reactions
timeFrame: Up to Week 12
measure: Safety assessed by laboratory values and changes from baseline over time
timeFrame: Up to Week 12
measure: Safety assessed by vital signs: Blood pressure (sitting)
timeFrame: Up to Week 12
measure: Safety assessed by vital signs: Pulse rate (sitting)
timeFrame: Up to Week 12
measure: Safety assessed by 12-lead electrocardiogram
timeFrame: Up to Week 12
measure: Safety assessed by body weight
timeFrame: Up to Week 12
measure: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline and up to Week 12
measure: Change from baseline in Clinical Global Impression-Bipolar-Severity of illness (CGI-BP-S)
timeFrame: Baseline and up to Week 12
measure: Efficacy assessed by Clinical Global Impression-Bipolar-Change (CGI-BP-C)
timeFrame: Up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site JP00023
city: Akita
country: Japan
facility: Site JP00005
city: Aomori
country: Japan
facility: Site JP00002
city: Chiba
country: Japan
facility: Site JP00012
city: Ehime
country: Japan
facility: Site JP00038
city: Fukui
country: Japan
facility: Site JP00018
city: Fukuoka
country: Japan
facility: Site JP00040
city: Fukushima
country: Japan
facility: Site JP00007
city: Gifu
country: Japan
facility: Site JP00021
city: Gunma
country: Japan
facility: Site JP00010
city: Hiroshima
country: Japan
facility: Site JP00034
city: Hokkaido
country: Japan
facility: Site JP00001
city: Hyogo
country: Japan
facility: Site JP00028
city: Ibaraki
country: Japan
facility: Site JP00008
city: Ishikawa
country: Japan
facility: Site JP00017
city: Iwate
country: Japan
facility: Site JP00003
city: Kagawa
country: Japan
facility: Site JP00037
city: Kagoshima
country: Japan
facility: Site JP00046
city: Kanagawa
country: Japan
facility: Site JP00014
city: Kochi
country: Japan
facility: Site JP00039
city: Kumamoto
country: Japan
facility: Site JP00043
city: Kyoto
country: Japan
facility: Site JP00026
city: Mie
country: Japan
facility: Site JP00024
city: Miyagi
country: Japan
facility: Site JP00004
city: Miyazaki
country: Japan
facility: Site JP00045
city: Nagano
country: Japan
facility: Site JP00020
city: Nagasaki
country: Japan
facility: Site JP00042
city: Nara
country: Japan
facility: Site JP00029
city: Niigata
country: Japan
facility: Site JP00015
city: Oita
country: Japan
facility: Site JP00044
city: Okayama
country: Japan
facility: Site JP00033
city: Okinawa
country: Japan
facility: Site JP00047
city: Osaka
country: Japan
facility: Site JP00027
city: Saga
country: Japan
facility: Site JP00041
city: Saitama
country: Japan
facility: Site JP00011
city: Shiga
country: Japan
facility: Site JP00025
city: Shimane
country: Japan
facility: Site JP00032
city: Shizuoka
country: Japan
facility: Site JP00022
city: Tochigi
country: Japan
facility: Site JP00009
city: Tokushima
country: Japan
facility: Site JP00036
city: Tokyo
country: Japan
facility: Site JP00013
city: Tottori
country: Japan
facility: Site JP00031
city: Toyama
country: Japan
facility: Site JP00016
city: Wakayama
country: Japan
facility: Site JP00030
city: Yamagata
country: Japan
facility: Site JP00006
city: Yamaguchi
country: Japan
facility: Site JP00035
city: Yamanashi
country: Japan
facility: Site JP00019
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_DIRECTOR
References: