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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041304
Receipt No. R000047148
Scientific Title Observational Study on treatment status and adherence in patients with Bipolar disorder Using claims database in Japan.
Date of disclosure of the study information 2020/08/10
Last modified on 2020/08/04

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Basic information
Public title Observational Study on treatment status and adherence in patients with Bipolar disorder Using claims database in Japan.
Acronym Observational Study on treatment status and adherence in patients with Bipolar disorder Using claims database in Japan.
Scientific Title Observational Study on treatment status and adherence in patients with Bipolar disorder Using claims database in Japan.
Scientific Title:Acronym Observational Study on treatment status and adherence in patients with Bipolar disorder Using claims database in Japan.
Region
Japan

Condition
Condition Bipolar disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the prescription status in patients with bipolar disorder.
To explore factors affecting medication adherence.
Basic objectives2 Others
Basic objectives -Others prescription status
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Proportion of Days Covered (PDC)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Meeting all of the following criteria
1)Patients who started treatment for bipolar disorder for 365 days from the Index date.
2)Aged 18 years and older at the time of the index date
3)Patients who have not withdrawn insurance for 365 days from the Index date
Key exclusion criteria Patients who meet the following
1)Patients who started treatment for Schizophrenia, dementia, autism and ADHD during the enrollment period.
2)Patients who started treatment for bipolar disorder or started treatment with target drug for bipolar disorder for 365 days from the Index date.
Target sample size 14000

Research contact person
Name of lead principal investigator
1st name Kazushi
Middle name
Last name Sakurai
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Medical Affairs Department
Zip code 108-8242
Address 2-16-4 konan,Minato-ku,Tokyo
TEL 03-6717-1400
Email sakuraik@otsuka.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Sano
Organization Otsuka Pharmaceutical Co., Ltd.
Division name Medical Affairs Department
Zip code 5400021
Address 3-2-27 Ote-dori,Chuo-ku,Osaka 540-0021
TEL 06-6943-7722
Homepage URL
Email sanoh@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The research ethics committee of Otsuka Pharmaceutical Co., Ltd.
Address 463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel 088-665-2126
Email Imaizumi.Takashi@otsuka.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 13788
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2020 Year 01 Month 24 Day
Date of IRB
2020 Year 01 Month 24 Day
Anticipated trial start date
2020 Year 04 Month 10 Day
Last follow-up date
2020 Year 06 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We examine the "influence rate (PDC) in the treatment period (1 year) for bipolar disorder" and the influencing factors.

Management information
Registered date
2020 Year 08 Month 04 Day
Last modified on
2020 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047148

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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