UMIN-CTR Clinical Trial

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for 365 days from the Index date. 2)Aged 18 years and older at the time of the index date 3)Patients who have not withdrawn insurance for 365 days from the Index date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