UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041304 |
|---|---|
| Receipt number | 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 12:46:20 |
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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3)Patients who have not withdrawn insurance for 365 days from the Index date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
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
sanoh@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
