UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054174 |
|---|---|
| Receipt number | R000061302 |
| Scientific Title | Real-world effectiveness of hypertensive drugs in the treatment of bipolar disorder: A nationwide within-individual study |
| Date of disclosure of the study information | 2024/04/17 |
| Last modified on | 2024/04/17 10:51:07 |
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Basic information
Public title
Effectiveness of hypertensive drugs for the treatment of bipolar disorder
Acronym
HYP-BD
Scientific Title
Real-world effectiveness of hypertensive drugs in the treatment of bipolar disorder: A nationwide within-individual study
Scientific Title:Acronym
HYP-BD
Region
| Japan |
Condition
Condition
Bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the hazard of psychiatric admission during the period of specifi c hypertensive drug use to the non-use period of that drupatients diagnosed with bipolar disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to psychiatric hospitalization: The follow-up will start at the next day of the index date for outpatients and the next day of the discharge date fotime will be reset when an outcome event occurs and re-start follow-up at the next day of the discharge date. The follow-up will end at death or on May 31/2023.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Defi nitive primary diagnosis of bipolar disorder during outpatient psychiatric visits or psychiatric hospitalization during 1 April 2013 and 31 March date will be considered the index date.
2) At least two prescriptions of lithium, each with a dosage of >=200 mg per day in the study period.
3) Aged 20 years or older at the index date.
4) Enroll in the database at least 365 days prior to the index date.
5) No history of a diagnosis of dementia prior to the index date.
Key exclusion criteria
Not applicable.
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | Tadafumi |
| Middle name | |
| Last name | Kato |
Organization
Juntendo University
Division name
Department of Psychiatry and Behavioral Science, Juntendo University Graduate School of Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-5802-1070
tadafumi.kato@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tadafumi |
| Middle name | |
| Last name | Kato |
Organization
Juntendo University
Division name
Department of Psychiatry and Behavioral Science, Juntendo University Graduate School of Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3813-3111
Homepage URL
tadafumi.kato@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Tadafumi Kato
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
+81-3-3813-3111
hongo-rinri@juntendo.ac.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
| 2024 | Year | 04 | Month | 17 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing to note
Management information
Registered date
| 2024 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061302
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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