UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056181 |
|---|---|
| Receipt number | R000063914 |
| Scientific Title | Real-world antidepressant prescription for patients with major depressive disorder in Japan: a Retrospective Cohort Study Using a Japanese Claim Database |
| Date of disclosure of the study information | 2024/11/18 |
| Last modified on | 2025/05/20 09:32:20 |
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Basic information
Public title
Real-world antidepressant prescription for patients with major depressive disorder in Japan: a Retrospective Cohort Study Using a Japanese Claim Database
Acronym
Real-world antidepressant prescription for patients with major depressive disorder in Japan: a Retrospective Cohort Study Using a Japanese Claim Database
Scientific Title
Real-world antidepressant prescription for patients with major depressive disorder in Japan: a Retrospective Cohort Study Using a Japanese Claim Database
Scientific Title:Acronym
Real-world antidepressant prescription for patients with major depressive disorder in Japan: a Retrospective Cohort Study Using a Japanese Claim Database
Region
| Japan |
Condition
Condition
Major depressive disorder (MDD)
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to describe the relationship between prescription patterns and patient characteristics of antidepressants in Japan after the launch of vortioxetine.
Basic objectives2
Others
Basic objectives -Others
Data-base study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The distribution of first-line antidepressant prescriptions among patients newly prescribed antidepressants after the launch of vortioxetine and patient characteristics that may influnce the choice of first-line antidepressant (gender, age, concomitant medications, comorbidities, etc.).
Key secondary outcomes
The treatment modification patterns (discontinuation, continuation, treatment change) within the first three months following the prescription of the first-line antidepressant and patient characteristics that may influence these patterns (gender, age, concomitant medications, comorbidities, etc.).
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
1. Have a diagnosis code of MDD (ICD10= F32, 33) after November 2019.
2. Newly prescribed antidepressants after November 2019.
3. Age 18 years and older.
Key exclusion criteria
1. No diagnostic code for MDD on index date.
2. Have schizophrenia diagnosis code on index date and look-back period
3. Antidepressants are prescribed during the look-back period.
4. Insufficient follow-up period (90 days after index date) .
5. Insufficient Look-back period (180 days back from index date).
Target sample size
179181
Research contact person
Name of lead principal investigator
| 1st name | Miwa |
| Middle name | |
| Last name | Izutsu |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3242-1256
miwa.izutsu@takeda.com
Public contact
Name of contact person
| 1st name | Fumie |
| Middle name | |
| Last name | Tokuda |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo, 103-8668, Japan
TEL
03-3242-1256
Homepage URL
fumie.tokuda@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
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
Not applicable
Address
Same as above
Tel
Same as above
Same as above
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 | 11 | Month | 18 | 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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 04 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Because this is a database study, it has not been reviewed by an ethics review committee. For convenience, the date of in-house approval is given.
Management information
Registered date
| 2024 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063914
