UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013923 |
|---|---|
| Receipt number | R000016233 |
| Scientific Title | Randomized Clinical Trial to Verify a Cost-effectiveness of the Standard Pharmacotherapy for Major Depressive Disorder |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2017/05/12 12:53:30 |
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Basic information
Public title
Randomized Clinical Trial to Verify a Cost-effectiveness of the Standard Pharmacotherapy for Major Depressive Disorder
Acronym
Cost-effectiveness of the Pharmacotherapy for Major Depressive Disorder
Scientific Title
Randomized Clinical Trial to Verify a Cost-effectiveness of the Standard Pharmacotherapy for Major Depressive Disorder
Scientific Title:Acronym
Cost-effectiveness of the Pharmacotherapy for Major Depressive Disorder
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A verification of the cost-effectiveness of pharmacotherapy for major depressive disorder
Basic objectives2
Others
Basic objectives -Others
A verification of the cost-effectiveness of two kinds of pharmacotherapy for major depressive disorder
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
QIDS
QALY
cost
Key secondary outcomes
HAM-D
CGI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
escitalopram and aripiprazole
Interventions/Control_2
escitalopram and mirtazapine
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
major depressive disorder
Key exclusion criteria
Long QT, and so on
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Yamada |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
Psychiatry
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL
03-3810-1111
yamadaps@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Yamada |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
Psychiatry
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL
03-3810-1111
Homepage URL
http://www.twmu.ac.jp/DNH/department/psychiatry/
yamadaps@dnh.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Address
Tel
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
| 2014 | Year | 07 | Month | 01 | 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
| 2014 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 10 | Day |
Last modified on
| 2017 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016233
