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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017278
Receipt No. R000020052
Scientific Title The effect of duloxetine in depression of menopose women
Date of disclosure of the study information 2015/04/25
Last modified on 2015/04/25

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Basic information
Public title The effect of duloxetine in depression of menopose women
Acronym The effect of duloxetine in depression of menopose women
Scientific Title The effect of duloxetine in depression of menopose women
Scientific Title:Acronym The effect of duloxetine in depression of menopose women
Region
Japan

Condition
Condition depression of menopose women
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To consider the effect of duloxetine for menopausal depression
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of depression
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oral administration of duloxetine
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
40 years-old <=
Age-upper limit
55 years-old >=
Gender Female
Key inclusion criteria Menopausal patients who complain of depressive symptoms
Key exclusion criteria Patients with advanced renal function and liver dysfunction
Patients with refractory glaucoma
Patients who don not agree informed consent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Iwata
Organization Keio university school of medicine
Division name Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi Shinjyuku-ku Tokyo, Japan
TEL 03-3353-1211
Email iwatatakashi@1995.jukuin.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Iwata
Organization Keio university school of medicine
Division name Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi Shinjyuku-ku Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email iwatatakashi@1995.jukuin.keio.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology,Keio university school of medicine
Institute
Department

Funding Source
Organization Department of Obstetrics and Gynecology,Keio university school of medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 04 Month 25 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
2012 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 30 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
2015 Year 04 Month 25 Day
Last modified on
2015 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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