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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009354
Receipt No. R000010986
Scientific Title Effects of selective sertonin reuptake inhibitors on subjective and objective sleep parameters in middle-aged women with depression
Date of disclosure of the study information 2012/11/19
Last modified on 2015/09/26

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Basic information
Public title Effects of selective sertonin reuptake inhibitors on subjective and objective sleep parameters in middle-aged women with depression
Acronym Effects of selective sertonin reuptake inhibitors on subjective and objective sleep parameters in middle-aged women with depression
Scientific Title Effects of selective sertonin reuptake inhibitors on subjective and objective sleep parameters in middle-aged women with depression
Scientific Title:Acronym Effects of selective sertonin reuptake inhibitors on subjective and objective sleep parameters in middle-aged women with depression
Region
Japan

Condition
Condition menopausal depression
Classification by specialty
Obsterics and gynecology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of two SSRIs on subjective and objective sleep paraeters in middle-aged women with depression
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Athens Insomnia Scale
Actigram
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 8-week treatment with 10 mg of escitalopram
Interventions/Control_2 8-week treatment with 12.5-25 mg of paroxetine CR
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
65 years-old >
Gender Female
Key inclusion criteria women with depressive symptoms
Key exclusion criteria women who are treated with estrogens, Kampo medicine, psychotropic agents etc.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Terauchi
Organization Tokyo Medical and Dental University
Division name Department of Women's Health
Zip code
Address Yushima 1-5-45, Bunkyo, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Medical and Dental University
Division name Department of Women's Health
Zip code
Address
TEL
Homepage URL
Email teragyne@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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
2012 Year 11 Month 19 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 Terminated
Date of protocol fixation
2012 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 19 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
2012 Year 11 Month 17 Day
Last modified on
2015 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010986

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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