UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006386 |
|---|---|
| Receipt number | R000007578 |
| Scientific Title | Investigation on the effects of duloxetine on depressive symptoms and sleep disturbances |
| Date of disclosure of the study information | 2011/09/21 |
| Last modified on | 2011/09/21 19:00:19 |
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Basic information
Public title
Investigation on the effects of duloxetine on depressive symptoms and sleep disturbances
Acronym
Effect of duloxetine on depression and sleep disturbances
Scientific Title
Investigation on the effects of duloxetine on depressive symptoms and sleep disturbances
Scientific Title:Acronym
Effect of duloxetine on depression and sleep disturbances
Region
| Japan |
Condition
Condition
major depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the therapeutical effects of duloxetine on depressive symptoms and sleep disturbances.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
polysomnography, actigram, Hamiton's rating scale for depression
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
Patients 1) who are diagnosed as major depressive disorder (DSM-IV), 2) whose HSM-D score is higher than 10, and 3) who understand the points of this study and give informed-consent in literature.
Key exclusion criteria
Patients 1) who meet criteria for any axis II diagnosis (DSM-IV), 2) who have severe medical illness that may prevent the study, 3) who are not appropriate for duloxetine prescription.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideto Shinno |
Organization
Kagawa University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
087-891-2167
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideto Shinno |
Organization
Kagawa University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
087-891-2167
Homepage URL
shinnoh@med.kagawa-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kagawa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neuropsychiatry, Kagawa 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
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
| 2011 | Year | 09 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
Outcomes of depressive symptoms and sleep disturbances under/after treatment are observed.
Management information
Registered date
| 2011 | Year | 09 | Month | 21 | Day |
Last modified on
| 2011 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007578
| Research Plan | |
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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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