UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004667 |
|---|---|
| Receipt number | R000005558 |
| Scientific Title | Investigation for polymorphism of serotonin 3 receptors to the side effect after treatment with milnacipran and sertraline |
| Date of disclosure of the study information | 2011/01/01 |
| Last modified on | 2015/06/04 17:41:13 |
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Basic information
Public title
Investigation for polymorphism of serotonin 3 receptors to the side effect after treatment with milnacipran and sertraline
Acronym
Investigation for polymorphism of the side effect after treatment with milnacipran and sertraline
Scientific Title
Investigation for polymorphism of serotonin 3 receptors to the side effect after treatment with milnacipran and sertraline
Scientific Title:Acronym
Investigation for polymorphism of the side effect after treatment with milnacipran and sertraline
Region
| Japan |
Condition
Condition
Major depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Investigation for polymorphism of serotonin 3 receptors to the side effect after treatment with milnacipran and sertraline for Major depression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hamilton's Rating Scale for Depression
SF-36
Key secondary outcomes
The UKU side effect rating scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug:Milnacipran
Period:8 weeks
Dose:dose according to drug information
Interventions/Control_2
Drug:Sertraline
Period:8 weeks
Dose:dose according to drug information
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients that the total point of the item (No. 1-17) of the Hamilton depressive scale (HAMD) are more than 18 point, and the depressive mood score is more than 2 point.
Key exclusion criteria
The patients have a heavy suicidal idea.
The patients have severe physical diseases.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Osada |
Organization
St. Marianna University School of Medicine
Division name
Neuropshyciatry
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki
TEL
044-977-8111
k2osada@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Osada |
Organization
St. Marianna University School of Medicine
Division name
Neuropshyciatry
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki
TEL
044-977-8111
Homepage URL
k2osada@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Dep. Neuropshyciatry
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 | 01 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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
| 2010 | Year | 12 | Month | 04 | Day |
Last modified on
| 2015 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005558
