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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004667
Receipt No. 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

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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
Email 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
Email k2osada@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine, Dep. Neuropshyciatry
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005558

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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