UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004567 |
|---|---|
| Receipt number | R000005448 |
| Scientific Title | The investigation of treatment for major depression compared monotherapy of mirtazapine, sertraline or duloxetine with combination therapy of mirtazapine and sertraline, or mirtazapine and duloxetine |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2017/04/17 16:27:20 |
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Basic information
Public title
The investigation of treatment for major depression compared monotherapy of mirtazapine, sertraline or duloxetine with combination therapy of mirtazapine and sertraline, or mirtazapine and duloxetine
Acronym
The investigation of treatment for major depression compared monotherapy of mirtazapine, sertraline or duloxetine with combination therapy of mirtazapine and sertraline, or mirtazapine and duloxetine
Scientific Title
The investigation of treatment for major depression compared monotherapy of mirtazapine, sertraline or duloxetine with combination therapy of mirtazapine and sertraline, or mirtazapine and duloxetine
Scientific Title:Acronym
The investigation of treatment for major depression compared monotherapy of mirtazapine, sertraline or duloxetine with combination therapy of mirtazapine and sertraline, or mirtazapine and duloxetine
Region
| Japan |
Condition
Condition
Major depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We examine the therapeutic efficacy and side effect compared the monotherapy (mirtazapine, sertraline or duloxetine)with the combination therapy (mirtazapine and sertraline or mirtazapine and duloxetine) for major depression, and investigation for polymorphism of serotonin 2A receptor, adrenergic alpha2a receptor and cytochrome P450 to the therapeutic efficacy and side effect
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
Pittsburgh Sleep Quality Index
Clinical Global Impression
The UKU side effect rating scale
Key secondary outcomes
Antidepressants side effect interview sheet (St. Marianna University School of Medicine version)
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug: mirtazapine
Period: 6 months
Dose: dose according to drug information
Interventions/Control_2
Drug: sertraline
Period: 6 months
Dose: dose according to drug information
Interventions/Control_3
Drug: duloxetine
Period: 6 months
Dose: dose according to drug information
Interventions/Control_4
Drug: mirtazapine and sertraline
Period: 6 months
Dose: dose according to drug information
Interventions/Control_5
Drug: mirtazapine and duloxetine
Period: 6 months
Dose: dose according to drug information
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 poit of teh item (No.1-17) of the Hamilton's deressive scale are more than 18 point.
Key exclusion criteria
The patints with a heavy suicide idea
The patints wuth severe physical diseases
Target sample size
500
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
Neuropsychiatry
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Osada |
Organization
St. Marianna University School of Medicine
Division name
Neuropsychiatry
Zip code
Address
TEL
Homepage URL
k2osada@marianna-u.ac.jp
Sponsor or person
Institute
Kenichi Osada
Institute
Department
Personal name
Funding Source
Organization
None
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 | 04 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 10 | Month | 29 | 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 | 11 | Month | 16 | Day |
Last modified on
| 2017 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005448
