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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004567
Receipt No. 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

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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
Email

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
Email k2osada@marianna-u.ac.jp

Sponsor
Institute Kenichi Osada
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005448

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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