UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Kenichi Osada
Organization	St. Marianna University School Of Medicine
Division name	Neuropsychiatry
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL	044-977-8111
Email

Public contact
Name of contact person	Kenichi Osada
Organization	St. Marianna University School of Medicine
Division name	Neuropsychiatry
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 10 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005448