UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Aripiprazole versus duloxetine in combination with mirtazapine for treatment-resistant,major deressive disorder: a rater-masked,randomized trial.
Title of the study (Brief title)	Aripiprazole versus duloxetine in combination with mirtazapine for treatment-resistant,major deressive disorder:randomized trial.
Region	Japan

Condition
Condition	major depressive disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of study is to compare clinical efficacy and tolerability of aripiprazole versus duloxetine as combination treatment with mirtazapine in patients with resistant major depressive disorder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Hamilton Raing Scale for Depression
Key secondary outcomes	discontimuation rate, remission rate, adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Duloxetine
Interventions/Control_2	Aripiprazole
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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	DSM-4-TR:MDD Patients with treatment-resistant MDD: HAMD17>15:sufficient dose SSRI (ESC>15mg,PAR>30mg,SER>75mg,FLU>112,5mg) for more than 2 weeks. After that, the patients have no respose (HAMD17>15)to MIR 30mg/day for more than 2 weeks
Key exclusion criteria	Patient with the following disorders (based on DSM-IV-TR criteria): psychotic disorders, pervasive developmental disorders, bipolar disorder, obsessive-compulsive disorder, Axis-2 disorder. Patients with substance abuse or dependence (excluding nicotine and caffeine) meeting DSM-IV-TR criteria Patients taking MAO inhibitors with in14 days (or Patients treated with MAO inhibitors within 14 days) Patients taking pimozide Patients with allergies to escitalopram, duloxetine and aripiprazole Patients with QT interval prolongation Patients treated with ECT within the previous 6 months Patients having severe physical disease Patients who are pregnant or may become pregnant Patients at significant risk of suicide (having a score >3 on HAM-D item 11) Patients who had made suicide attempt within the past year
Target sample size	100

Research contact person
Name of lead principal investigator	Nakao Iwata
Organization	Fujita Health University School of Medicine
Division name	Department of Psychiatry
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL	0562-93-9250
Email	nakao@fujita-hu.ac.jp

Public contact
Name of contact person	Taro Kishi
Organization	Fujita Health University School of Medicine
Division name	Department of Psychiatry
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL	0562-93-9250
Homepage URL
Email	tarok@fujita-hu.ac.jp

Sponsor
Institute	Department of Psychiatry, Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	Department of Psychiatry, Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization	Other
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	2013 Year 08 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 14 Day
Anticipated trial start date	2013 Year 08 Month 14 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	2013 Year 08 Month 14 Day
Last modified on	2017 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013440