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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011483
Receipt No. R000013440
Scientific Title Aripiprazole versus duloxetine in combination with mirtazapine for treatment-resistant,major deressive disorder: a rater-masked,randomized trial.
Date of disclosure of the study information 2013/08/14
Last modified on 2017/02/15

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Basic information
Public title Aripiprazole versus duloxetine in combination with mirtazapine for treatment-resistant,major deressive disorder: a rater-masked,randomized trial.
Acronym Aripiprazole versus duloxetine in combination with mirtazapine for treatment-resistant,major deressive disorder:randomized trial.
Scientific Title Aripiprazole versus duloxetine in combination with mirtazapine for treatment-resistant,major deressive disorder: a rater-masked,randomized trial.
Scientific Title:Acronym 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
1st name
Middle name
Last name Nakao Iwata
Organization Fujita Health University School of Medicine
Division name Department of Psychiatry
Zip code
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
1st name
Middle name
Last name Taro Kishi
Organization Fujita Health University School of Medicine
Division name Department of Psychiatry
Zip code
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)

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
2013 Year 08 Month 14 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
2013 Year 08 Month 14 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000013440

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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