UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011483 |
|---|---|
| Receipt number | 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 11:36:41 |
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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
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
tarok@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013440
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| Registered date | File name |
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| Registered date | File name |
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