UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024906 |
|---|---|
| Receipt number | R000028645 |
| Scientific Title | Efficacy and tolerability comparing switching escitalopram to mirtazapine and mirtazapine augmentation to escitalopram with major depressive disorder with insufficiency in escitalopram. A randomized rater blinded randomized controlled trial. |
| Date of disclosure of the study information | 2016/11/19 |
| Last modified on | 2018/05/22 09:59:53 |
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Basic information
Public title
Efficacy and tolerability comparing switching escitalopram to mirtazapine and mirtazapine augmentation to escitalopram with major depressive disorder with insufficiency in escitalopram. A randomized rater blinded randomized controlled trial.
Acronym
Efficacy and tolerability comparing switching escitalopram to mirtazapine and mirtazapine augmentation to escitalopram with major depressive disorder with insufficiency in escitalopram. A randomized rater blinded randomized controlled trial.
Scientific Title
Efficacy and tolerability comparing switching escitalopram to mirtazapine and mirtazapine augmentation to escitalopram with major depressive disorder with insufficiency in escitalopram. A randomized rater blinded randomized controlled trial.
Scientific Title:Acronym
Efficacy and tolerability comparing switching escitalopram to mirtazapine and mirtazapine augmentation to escitalopram with major depressive disorder with insufficiency in escitalopram. A randomized rater blinded randomized controlled trial.
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal which switching escitalopram to mirtazapine or mirtazapine augmentation to escitalopram are beneficial to the patients with major depressive disorder who were insufficient with escitalopram.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in remission rate between escitalopram to mirtazapine switching group and mirtazapine augmentation to escitalopram group from baseline to week 12.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching 5-20mg/day of escitalopram to 15-45mg/day of mirtazapine.
Interventions/Control_2
Augmentation of 15-45mg/day of mirtazapine to 5-20mg/day of escitalopram.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients provided written informed consent.
2.Legal representative provided informed consent if the patient has poor judgement.
3.Diagnosis of major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders, fourth edition.
4.Scores of Hamilton Rating Scale for Depression 17 items are over 12 points with more than 2 weeks of approved dose of escitalopram.
Key exclusion criteria
1.Patients diagnosed as pervasive development disorder, schizophrenia and related psychosis, bipolar disorder, or obsessive compulsive disorder on axis one of the Diagnostic and Statistical Manual of Mental Disorders,fourth edition.(using the structured clinical interview for DSM-four axis one disorders)
2.Patients diagnosed as personality disorder or mental retardation on axis two of the Diagnostic and Statistical Manual of Mental Disorders,fourth edition.
3.Patients diagnosed as substance abuse or dependence.(but,dependence of nicotine or caffeine are inclusive)
4.Patients having allergy for escitalopram or mirtazapine.
5.Patients taking monoamine oxidase inhibitor within 2 weeks.
6.Patients taking pimozide
7.Patients diagnosed QTc prolongation (congenital long QT syndrome)
8.Patients treated with electroconvulsive therapy within 6 months
9.Patients diagnosed severe disease with liver, kidney, blood, respiratory organ, digestive organ, abnormality in metabolism and electrolytes or hypersensitivity.
10.Patients taking treatment for physical disease.
11.Patients who may be pregnant and pregnant.
12.Patients judged high risk for suicide.
13.Patients attempted suicide.
14.Patients judged inappropriate for participation by researchers.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakao Iwata |
Organization
Fujita Health University
Division name
department of psychiatry
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9250
agneau@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuto Oya |
Organization
Fujita Health University
Division name
department of psychiatry
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9250
Homepage URL
agneau@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
self-sustaining from Fujita Health University
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
Secondary IDs
Secondary IDs
YES
Study ID_1
HM16-134
Org. issuing International ID_1
Fujita Health University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 19 | 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
| 2016 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 19 | 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
| 2016 | Year | 11 | Month | 19 | Day |
Last modified on
| 2018 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028645
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