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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024906
Receipt No. 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

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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
Email 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
Email agneau@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028645

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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