UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014609 |
|---|---|
| Receipt number | R000016997 |
| Scientific Title | The head-to-head comparison between escitalopram and mirtazapine for anxiety and agitation on the patients with depression, especially for the efficacy and safety. |
| Date of disclosure of the study information | 2014/07/23 |
| Last modified on | 2020/01/25 09:40:39 |
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Basic information
Public title
The head-to-head comparison between escitalopram and mirtazapine for anxiety and agitation on the patients with depression, especially for the efficacy and safety.
Acronym
The head-to-head comparison between escitalopram and mirtazapine on the patients with depression.
Scientific Title
The head-to-head comparison between escitalopram and mirtazapine for anxiety and agitation on the patients with depression, especially for the efficacy and safety.
Scientific Title:Acronym
The head-to-head comparison between escitalopram and mirtazapine on the patients with depression.
Region
| Japan |
Condition
Condition
depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the difference of efficacy on anxiety and agitation of escitalopram and mirtazapine for depression patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical symptom scaled by HAM-A, HAM-D, and MADRS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
escitalopram
Interventions/Control_2
mirtazapine
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The adult patients with depression
Key exclusion criteria
The patients who does not have the insight
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tetsufumi |
| Middle name | |
| Last name | Kanazawa |
Organization
Osaka Medical College
Division name
Neuropsychiatry dept
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki-city, Osaka, Japan
TEL
072-683-1221
psy052@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Tetsufumi |
| Middle name | |
| Last name | Kanazawa |
Organization
Osaka Medical College
Division name
Neuropsychiatry dept
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki-city, Osaka, Japan
TEL
072-683-1221
Homepage URL
psy052@poh.osaka-med.ac.jp
Sponsor or person
Institute
Neuropsychiatry dept., Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Neuropsychiatry dept., Osaka Medical College
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
Osaka Medical College
Address
2-7 Daigaku-machi, Takatsuki-city, Osaka, Japan
Tel
072-683-1221
rinri@art.osaka-med.ac.jp
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
| 2014 | Year | 07 | Month | 23 | 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
Suspended
Date of protocol fixation
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016997
