UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014832 |
|---|---|
| Receipt number | R000017239 |
| Scientific Title | Examination of electrocardiogram QT intervals prolongation after taking Escitalopram |
| Date of disclosure of the study information | 2014/08/15 |
| Last modified on | 2018/10/10 15:21:26 |
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Basic information
Public title
Examination of electrocardiogram QT intervals prolongation after taking Escitalopram
Acronym
Examination of electrocardiogram QT intervals prolongation after taking Escitalopram
Scientific Title
Examination of electrocardiogram QT intervals prolongation after taking Escitalopram
Scientific Title:Acronym
Examination of electrocardiogram QT intervals prolongation after taking Escitalopram
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the correlation between QT intervals measured by a 12 resting ECG and those measured by an ambulatory electrocardiogram, among the patients who are taking escitalopram, an antidepressant drug. After that, we examine whether the ambulatory electrocardiogram can discern the QT intervals which were prolonged by the drug. And we also examine whether the prolonged QT intervals correlate genetic polymorphism and the drug level each other.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirmation of the QT prolonged with taking Escitalopram
Key secondary outcomes
1)Correlation of the QT intervals measured by 12 instruction and mobile electrocardiograph
2)Prevalence of the QT value over 500msec
3)Observation of the QT value area according to the subjects background factor
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Escitalopram
Interventions/Control_2
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
1) The patient with major depressive disorder to meet a criteria of DSM-V
2) The patient who is over 20 years old at the agreement acquisition
3) The patient who understands enough the explanation about this examination and agrees on this study
Key exclusion criteria
1) The patient with a history of hypersensitivity for the ingredient of the study drug
2) The patient who is taking a monoamine oxidase (MAO) inhibitor or the patient who stops taking the drug within 14 days
3) The patient who is taking Pimozide
4) The patient who has QT interval over 500 msec
5) The patient who has long QT syndrome and arrhythmia to need treatment or the heart disorder (coronary artery disease, myocardial desease, valve disorder and heart failure)
6) The patient who is regarded as the inappropriate person by a doctor who is in charge of the examination
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Osada |
Organization
St. Marianna University School Of Medicine
Division name
Neuropsychiatry
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
k2osada@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Osada |
Organization
St. Marianna University School Of Medicine
Division name
Neuropsychiatry
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
k2osada@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School Of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 08 | Month | 15 | 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
| 2014 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 11 | Day |
Last modified on
| 2018 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017239
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
