|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000014832 |
|
Date of registration:
|
15/08/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Examination of electrocardiogram QT intervals prolongation after taking Escitalopram
|
|
Scientific title:
|
Examination of electrocardiogram QT intervals prolongation after taking Escitalopram - Examination of electrocardiogram QT intervals prolongation after taking Escitalopram |
|
Date of first enrolment:
|
2014/08/20 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017239 |
|
Study type:
|
Interventional |
|
Study design:
|
Single arm Non-randomized
|
|
Phase:
|
Not selected
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Kenichi Osada |
|
Address:
|
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
Japan |
|
Telephone:
|
044-977-8111 |
|
Email:
|
k2osada@marianna-u.ac.jp |
|
Affiliation:
|
St. Marianna University School Of Medicine Neuropsychiatry |
|
|
Name:
|
Kenichi Osada |
|
Address:
|
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
Japan |
|
Telephone:
|
044-977-8111 |
|
Email:
|
k2osada@marianna-u.ac.jp |
|
Affiliation:
|
St. Marianna University School Of Medicine Neuropsychiatry |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Major Depressive Disorder
|
|
Intervention(s)
|
|
Escitalopram
|
|
Primary Outcome(s)
|
|
Confirmation of the QT prolonged with taking Escitalopram
|
|
Secondary Outcome(s)
|
|
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
|
|
Source(s) of Monetary Support
|
|
Mitsubishi Tanabe Pharma
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|