UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of electrocardiogram QT intervals prolongation after taking Escitalopram
Title of the study (Brief title)	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	Kenichi Osada
Organization	St. Marianna University School Of Medicine
Division name	Neuropsychiatry
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL	044-977-8111
Email	k2osada@marianna-u.ac.jp

Public contact
Name of contact person	Kenichi Osada
Organization	St. Marianna University School Of Medicine
Division name	Neuropsychiatry
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL	044-977-8111
Homepage URL
Email	k2osada@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School Of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017239