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The study of of Escitalopram ̓s effectiveness on treatment of mild to moderate depressive disorder and improvement of quality of life in patients who are undergone coronary artery bypass graft surgery (CABG) – A randomized double blind placebo controlled trial

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History
# Registration date Revision Id
4 2021-07-26, 1400/05/04 192071
3 2021-07-05, 1400/04/14 189140
2 2020-12-20, 1399/09/30 164354
1 2020-11-22, 1399/09/02 159827
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  • Protocol summary

    Patients who are undergoing Coronary Artery Bypass Graft surgery in Tehran Heart Center hospital are evaluated with Beck Depression Inventory and Quality of Life questionnaire (Short Form-36 ) and their demographic characteristics will be registered. BDI scores from 14 to 28 are Confirmed through clinical interview by a psychiatrist. patients are randomly divided into intervention group and control group.The study is blinded from the patients and the researcher. Both groups are treated for 8 weeks. During the second week and the fourth week of the treatment , patients are visited in the clinic in order to investigate side effects of drug. Questionnaires will be completed in the fourth week and the end of treatment (week 8)
    Patients who are undergoing Coronary Artery Bypass Graft surgery in Tehran Heart Center hospital are evaluated with Beck Depression Inventory and Quality of Life questionnaire (Short Form-36 ) and their demographic characteristics will be registered. BDI scores from 10 to 20 are Confirmed through clinical interview by a psychiatrist. patients are randomly divided into intervention group and control group.The study is blinded from the patients and the researcher. Both groups are treated for 8 weeks. During the second week and the fourth week of the treatment , patients are visited in the clinic in order to investigate side effects of drug. Questionnaires will be completed in the fourth week and the end of treatment (week 8)
    بیمارانی که تحت عمل جراحی بای پس عروق کرونر در بیمارستان مرکز قلب تهران قرار گرفته اند، تحت آزمونهای پرسشنامه افسردگی بک و پرسشـنامه کیفیت زندگی (فرم کوتاه -36) قرار میگیرند و مشخصـات دموگرافيـك آنها ثبت می شود. نمـره پرسشنامه افسردگی بک 14 تا 28 داشـته باشند توسط روانپزشک بر اساس مصاحبه بالینی تایید می شوند.بیماران به طور تصادفي در دو گروه مداخله و شاهد تقسيم می شوند. مطالعه از دید بیماران و پژوهشگر طرح کورسازی میشود. هردو گروه به مدت 8 هفته درمان میشوند. بیماران در هفته ی دوم و چهارم درمان جهت بررسی عوارض دارویی در درمانگاه ویزیت میشوند . در هفته 4 و اتمام درمان (هفته 8) پرسشنامه ها تکمیل خواهد شد.
    بیمارانی که تحت عمل جراحی بای پس عروق کرونر در بیمارستان مرکز قلب تهران قرار گرفته اند، تحت آزمونهای پرسشنامه افسردگی بک و پرسشـنامه کیفیت زندگی (فرم کوتاه -36) قرار میگیرند و مشخصـات دموگرافيـك آنها ثبت می شود. نمـره پرسشنامه افسردگی بک 10 تا 20 داشـته باشند توسط روانپزشک بر اساس مصاحبه بالینی تایید می شوند.بیماران به طور تصادفي در دو گروه مداخله و شاهد تقسيم می شوند. مطالعه از دید بیماران و پژوهشگر طرح کورسازی میشود. هردو گروه به مدت 8 هفته درمان میشوند. بیماران در هفته ی دوم و چهارم درمان جهت بررسی عوارض دارویی در درمانگاه ویزیت میشوند . در هفته 4 و اتمام درمان (هفته 8) پرسشنامه ها تکمیل خواهد شد.
    inclution critria: coronary artery bypass graft surgery ,Age (18-75), Beck Depression Inventory score (14-28), exclusion critria: Previous history of intolerance to SSRI ,Psychosis or dementia or mental retardation disorder ,Severe liver disease,High risk of postoperative cardiac complications such as bleeding, participating in other trials, History of Bipolar Disorder, Patients who have been treated with escitalopram or an antidepressant during the previous month, Recent alcohol and substances abuse,Pregnancy and lactation
    inclution critria: coronary artery bypass graft surgery ,Age (18-75), Beck Depression Inventory score (10-20), exclusion critria: Previous history of intolerance to SSRI ,Psychosis or dementia or mental retardation disorder ,Severe liver disease,High risk of postoperative cardiac complications such as bleeding, participating in other trials, History of Bipolar Disorder, Patients who have been treated with escitalopram or an antidepressant during the previous month, Recent alcohol and substances abuse,Pregnancy and lactation
    معيار ورود : جراحی بای پس عروق قلب ، سن 18-75 سال، بيماراني كه نمره پرسشنامه افسردگی بک 14-28 دارند، معيار خروج : سابقه قبلي عدم تحمـل داروهـاي مهارکننده بازجذب سروتونین، سايكوز یا دمانس یا اختلال عقب ماندگي ذهنـي در بيمار، بیماری شدید کبدی، ریسک بالای عوارض قلبی بعد از عمل نظیر خونریزی، شرکت در کارآزمایی های دیگر، سابقه اختلال دوقطبی، بیمارانی که طی یکماه قبل تحت درمان با اس سیتالوپرام یا داروی آنتی دپرسانت بوده اند، سومصرف اخیر الکل و مواد، بارداری و شیرهی
    معيار ورود : جراحی بای پس عروق قلب ، سن 18-75 سال، بيماراني كه نمره پرسشنامه افسردگی بک 10-20 دارند، معيار خروج : سابقه قبلي عدم تحمـل داروهـاي مهارکننده بازجذب سروتونین، سايكوز یا دمانس یا اختلال عقب ماندگي ذهنـي در بيمار، بیماری شدید کبدی، ریسک بالای عوارض قلبی بعد از عمل نظیر خونریزی، شرکت در کارآزمایی های دیگر، سابقه اختلال دوقطبی، بیمارانی که طی یکماه قبل تحت درمان با اس سیتالوپرام یا داروی آنتی دپرسانت بوده اند، سومصرف اخیر الکل و مواد، بارداری و شیرهی

  • General information

    2021-02-19, 1399/12/01
    2021-06-20, 1400/03/30
    empty
    Edit study execution time and Beck questionnaire score
    empty
    ویرایش زمان اجرای مطالعه و نمره ی پرسشنامه بک
    coronary artery bypass graft surgery
    Age >18 (18-75)
    patient with beck depression inventory score 14-28
    coronary artery bypass graft surgery
    Age >18 (18-75)
    patient with beck depression inventory score 10-20
    جراحی عروق کرونر قلب
    سن بالاي 18 سال (18-75)
    بيماراني كه نمره پرسشنامه بک 14-28 باشد
    جراحی عروق کرونر قلب
    سن بالاي 18 سال (18-75)
    بيماراني كه نمره پرسشنامه بک 10-20 باشد

  • Recruitment centers

    #1
    Name of recruitment center - English: dr shareati hospital and tehran heart center
    Name of recruitment center - Persian: بیمارستان دکتر شریعتی و مرکز قلب تهران
    Full name of responsible person - English: dr.abdolvahab baradaran
    Full name of responsible person - Persian: دکتر عبدالوهاب برادران
    Street address - English: Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St.
    Street address - Persian: تهران، خیابان کارگر شمالی، سه راه جلال آل احمد،مرکز آموزشی پژوهشی و درمانی بیمارستان شريعتي
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1321465780
    Phone: +98 21 3340 1604
    Fax:
    Email: abdolvahab_baradaran@yahoo.com
    Web page address:
    Name of recruitment center - English: Tehran Heart Center Hospital
    Name of recruitment center - Persian: بیمارستان مرکز قلب تهران
    Full name of responsible person - English: Dr.Fatemeh Asadian Kuhestani
    Full name of responsible person - Persian: دکتر فاطمه اسدیان کوهستانی
    Street address - English: Tehran Heart Research Center., Tehran Heart Center Hospital., North Kargar Street., Jalal Al-Ahmad Highway
    Street address - Persian: بزرگراه جلال آل احمد، خیابان کارگر شمالی، بیمارستان مرکز قلب تهران، مرکز تحقیقات قلب
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1321465780
    Phone: +98 21 8802 9256
    Fax: +98 21 8802 9731
    Email: F.asadian1392@gmail.com
    Web page address: http://thc.tums.ac.ir/v-1022/

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Mohammad Reza khodaie Ardakani
    Full name of responsible person - Persian: دکتر محمدرضا خدایی اردکانی
    Street address - English: Vice chancellor for research, University of Social Welfare & Rehabilitation Sciences, koodakiar st., Velenjac, Tehran
    Street address - Persian: تهران ، ولنجک ، کودکیار ، دانشگاه علوم بهزیستی و توانبخشی
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 132415
    Phone: +98 21 3340 1604
    Fax:
    Email: kh.ardakani@uswr.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Mohammad Reza khodaie Ardakani
    Full name of responsible person - Persian: دکتر محمدرضا خدایی اردکانی
    Street address - English: Vice Chancellor for Research., University of Social Welfare & Rehabilitation Sciences., Koodakyar st., Velenjac
    Street address - Persian: ولنجک، خیابان کودکیار ، دانشگاه علوم بهزیستی و توانبخشی، معاونت پژوهشي
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1324159876
    Phone: +98 21 2218 0093
    Fax:
    Email: kh.ardakani@uswr.ac.ir
    Web page address:

Protocol summary

Study aim
The study of Escitalopram ̓s effectiveness on treatment of mild to moderate depressive disorder and improvement of quality of life in patients who are undergone coronary artery bypass graft surgery
Design
Clinical trial with control group, double-blind, randomized on 100 patients. Randomization using the software
Settings and conduct
Patients who are undergoing Coronary Artery Bypass Graft surgery in Tehran Heart Center hospital are evaluated with Beck Depression Inventory and Quality of Life questionnaire (Short Form-36 ) and their demographic characteristics will be registered. BDI scores from 10 to 20 are Confirmed through clinical interview by a psychiatrist. patients are randomly divided into intervention group and control group.The study is blinded from the patients and the researcher. Both groups are treated for 8 weeks. During the second week and the fourth week of the treatment , patients are visited in the clinic in order to investigate side effects of drug. Questionnaires will be completed in the fourth week and the end of treatment (week 8)
Participants/Inclusion and exclusion criteria
inclution critria: coronary artery bypass graft surgery ,Age (18-75), Beck Depression Inventory score (10-20), exclusion critria: Previous history of intolerance to SSRI ,Psychosis or dementia or mental retardation disorder ,Severe liver disease,High risk of postoperative cardiac complications such as bleeding, participating in other trials, History of Bipolar Disorder, Patients who have been treated with escitalopram or an antidepressant during the previous month, Recent alcohol and substances abuse,Pregnancy and lactation
Intervention groups
intervention group: tablet escitalopram 10 mg (Selective Serotonin Reuptake Inhibitors) and control group : tablet placebo , both drugs produced by Abidi company ,once a day ,one tablet, for 8 weeks
Main outcome variables
Depression؛ Quality of life

General information

Reason for update
Edit study execution time and Beck questionnaire score
Acronym
IRCT registration information
IRCT registration number: IRCT20140126016374N2
Registration date: 2020-11-22, 1399/09/02
Registration timing: registered_while_recruiting

Last update: 2020-12-24, 1399/10/04
Update count: 3
Registration date
2020-11-22, 1399/09/02
Registrant information
Name
Mohammad Reza Khodaie Ardakani
Name of organization / entity
University of Social Welfare & Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3340 1604
Email address
kh.ardakani@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of of Escitalopram ̓s effectiveness on treatment of mild to moderate depressive disorder and improvement of quality of life in patients who are undergone coronary artery bypass graft surgery (CABG) – A randomized double blind placebo controlled trial
Public title
Escitalopram ̓s effectiveness on treatment of depressive disorder and improvement of quality of life in patients who are undergone coronary artery bypass graft surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
coronary artery bypass graft surgery Age >18 (18-75) patient with beck depression inventory score 10-20
Exclusion criteria:
Previous history of intolerance to serotonin reuptake inhibitor antidepressants Psychosis or dementia or mental retardation disorder in the patient Severe liver disease High risk of postoperative cardiac complications such as bleeding Patients participating in other trials History of bipolar disorder Patients who have been treated with escitalopram or an antidepressant during the previous month Recent abuse of alcohol and substances Pregnancy and lactation
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization using a computer randomization method, in this method we randomly place each client in the intervention or control group. Randomization unit: individual, Randomization tool and randomization sequence: determined by excel software and RAND Function. allocation concealment: The type of treatment allocated in the two groups is completely unpredictable. Assignment to groups is also hidden from the researcher and patients by coding the drug and placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This clinical trial is blinded so that the participants, the clinician, , principle researcher,data collector and outcome evaluator do not have any info about the assignment of individuals to the groups. The evaluation of the subjects is done by the external evaluator who is not involved in the research team. The main drug and placebo that are similar (in terms of odour, color, shape and taste) are placed in similar cans having the same weight by a person who is not a member of the research team. Drugs are coded based on random sequence in two groups ( A) and (B) and they are numbred randomly. A unique code is assigned to each patient .The researcher provides the drug to the participant according to the coding.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethis committee of University of Social Welfare & Rehabilitation sciences
Street address
University of Social Welfare & Rehabilitation Sciences، Koodakyar street، Velenjac
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2020-09-18, 1399/06/28
Ethics committee reference number
IR.USWR.REC.1399.159

Health conditions studied

1

Description of health condition studied
Depression Disorder
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes

Primary outcomes

1

Description
degree of Depression
Timepoint
Beginning of the study (before the intervention)؛ Week 4؛ Week 8 (after treatment)؛
Method of measurement
Beck Depression Inventory (BDI-II)

2

Description
quality of life
Timepoint
Beginning of the study (before the intervention)؛ Week 4 ؛ Week 8 (after treatment)؛
Method of measurement
Quality of Life questionnaire ، 36-Item Short Form (SF-36)

Secondary outcomes

1

Description
Drug complication
Timepoint
2 and 4 weeks after taking the drug
Method of measurement
Checklist of drug side effects

Intervention groups

1

Description
Intervention group: take escitalopram 10 mg؛ once daily ؛ oral ؛ pruduct by Abidi company ؛For 8 weeks
Category
Treatment - Drugs

2

Description
Control group: take placebo tablet ؛ Produced by Abaidi Company؛ once daily ؛ Oral ؛ For 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center Hospital
Full name of responsible person
Dr.Fatemeh Asadian Kuhestani
Street address
Tehran Heart Research Center., Tehran Heart Center Hospital., North Kargar Street., Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1321465780
Phone
+98 21 8802 9256
Fax
+98 21 8802 9731
Email
F.asadian1392@gmail.com
Web page address
http://thc.tums.ac.ir/v-1022/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Mohammad Reza khodaie Ardakani
Street address
Vice Chancellor for Research., University of Social Welfare & Rehabilitation Sciences., Koodakyar st., Velenjac
City
Tehran
Province
Tehran
Postal code
1324159876
Phone
+98 21 2218 0093
Email
kh.ardakani@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fatemeh Asadian Kuhestani
Position
Psychiatry Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Razi psychiatric Hospital ، shahre Rey، Tehran
City
Tehran
Province
Tehran
Postal code
1313913139
Phone
+98 21 3340 1604
Email
f.asadian1392@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Mohammad Reza khodaie Ardakani
Position
psychiatrist-Associated professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Razi psychiatric Hospital ، Shahre Rey، Tehran
City
Tehran
Province
Tehran
Postal code
1313913139
Phone
+98 21 3340 1604
Email
kh.ardakani@uswr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fatemeh Asadian Kuhestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Razi psychiatric Hospital ، Shahre Rey، Tehran
City
Tehran
Province
Tehran
Postal code
1313913139
Phone
+98 21 3340 1604
Email
f.asadian1392@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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