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Evaluation of the effect of Escitalopram versus placebo trial on changing the neuroticism

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History
# Registration date Revision Id
2 2022-09-03, 1401/06/12 240381
1 2022-07-03, 1401/04/12 232069
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  • Protocol summary

    This clinical trial will be performed on 172 patients with control group, in parallel. Participants in this study will be blind to the type of intervention. The aim of this intervention is to evaluate the effect of Citalopram vs. placebo on altering the neuroticism traits. This study will be performed on patients hospitalized in Ahvaz. Patient allocation will be non-random.
    This clinical trial will be performed on 172 patients with control group, in parallel. Participants in this study will be blind to the type of intervention. The aim of this intervention is to evaluate the effect of Citalopram vs. placebo on altering the neuroticism traits. This study will be performed on residents in Ahvaz. Patient allocation will be non-random.
    این کارآزمایی بالینی بر روی 172نفر بیمار، دارای گروه کنترل، با گروه های موازی ، انجام خواهد شد. شرکت کنندگان در این پژوهش نسب به نوع مداخله کور خواهند بود. مداخله مد نظر بررسی تأثیر داروی اس سیتالوپرام در برابر پلاسبو در تغییر صفات مزاجی نوروتیزیم است. این مطالعه بر روی بیماران بستری در اهواز انجام خواهد شد. اختصاص بیماران به صورت غیر تصادفی خواهد بود
    این کارآزمایی بالینی بر روی 172نفر بیمار، دارای گروه کنترل، با گروه های موازی ، انجام خواهد شد. شرکت کنندگان در این پژوهش نسب به نوع مداخله کور خواهند بود. مداخله مد نظر بررسی تأثیر داروی اس سیتالوپرام در برابر پلاسبو در تغییر صفات مزاجی نوروتیزیم است. این مطالعه بر روی رزیدنت ها در اهواز انجام خواهد شد. اختصاص بیماران به صورت غیر تصادفی خواهد بود

  • General information

    2022-11-21, 1401/08/30
    2022-09-06, 1401/06/15
    empty
    In the abstract part of the protocol, the method and place of the study needed to be amended. (Inpatients have been written incorrectly). The people under investigation are residents of Golestan, Razi and Imam hospitals in Ahvaz. They are not "hospitalized".
    empty
    در قسمت چکیده پروتکل، نحوه و محل انجام مطالعه نیاز به اصلاحیه وجود داشت. ( بیماران بستری اشتباه نوشته شده است). افراد مورد بررسی رزیدنت های بیمارستان‌های گلستان، رازی و امام در اهواز می‌باشند. "بستری" نیستند.

  • Recruitment centers

    #1
    Name of recruitment center - English: Golestan, Razi, and Imam hospitals in Ahvaz
    Name of recruitment center - Persian: بیمارستان گلستان .رازی .امام در اهواز
    Full name of responsible person - English: mina kianmanesh rad
    Full name of responsible person - Persian: مینا کیان منش راد
    Street address - English: no 45.mehre 2 ave .fatemeye ave .gheytariye ave . tehran
    Street address - Persian: تهران خيابان قيطريه فاطميه مهر دو پلاک 45 طبقه 5 شرقي
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 1933655181
    Phone: +98 902 594 3609
    Fax:
    Email: minakianmanesh69@gmail.com
    Web page address:
    Name of recruitment center - English: Golestan Hospital
    Name of recruitment center - Persian: بیمارستان گلستان
    Full name of responsible person - English: Mina Kianmanesh Rad
    Full name of responsible person - Persian: مینا کیان منش راد
    Street address - English: َGolestan Hospital, Golestan Blvd., Ahvaz
    Street address - Persian: اهواز .بلوار گلستان، بیمارستان گلستان
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6135733118
    Phone: +98 902 594 3609
    Fax:
    Email: minakianmanesh69@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: razi hospital
    Name of recruitment center - Persian: بیمارستان رازی
    Full name of responsible person - English: mina kianmanesh rad
    Full name of responsible person - Persian: مینا کیان منش راد
    Street address - English: 4th floor no 143 golestan ave .mehre ave between bahman and esfand ahvaz town
    Street address - Persian: اهواز .گلستان. خیابان مهر بین بهمن و اسفند پلاک 143 طبقه 4
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6135944721
    Phone: +98 902 594 3609
    Fax:
    Email: minakianmanesh69@gmail.com
    Web page address:
    Name of recruitment center - English: Razi hospital
    Name of recruitment center - Persian: بیمارستان رازی
    Full name of responsible person - English: Mina Kianmanesh Rad
    Full name of responsible person - Persian: مینا کیان منش راد
    Street address - English: Razi Hospital, Palestine Blvd., Ahvaz,
    Street address - Persian: اهواز، بلوار فلسطین، بیمارستان رازی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 1494161956
    Phone: +98 902 594 3609
    Fax:
    Email: minakianmanesh69@gmail.com
    Web page address:
    #3
    Name of recruitment center - English: emam khomeyni hospital
    Name of recruitment center - Persian: بیمارستان امام خمینی
    Full name of responsible person - English: mina kianmanesh rad
    Full name of responsible person - Persian: مینا کیان منش راد
    Street address - English: 4th floorno 143 golestan ave .mehre ave between bahman and esfand ahvaz town
    Street address - Persian: اهواز .گلستان. خیابان مهر بین بهمن و اسفند پلاک 143 طبقه 4
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6135944721
    Phone: +98 902 594 3609
    Fax:
    Email: minakianmanesh69@gmail.com
    Web page address:
    Name of recruitment center - English: Emam Khomeyni hospital
    Name of recruitment center - Persian: بیمارستان امام خمینی
    Full name of responsible person - English: Mina Kianmanesh Rad
    Full name of responsible person - Persian: مینا کیان منش راد
    Street address - English: Imam Khomeyni hospital, Azadegan Street, Ahvaz
    Street address - Persian: اهواز، خیابان آزادگان، بیمارسان امام خمینی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6193673111
    Phone: +98 902 594 3609
    Fax:
    Email: minakianmanesh69@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr zakerkish
    Full name of responsible person - Persian: دکتر ذاکرکیش
    Street address - English: no45. mehre 2 ave . fatemiyeh ave . gheytariye ave . tehran
    Street address - Persian: تهران خيابان قيطريه فاطميه مهر دو پلاک 45 طبقه 5 شرقي
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 1933655181
    Phone: +98 902 594 3609
    Fax:
    Email: minakianmanesh69@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ahmad Fakhri
    Full name of responsible person - Persian: احمد فخری
    Street address - English: Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
    Street address - Persian: اهواز .بلوار گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6135715794
    Phone: +98 902 594 3609
    Fax:
    Email: fakhri_a@ajums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    yes
    undecided
    yes
    There is no plan to subscribe to it
    After the article is published, the results will be available to the public.
    برنامه ای برای اشتراک آن وجود ندارد
    پس از چاپ مقاله نتایج در دسترس عموم قرار خواهد گرفت.
    I have not decided yet - the release schedule is not yet known
    After the article is published, the results will be available to the public.
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
    پس از چاپ مقاله نتایج در دسترس عموم قرار خواهد گرفت.
    I have not decided yet - the release schedule is not yet known
    After the article is published, the results will be available to the public.
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
    پس از چاپ مقاله نتایج در دسترس عموم قرار خواهد گرفت.

Protocol summary

Study aim
Evaluation of the effect of Escitalopram versus placebo on changing the neuroticism
Design
The subjects are residents of Golestan, Razi, and Imam hospitals in Ahvaz. Neurotomy will be assessed by conducting an initial interview and using the 60-item NEO-60 questionnaire at the beginning of the study, and if the neuroticism is confirmed in the individual and the entry and exit conditions are met, the study will be entered. Citalopram will be taken at a dose of 20 mg per day in patients and the other group will receive a placebo. Participants in the study will be blind to the intervention. The evaluation of neuroticism in the treatment and placebo group will be assess at the beginning, the second and forth weeks.
Settings and conduct
This clinical trial will be performed on 172 patients with control group, in parallel. Participants in this study will be blind to the type of intervention. The aim of this intervention is to evaluate the effect of Citalopram vs. placebo on altering the neuroticism traits. This study will be performed on residents in Ahvaz. Patient allocation will be non-random.
Participants/Inclusion and exclusion criteria
Included criteria: neuroticism traits based on NEO-60 questionnaire with a score higher than 24; age-range 24-45 years old. Excluded criteria: pregnancy; breastfeeding; psychiatric disorder based on GHQ questionnaire with a score above 23; previous history of intolerance to SSRI antidepressants; patients with a history of chronic diseases such as brain, cardiovascular, seizures and people with a history of drug abuse.
Intervention groups
This study is a randomized placebo-controlled clinical trial that will be performed on individuals in the age range of 24 to 45 years with neurotic traits above 24 for 4 weeks.
Main outcome variables
Flexibility; responsibility; psychotic; extraversion

General information

Reason for update
In the abstract part of the protocol, the method and place of the study needed to be amended. (Inpatients have been written incorrectly). The people under investigation are residents of Golestan, Razi and Imam hospitals in Ahvaz. They are not "hospitalized".
Acronym
IRCT registration information
IRCT registration number: IRCT20211208053331N1
Registration date: 2022-07-03, 1401/04/12
Registration timing: prospective

Last update: 2022-09-15, 1401/06/24
Update count: 1
Registration date
2022-07-03, 1401/04/12
Registrant information
Name
Mina Kianmanesh rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2267 3129
Email address
minakianmanesh69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Escitalopram versus placebo trial on changing the neuroticism
Public title
Evaluation of the effect of Escitalopram versus placebo trial on changing the neuroticism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neuroticism traits based on NEO-60 questionnaire with a score higher than 24 َAge-range 24-45 years old Obtaining informed consent from the individuals
Exclusion criteria:
Pregnancy or intention to conceive Lactation Presence of psychiatric disorder based on GHQ questionnaire with a score above 23 Previous history of SSRI antidepressant intolerance Patients with severe side effects of citalopram Patients with a history of chronic diseases such as brain and heart disease, vascular, seizures People with a history of drug abuse.
Age
From 24 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 172
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Subjects will be randomly divided into two groups of treatment and placebo. Citalopram S will be used in patients treated at a dose of 20 mg per day and the other group received a placebo. Participants will be blind to the treatment method and the drug used.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ahvaz University of Medical Sciences
Street address
Ahvaz Jondishapur University of Medical Sciences, Esfand ave., Golestan ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-06-22, 1400/04/01
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.063

Health conditions studied

1

Description of health condition studied
Neuroticism or neuroticism
ICD-10 code
F43.11
ICD-10 code description
Post-traumatic stress disorder, acute

Primary outcomes

1

Description
Flexibility
Timepoint
At the beginning of the study, 2 and 4 weeks after intervention
Method of measurement
Personality Inventory-Revised questionnaire

2

Description
Responsibility
Timepoint
At the beginning of the study, 2 and 4 weeks after intervention
Method of measurement
Personality Inventory-Revised questionnaire

3

Description
Psychotic
Timepoint
At the beginning of the study, 2 and 4 weeks after intervention
Method of measurement
Personality Inventory-Revised questionnaire

4

Description
Extraversion
Timepoint
At the beginning of the study, 2 and 4 weeks after intervention
Method of measurement
Personality Inventory-Revised questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Subjects aged 24-45 years with nouroticism traits above 24 will be treated with Es citalopram at a dose of 20 mg/day for 4 weeks.
Category
Treatment - Drugs

2

Description
Control group: Placebo will be performed on subjects aged 24 to 45 years with nouroticism traits above 24 for 4 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Mina Kianmanesh Rad
Street address
َGolestan Hospital, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 902 594 3609
Email
minakianmanesh69@gmail.com

2

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Mina Kianmanesh Rad
Street address
Razi Hospital, Palestine Blvd., Ahvaz,
City
Ahvaz
Province
Khouzestan
Postal code
1494161956
Phone
+98 902 594 3609
Email
minakianmanesh69@gmail.com

3

Recruitment center
Name of recruitment center
Emam Khomeyni hospital
Full name of responsible person
Mina Kianmanesh Rad
Street address
Imam Khomeyni hospital, Azadegan Street, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 902 594 3609
Email
minakianmanesh69@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Fakhri
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 902 594 3609
Email
fakhri_a@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical 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
Ahvaz University of Medical Sciences
Full name of responsible person
Shahin Norouzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 902 594 3609
Email
norouzi-s@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Kianmanesh Rad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan Hospital, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
1933655181
Phone
+98 21 2267 3129
Email
minakianmanesh69@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Kianmanesh Rad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan hospital, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135944721
Phone
+98 902 594 3609
Email
minakianmanesh69@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the article is published, the results will be available to the public.
When the data will become available and for how long
After the article is published, the results will be available to the public.
To whom data/document is available
After the article is published, the results will be available to the public.
Under which criteria data/document could be used
I have not decided yet - the release schedule is not yet known
From where data/document is obtainable
I have not decided yet - the release schedule is not yet known
What processes are involved for a request to access data/document
I have not decided yet - the release schedule is not yet known
Comments
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