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 patients hospitalized 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.
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
no 45. mehre 2 ave.fatemiyeh ave.ghaytareyeh ave .tehran
City
ahvaz
Province
Khouzestan
Postal code
1933655181
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, Razi, and Imam hospitals in Ahvaz
Full name of responsible person
mina kianmanesh rad
Street address
no 45.mehre 2 ave .fatemeye ave .gheytariye ave . tehran
City
ahvaz
Province
Khouzestan
Postal code
1933655181
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
4th floor no 143 golestan ave .mehre ave between bahman and esfand ahvaz town
City
ahvaz
Province
Khouzestan
Postal code
6135944721
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
4th floorno 143 golestan ave .mehre ave between bahman and esfand ahvaz town