Protocol summary
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Study aim
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Evaluation of the effect of Escitalopram versus placebo on changing the neuroticism
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Flexibility; responsibility; psychotic; extraversion
General information
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Reason for update
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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".
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Acronym
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IRCT registration information
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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
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Registration date
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2022-07-03, 1401/04/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-07-23, 1401/05/01
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Expected recruitment end date
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2022-09-06, 1401/06/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effect of Escitalopram versus placebo trial on changing the neuroticism
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Public title
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Evaluation of the effect of Escitalopram versus placebo trial on changing the neuroticism
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 24 years old to 45 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
172
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-22, 1400/04/01
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Ethics committee reference number
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IR.AJUMS.HGOLESTAN.REC.1400.063
Health conditions studied
1
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Description of health condition studied
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Neuroticism or neuroticism
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ICD-10 code
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F43.11
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ICD-10 code description
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Post-traumatic stress disorder, acute
Primary outcomes
1
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Description
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Flexibility
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Timepoint
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At the beginning of the study, 2 and 4 weeks after intervention
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Method of measurement
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Personality Inventory-Revised questionnaire
2
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Description
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Responsibility
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Timepoint
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At the beginning of the study, 2 and 4 weeks after intervention
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Method of measurement
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Personality Inventory-Revised questionnaire
3
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Description
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Psychotic
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Timepoint
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At the beginning of the study, 2 and 4 weeks after intervention
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Method of measurement
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Personality Inventory-Revised questionnaire
4
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Description
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Extraversion
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Timepoint
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At the beginning of the study, 2 and 4 weeks after intervention
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Method of measurement
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Personality Inventory-Revised questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo will be performed on subjects aged 24 to 45 years with nouroticism traits above 24 for 4 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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After the article is published, the results will be available to the public.
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When the data will become available and for how long
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After the article is published, the results will be available to the public.
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To whom data/document is available
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After the article is published, the results will be available to the public.
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Under which criteria data/document could be used
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I have not decided yet - the release schedule is not yet known
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From where data/document is obtainable
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I have not decided yet - the release schedule is not yet known
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What processes are involved for a request to access data/document
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I have not decided yet - the release schedule is not yet known
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Comments
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