Investigating the effect of citalopram on the prevention of agitation and delirium in intubated patients hospitalized in ICU
Design
Randomization:
Patients will be enrolled sequentially from 1 to 62. Then using a random number table, patients who get an odd number will be assigned to the intervention group and those who get an even number will be placed in the control group. This allows random allocation into the two arms.
Sample Size:
62 patients (31 in each group)
Trial Phase:
This is a Phase 2-3clinical trial.
Settings and conduct
This study is a clinical trial that will be conducted on ventilator-connected patients suffering from internal diseases and sepsis who are hospitalized in the ICU of Labafini Nejad Hospital, the patients will be included in the study as odd or even numbers. The drug group and those with an even number will be placed in the placebo group. The patients who are placed in the drug group will be gavage of escitalopram tablets daily, and the other group will be gavage of placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age greater than 18 years / acute and intubated patients admitted to the intensive care unit / patients admitted to the intensive care unit without brain injury / not currently taking any other antidepressant / not pregnant or lactating / willing to sign Informed consent form
Study exclusion criteria:
Known hypersensitivity to es-citalopram or any of its components/Active suicidal thoughts or behavior/Severe liver or kidney failure/Uncontrolled arrhythmias/ Uncontrolled bleeding
Intervention groups
intervention group :will receive 10mg of escitalopram daily. The escitalopram will be administered orally in the form of a tablet. Patients will take one 10mg tablet of escitalopram by mouth daily.
Control group: Patients randomly allocated to the control group will receive a placebo
Main outcome variables
Delirium and Agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190215042716N6
Registration date:2023-12-26, 1402/10/05
Registration timing:registered_while_recruiting
Last update:2023-12-26, 1402/10/05
Update count:0
Registration date
2023-12-26, 1402/10/05
Registrant information
Name
navid shafigh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 3378
Email address
n.shafigh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-03, 1402/09/12
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of citalopram in the prevention of delirium in intubated patients without brain damage in Labafinejad Hospital ICU
Public title
A comparative study of the effect of citalopram in the prevention of delirium in intubated patients without brain damage in Labafinejad Hospital ICU
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age》18 years old
Acute patients hospitalized in the intensive care unit (ICU under mechanical ventilation with a ventilator)
Patients hospitalized in the intensive care unit without brain damage
Is not currently taking any other antidepressants
Not pregnant or lactating
Willing to sign an informed consent form
Exclusion criteria:
Known hypersensitivity to es-citalopram or any of its components
Active suicidal thoughts or behavior
Severe liver or kidney failure
Uncontrolled arrhythmias
Active bleeding History of mania or hypomania
Severe personality disorders
Current substance abuse or dependence
Participation in other clinical trials
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be included in the study as even or odd numbers. That is, from numbers 1 to 62, all the people with odd numbers will be in the drug group and those with even numbers will be in the placebo group. We will enroll patients into the study sequentially and assign them numbers from 1 to 62 based on order of enrollment.
Patients with odd numbers (1, 3, 5, etc.) will be placed in the treatment group. This group will receive 10mg of escitalopram daily via oral administration.
Patients with even numbers (2, 4, 6, etc.) will be placed in the placebo group. This group will also receive an oral administration but will not receive the active drug.
At the end of the study, we will compare the treatment effect between the two groups.
This method allows for random allocation of patients into the two groups. The patients who are in the drug group will be given daily Citalopram 10 mg tablet will be gavage and will be gavage in the placebo group
Blinding (investigator's opinion)
Double blinded
Blinding description
The nurses will give the drugs of the 2 groups, which are completely matched in terms of shape, color and packaging, to the patients, and after that, the special care nurse, who has no knowledge of the received medicine, will collect the requested parameters of the patients, and then The information in two groups will be given to the data analyst and will be analyzed
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University od Medical Sciences
Street address
Faculty of Medicine - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2023-12-03, 1402/09/12
Ethics committee reference number
IR.SBMU.MSP.REC.1402.483
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
2
Description of health condition studied
Agitation
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Agitation
Timepoint
3 hours after gavage of citalopram and placebo to intubated patients hospitalized in ICU for 14 days
Method of measurement
Richmond agitation sedation scale
2
Description
Delirium
Timepoint
3 hours after gavage of citalopram and placebo to intubated patients hospitalized in ICU for 14 days
Method of measurement
CAM_ICU score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients randomly allocated to the intervention group will receive 10mg of escitalopram daily. The escitalopram will be administered orally in the form of a tablet. Patients will take one 10mg tablet of escitalopram by mouth once daily. This group is the active treatment group receiving the study medication escitalopram.Escitalopram is a selective serotonin reuptake inhibitor (SSRI) used to treat major depressive disorder and generalized anxiety disorder. It works by blocking the reabsorption of serotonin in the brain, which increases the level of serotonin available to improve mood and emotional state.The 10mg daily dose of escitalopram was selected as it is a common starting dose for this medication. Patients in the intervention group will come in to the study clinic once a day and be directly observed taking their 10mg dose of escitalopram tablets to ensure adherence. They will then be assessed for efficacy and side effects throughout the trial duration.
Category
Treatment - Drugs
2
Description
Control group: Patients randomly allocated to the control group will receive a placebo. The placebo will be in the form of a tablet similar to the escitalopram tablets but without any active ingredients. Similar to the intervention group, patients in the control group will also receive one oral tablet daily under direct observation. However, since the placebo contains no active drug, they do not actually receive an active treatment. Comparing this group to the intervention group will demonstrate the treatment effect of escitalopram.