This study aims to evaluate the efficacy of citalopram in depression and quality of life of patients with acute coronary syndrome ( included acute myocardial infarction or unstable angina). Study population includes 40 patients with acute coronary syndrome in the age more than 18 years who are admitted in two cardiac care units affiliated to Babol University of Medical Sciences. Psychological tests will be asked when the patients have stable cardiac status and are ready to answer to the questions. At first, the patients will be assessed with Hospital Anxiety and Depression Scale and the patients whose scores are more than 11 will be included in the study. Then, their quality of life will be assessed with a questionnaire. These patients will be allocated randomly in intervention and control groups. 20 patients in intervention group will receive 20 milligram citalopram in a day for 8 weeks and 20 persons in the control group will be followed for 8 weeks without this drug. In the third and eighth weeks after intervention, Hospital Anxiety and Depression Scale and patients quality of life will be assessed repeatedly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091722991N6
Registration date:2016-09-30, 1395/07/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-30, 1395/07/09
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of citalopram in depression and quality of life in patients with acute coronary syndrome
Public title
The efficacy of citalopram in depression and quality of life in the patients with cardiac disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: admission in cardiac care units because of acute coronary syndrome; age more than 18 years; women in reproductive ages who are not pregnant and do not want to have pregnancy in duration of the study; assignment the informed consent form of the study
Exclusion criteria: past history of intolerance to selective serotonin reuptake inhibitors; severe and life threatening medical conditions which inhibit the participation of the patient in duration of the study; severe congestive heart failure with diagnosis of the cardiologist; dependence to alcohol or other addictive drugs; psychosis or dementia or mental retardation in patient; pregnancy and breast feeding; history of elevated mood
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
University of Medical Sciences, Babol
City
Babol
Postal code
Approval date
2015-03-11, 1393/12/20
Ethics committee reference number
Mubabol.Rec.1393.2
Health conditions studied
1
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
120.0
ICD-10 code description
Unstable Angina
2
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
121
ICD-10 code description
Acute Myocardial Infarction
Primary outcomes
1
Description
patient´s depressive condition
Timepoint
3th and 8th weeks after treatment
Method of measurement
Hospital Anxiety and Depression Scale
2
Description
patient´s quality of life
Timepoint
3th and 8th weeks after treatment
Method of measurement
SF-36 Quality of Life Questionnaire
Secondary outcomes
1
Description
adverse drug reaction
Timepoint
3rd and 8th weeks after treatment
Method of measurement
psychiatric visit
Intervention groups
1
Description
Intervention group: Ramopharmin drug company citalopram tablets 20 milligram daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: weekly psychiatric visit without any antidepressant drug for 8 weeks