The study of of Escitalopram ̓s effectiveness on treatment of mild to moderate depressive disorder and improvement of quality of life in patients who are undergone coronary artery bypass graft surgery (CABG) – A randomized double blind placebo controlled trial

The study of Escitalopram ̓s effectiveness on treatment of mild to moderate depressive disorder and improvement of quality of life in patients who are undergone coronary artery bypass graft surgery

Clinical trial with control group, double-blind, randomized on 50 patients. Randomization using the software

Patients who are undergoing Coronary Artery Bypass Graft surgery in Tehran Heart Center hospital are evaluated with Beck Depression Inventory and Quality of Life questionnaire (Short Form-36 ) and their demographic characteristics will be registered. BDI scores from 10 to 20 are Confirmed through clinical interview by a psychiatrist. patients are randomly divided into intervention group and control group.The study is blinded from the patients and the researcher. Both groups are treated for 8 weeks. During the second week and the fourth week of the treatment , patients are visited in the clinic in order to investigate side effects of drug. Questionnaires will be completed in the fourth week and the end of treatment (week 8)

inclution critria: coronary artery bypass graft surgery ,Age (18-75), Beck Depression Inventory score (10-20), exclusion critria: Previous history of intolerance to SSRI ,Psychosis or dementia or mental retardation disorder ,Severe liver disease,High risk of postoperative cardiac complications such as bleeding, participating in other trials, History of Bipolar Disorder, Patients who have been treated with escitalopram or an antidepressant during the previous month, Recent alcohol and substances abuse,Pregnancy and lactation

intervention group: tablet escitalopram 10 mg (Selective Serotonin Reuptake Inhibitors) and control group : tablet placebo , both drugs produced by Abidi company ,once a day ,one tablet, for 8 weeks

Depression؛ Quality of life

Edit study execution time and sample size

Randomization method: Simple randomization using a computer randomization method, in this method we randomly place each client in the intervention or control group. Randomization unit: individual, Randomization tool and randomization sequence: determined by excel software and RAND Function. allocation concealment: The type of treatment allocated in the two groups is completely unpredictable. Assignment to groups is also hidden from the researcher and patients by coding the drug and placebo group.

This clinical trial is blinded so that the participants, the clinician, , principle researcher,data collector and outcome evaluator do not have any info about the assignment of individuals to the groups. The evaluation of the subjects is done by the external evaluator who is not involved in the research team. The main drug and placebo that are similar (in terms of odour, color, shape and taste) are placed in similar cans having the same weight by a person who is not a member of the research team. Drugs are coded based on random sequence in two groups ( A) and (B) and they are numbred randomly. A unique code is assigned to each patient .The researcher provides the drug to the participant according to the coding.