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IRCT20140126016374N2 IRCT 2020-11-22 University of social welfare and rehabilitation sciences Escitalopram ̓s effectiveness on treatment of depressive disorder and improvement of quality of life in patients who are undergone coronary artery bypass graft surgery 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 2020-11-21 anticipated 50 Complete https://irct.ir/trial/49571 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Depression Disorder. Intervention 1: Intervention group: take escitalopram 10 mg؛ once daily ؛ oral ؛ pruduct by Abidi company ؛For 8 weeks. Intervention 2: Control group: take placebo tablet ؛ Produced by Abaidi Company؛ once daily ؛ Oral ؛ For 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Fatemeh Asadian Kuhestani
Razi psychiatric Hospital ، shahre Rey، Tehran
Tehran Iran (Islamic Republic of) 1313913139 +98 21 3340 1604 f.asadian1392@gmail.com University of social welfare and rehabilitation sciences scientific Dr. Mohammad Reza khodaie Ardakani
Razi psychiatric Hospital ، Shahre Rey، Tehran
Tehran Iran (Islamic Republic of) 1313913139 +98 21 3340 1604 kh.ardakani@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) coronary artery bypass graft surgery Age >18 (18-75) patient with beck depression inventory score 10-20 18 years 75 years Both Previous history of intolerance to serotonin reuptake inhibitor antidepressants Psychosis or dementia or mental retardation disorder in the patient Severe liver disease High risk of postoperative cardiac complications such as bleeding Patients participating in other trials History of bipolar disorder Patients who have been treated with escitalopram or an antidepressant during the previous month Recent abuse of alcohol and substances Pregnancy and lactation F32.8 Other depressive episodes Treatment - Drugs Treatment - Drugs Intervention group: take escitalopram 10 mg؛ once daily ؛ oral ؛ pruduct by Abidi company ؛For 8 weeks Control group: take placebo tablet ؛ Produced by Abaidi Company؛ once daily ؛ Oral ؛ For 8 weeks Degree of Depression. Timepoint: Beginning of the study (before the intervention)؛ Week 4؛ Week 8 (after treatment)؛. Method of measurement: Beck Depression Inventory (BDI-II). Quality of life. Timepoint: Beginning of the study (before the intervention)؛ Week 4 ؛ Week 8 (after treatment)؛. Method of measurement: Quality of Life questionnaire ، 36-Item Short Form (SF-36). Drug complication. Timepoint: 2 and 4 weeks after taking the drug. Method of measurement: Checklist of drug side effects. University of social welfare and rehabilitation sciences Approved 2020-09-18 Ethis committee of University of Social Welfare & Rehabilitation sciences University of Social Welfare & Rehabilitation Sciences، Koodakyar street، Velenjac Tehran Tehran Iran (Islamic Republic of)