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IRCT20230510058142N1 IRCT 2023-12-09 Shahid Beheshti University of Medical Sciences The effect of treatment with escitalopram on quality of life and hospitalization rate in depressed patients with systolic heart failure The effect of treatment with escitalopram on quality of life and hospitalization rate in depressed patients with systolic heart failure: a double blind randomized controlled trial 2023-05-22 anticipated 84 Complete https://irct.ir/trial/70116 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: All eligible people will be randomly assigned to one of the two groups to receive medicine or placebo with a ratio of 1:1. Randomization will be done automatically by creating random numbers in an Excel file and assigning people to two drug and placebo groups.The rand function of Excel software was used for randomization, Blinding description: This study is double-blind. The medicine and placebo needed for the people participating in the study will be completely covered and indistinguishable form for use by patients. The people participating in the study and the evaluators of the final outcome of the patients will not be aware of the drug or placebo. The grouping of patients will be done based on the allocation of random numbers in the Excel file prepared by the researcher responsible for the study, and other people and patients will not know about the grouping. 3 heart failure. Intervention 1: Intervention group: Taking 20 mg of es citalopram orally, manufactured by abidi company, for 8 weeks from the beginning of the study then Refer to a psychiatrist after the end of the study to continue antidepressant treatment. Intervention 2: Control group: Taking placebo for 8 weeks, referring patients to a psychiatrist after the end of the intervention to start anti-depressant treatment. 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 further information
public farnaz pourrajab
Shahid Madani Ave, Imam Hossein hospital, Tehran
Tehran Iran (Islamic Republic of) 6314116177 +98 21 7343 3000 farnazpourrajab71@gmail.com Shahid Beheshti University of Medical Sciences scientific farnaz pourrajab
Shahid Madani Ave, Imam Hossein hospital,Tehran
Tehran Iran (Islamic Republic of) 6314116177 +98 21 7343 3000 farnazpourrajab71@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People aged 30 to 75 years Patients with left ventricular systolic dysfunction (left ventricular ejection fraction <0.40) Clinical diagnosis of heart failure with at least one episode of dyspnea either with minimal activity or at rest NYHA classIII or IV Informed consent of patients 30 years 75 years Both Previous history of intolerance to SSRI antidepressants Bipolar or severe personality disorder Severe suicidal thoughts Recent dependence on alcohol or drugs pregnancy breastfeeding I50 Heart failure Treatment - Drugs Placebo Intervention group: Taking 20 mg of es citalopram orally, manufactured by abidi company, for 8 weeks from the beginning of the study then Refer to a psychiatrist after the end of the study to continue antidepressant treatment Control group: Taking placebo for 8 weeks, referring patients to a psychiatrist after the end of the intervention to start anti-depressant treatment Quality of life. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Minnesota Standard Questionnaire. Hospitalization rate. Timepoint: The beginning of the study and 2 month later. Method of measurement: Patient files and Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2023-05-02 Ethics committee of Shahid beheshti University of Medical Sciences Zarafshan Ave, Qods Town,Tehran Tehran Tehran Iran (Islamic Republic of)