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IRCT20170606034348N7 IRCT 2022-12-26 Babol University of Medical Sciences Treatment of depressive symptoms in patients with heart failure The comparison of the efficacy of Agomelatine and Sertraline in treatment of depression symptoms in patients with heart failure in double-blind randomized clinical trial 2023-01-20 anticipated 58 Complete https://irct.ir/trial/67598 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to two groups of 29 people using blocks of 4 and a ratio of 1:1. Randomization will be done using Statistics and Sample Size android software. In order to hide the treatment process, each drug is assigned a random code corresponding to the sequence generated above, and only the random code is written on the cans of the drugs. After entering the patients into the study and assigning treatment to them, the code inserted on the medicine will be recorded on the patient's file, Blinding description: Agomelatine (Tekaje Company) and Sertraline (Soban Company) are prepared and coded in identical containers without name labels, and are provided to the researcher based on random allocation by the design statistician. Therefore, none of the patients and the researcher will know about the assigned treatment and will not know until the end of the study. The opening of the codes is done at the end of the study or in special cases with the diagnosis of the treating doctor (in case of severe drug side effects) during the study. 3 Depression. Intervention 1: Intervention group 1: Sertraline group patients (Soban company) will receive one 50 mg tablet daily (depending on the patient's response, it is possible to increase the dose up to a maximum of 200 mg). Intervention 2: Intervention group 2: Patients in the agomelatine group (Tekaje company) will receive one 25 mg tablet daily (depending on the patient's response, it is possible to increase the dose up to a maximum of 50 mg). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no plan to release it yet.
public Dr. Angela Hamidia
Shahid Yahyanejad hospital, Jomhoory Eslami street
Babol Iran (Islamic Republic of) 4713566547 +98 11 3229 1951 angela_7633@yahoo.com Babol University of Medical Sciences scientific Dr. Angela Hamidia
Shahid Yahyanejad hospital, Jomhoory Eslami street
Babol Iran (Islamic Republic of) 4713566547 +98 11 3229 1951 angela_7633@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Age over 18 years old With heart failure Depressive Disorder (Based on the questionnaire) Willingness to participate in the study 18 years no limit Both Patient with cognitive impairment Mental retardation History of substance use Bipolar disorder Kidney/Liver failure Any uncontrolled medical illness F32.0 Major depressive disorder, single episode, mild Treatment - Drugs Treatment - Drugs Intervention group 1: Sertraline group patients (Soban company) will receive one 50 mg tablet daily (depending on the patient's response, it is possible to increase the dose up to a maximum of 200 mg). Intervention group 2: Patients in the agomelatine group (Tekaje company) will receive one 25 mg tablet daily (depending on the patient's response, it is possible to increase the dose up to a maximum of 50 mg). Patient´s depressive condition. Timepoint: Before intervention (first visit) ,the end of the fourth week (second visit), the end of the eighth week (third visit), the end of the twelfth week (the fourth visit). Method of measurement: BDI and Hamilton Questionnaire. Babol University of Medical Sciences Approved 2022-12-14 The Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue Babol Mazandaran Iran (Islamic Republic of)