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IRCT20190525043700N5 IRCT 2022-12-29 Babol University of Medical Sciences Treatment of depressive symptoms in patients with heart failure Comparison of the effectiveness of Escitalopram and Bupropion in treatment of depression symptome patient with heart failure in double blind randomized clinical trial 2023-01-20 anticipated 80 Complete https://irct.ir/trial/67672 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to two groups of 40 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: Bupropion (Zibutrin) (Tehran Daro Pharmaceutical Group) and Citalopram (Takajeh Pharmaceutical Group) in completely similar containers without name labels, which are prepared and coded in the same color and smell, and are provided to the researcher based on random allocation by the project statistics expert. Takes. Therefore, none of the patients and the researcher will know about the assigned treatment and will not know until the end of the study. Codes are opened at the end of the study or in special cases with the diagnosis of the treating physician (in case of severe drug side effects) during the study. 3 Depression. Intervention 1: Intervention group 1: Patients in the treatment group with Bupropion (Zibutrin) (Tehran Daru Pharmaceutical Group) (75mg) start as 1 tablet daily (which can be increased up to 150mg according to the clinical response and side effects). Intervention 2: Intervention group 2: Patients in the es citalopram treatment group (Takaje drug group) (5 mg) start as 1 tablet daily (which can be increased up to a maximum of 20 mg according to the clinical response and side effects). 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 plan to release it yet.
public Romina Hamzehpour
Shahid Yahyanejad hospital, Jomhoory Eslami street
Babol Iran (Islamic Republic of) 4713566547 +98 11 3229 1951 r.hamzehpour@mubabol.ac.ir Babol University of Medical Sciences scientific Romina Hamzehpour
Shahid Yahyanejad hospital, Jomhoory Eslami street
Babol Iran (Islamic Republic of) 4713566547 +98 11 3229 1951 r.hamzehpour@mubabol.ac.ir 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 History of depression before heart failure History of seizure F32.0 Major depressive disorder, single episode, mild Treatment - Drugs Treatment - Drugs Intervention group 1: Patients in the treatment group with Bupropion (Zibutrin) (Tehran Daru Pharmaceutical Group) (75mg) start as 1 tablet daily (which can be increased up to 150mg according to the clinical response and side effects) Intervention group 2: Patients in the es citalopram treatment group (Takaje drug group) (5 mg) start as 1 tablet daily (which can be increased up to a maximum of 20 mg according to the clinical response and side effects) 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: Beck's depression inventory and Hamilton Questionnaire. Babol University of Medical Sciences Approved 2022-08-15 The Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue Babol Mazandaran Iran (Islamic Republic of)