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IRCT20190525043700N4 IRCT 2021-10-25 Babol University of Medical Sciences Efficacy of three drugs agomelatine, bupropion and sertraline in the treatment of major depressive disorder Comparison of the effectiveness of three drugs agomelatine, bupropion and sertraline in the treatment of non psychotic major depressive disorder: A randomized double blind clinical trial 2021-10-23 anticipated 90 Complete https://irct.ir/trial/59346 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to three groups of 30 using 6 blocks in a ratio of 1: 1: 1. Randomization will be performed using a randomization table (computer randomization program). The randomization table will be created by a statistical expert and will be provided to the researchers. The patient and the researcher (evaluator) will not know how to classify and the type of drug received and only the treating physician is aware of the type of drug, Blinding description: Agomelatine (Tadbir Kalay Jam Company), Sertraline (Sobhan Company) and Bupropion (Obaidi Company) will be poured into separate capsules in the form of crushed tablets. The shape, color, size and packaging of all medicines are exactly the same.Consecutive opaque numbered envelopes were used to conceal the allocation. 3 Major depressive disorder. Intervention 1: Intervention group1:Patients in the agomelatine group (Tadbir Kalay Jam Company) will initially receive 25 mg of the drug daily at bedtime for two weeks, and patients who do not show improvement with 25 mg per day will be increased to 50 mg per day. (Depending on the patient's response, it is possible to increase the dose to a maximum of 50 mg). Intervention 2: Intervention group2: Patients in the sertraline group (Sobhan company) will receive 50 mg of the drug every morning (depending on the patient's response, the dose can be increased to a maximum of 200 mg). Intervention 3: Intervention group3: Patients in the bupropion group (Abidi company) will receive 75 mg twice a day (depending on the patient's response, the dose can be increased to a maximum of 450 mg). No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Romina Hamzehpour
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 4713566547 +98 11 3219 9595 r.hamzehpour@mubabol.ac.ir Babol University of Medical Sciences scientific Romina Hamzehpour
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 4713566547 +98 11 3219 9595 r.hamzehpour@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Age 20-60 years Major Depressive Disorder (Based on the diagnosis of a psychiatrist and a psychiatric assistant with a structured clinical interview based on the DSM-5) 20 years 60 years Both Drug abuse Hypothyroidism Severe anemia Pregnancy and lactation Epilepsy Mental retardation F32.0 Major depressive disorder, single episode, mild Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1:Patients in the agomelatine group (Tadbir Kalay Jam Company) will initially receive 25 mg of the drug daily at bedtime for two weeks, and patients who do not show improvement with 25 mg per day will be increased to 50 mg per day. (Depending on the patient's response, it is possible to increase the dose to a maximum of 50 mg). Intervention group2: Patients in the sertraline group (Sobhan company) will receive 50 mg of the drug every morning (depending on the patient's response, the dose can be increased to a maximum of 200 mg). Intervention group3: Patients in the bupropion group (Abidi company) will receive 75 mg twice a day (depending on the patient's response, the dose can be increased to a maximum of 450 mg). Patient´s depressive condition. Timepoint: Before the intervention (first visit), end of the second week (second visit), end of the fourth week (third visit), end of the eighth week (fourth visit). Method of measurement: Hamilton Questionnaire. Babol University of Medical Sciences Approved 2021-10-06 The Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue Babol Mazandaran Iran (Islamic Republic of)