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IRCT20200407046977N1 IRCT 2020-07-07 Kashan University of Medical Sciences The effect of Agomellatin with sertraline in patients with major depression Comparing the effectiveness of Agomelatine and Sertraline in the treatment of patients aged 18 to 65 years with major depression disorder 2019-12-21 anticipated 52 Complete https://irct.ir/trial/47107 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The study questinnaire was developed in 1960 by Hamilton to assess the severity of depression by a therapist. A standard, semi-structured questionnaire for assessing depression includes 24 questions and scores from 0 to 50. The questionnaire measures various aspects of depression (behavioral, physical, cognitive, emotional, emotional, hypochondriac, sexual issues, suicide, and sleep disorders). Grades 13-8 are mild depression, 18-18 are moderate depression, 19-22 are severe, and 23 and above are very severe. A score below 7 indicates no depression. This questionnaire has a satisfactory validity and very good reliability (9). In 2000, Gharaei, Houshang Mehryar and Mehrabi reported the reliability coefficient of this scale using 0.85 and 0.89 retesting methods, Randomization description: Since it was possible that the members of each group could not be equal due to probability, using the quadruple block, all the probabilities of selecting individuals in groups were considered as AABB, ABAB, BAAB, BABA, BBAA, ABBA.Each group of four patients is randomly selected from one of the above blocks and individuals are assigned to one of groups A or B, respectively (Permuted block randomization method), Blinding description: Medications are placed in similar envelopes labeled A or B so that the patient is unaware of the prescribed medication. A psychiatrist visits the patient and prescribes medication, and another psychiatrist who is unaware of the treatment assigned to the patient evaluates the treatment results with Hamilton scales. 1-2 Major depression disorder. Intervention 1: Intervention Group 1: Prescribing Agomlatin from Tadbir Kala Company with a daily dose of 25 to 50 mg for 8 weeks. Intervention 2: Control group: Sertralin tablet 50 mg/ Daily, manufactured by Abidi co. No - There is not a plan to make this available Justification or reason for not sharing IPD is Ethical considration
public Dr. Afshin Ahmadvand
Kargarnejad hospital; Kashan University of Medical Sciences; Ghotbe Ravandi bulevard
Kashan Iran (Islamic Republic of) 8715973446 +98 31 5554 9111 ahmadvand_a@kaums Kashan University of Medical Sciences scientific Dr. Afshin Ahmadvand
Kargarnejad hospital; Kashan University of Medical Sciences; Ghotbe Ravandi bulevard
Kashan Iran (Islamic Republic of) 8715973446 +98 31 5554 9111 ahmadvand_a@kaums Kashan University of Medical Sciences Iran (Islamic Republic of) Being at the age of 65-18 years old Patients with major depression based on the Hamiltonian scale and clinical interview based on the DSM5 criteria 18 years 65 years Both Pregnancy and lactation History of bipolar disorder and other psychiatric disorders Use of other antidepressants Patients with suicidal ideation Liver disease or impaired liver function test F33.9 Major depressive disorder, recurrent, unspecified Treatment - Drugs Treatment - Drugs Intervention Group 1: Prescribing Agomlatin from Tadbir Kala Company with a daily dose of 25 to 50 mg for 8 weeks. Control group: Sertralin tablet 50 mg/ Daily, manufactured by Abidi co. Depression score in the Hamilton questionnaire. Timepoint: At the beginning of the study (week 0) and weeks 2, 4, 6, and 8 after the intervention. Method of measurement: Hamilton Depression Questionnaire. Kashan University of Medical Sciences Approved 2020-03-15 Ethics Committee of Kashan University of Medical Sciences Kargarnejad Hospital; Kashan University of Medical Sciences; Ghotbe Ravandi bulevard Kashan Isfehan Iran (Islamic Republic of)