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IRCT20090117001556N147 IRCT 2022-09-13 Tehran University of Medical Sciences Efficacy of citalopram and sertraline in depression according to BDNF, IL-6, and cortisol levels Evaluating the effectiveness of citalopram and sertraline in the treatment of depression with respect to the level of BDNF, IL-6, and cortisol in men and women with major depressive disorder: A randomized double-blinded clinical trial 2022-11-22 anticipated 80 Complete https://irct.ir/trial/65872 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups), Blinding description: The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process. 2-3 Depression. Intervention 1: Control group: Men and women with major depressive disorder receiving citalopram (40 mg daily) for six weeks. Intervention 2: Intervention group: Men and women with major depressive disorder receiving sertraline (100 mg/day) for six weeks. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2023 to 2028 To whom: Academic researchers Conditions: Users should cite the resource of data Where to obtain: Prof. Shahin Akhondzadeh How to obtain: By E-mail Comments:
public Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18-60 years old Based on DSM-V have a diagnosis of major depression (MDD) and their minimum severity of depression based on HDRS is 19 18 years 60 years Both Any other mental disorder in another axis Serious suicidal thoughts (<2 in suicidal HDRS section) Psychosis History of ECT in recent two months History of mania and hypomania Thyroid dysfunctions History of cardiovascular disease Diabetes Autoimmune disorders Presence of active infection Neurologic disorders like epilepsy and Alzheimer's disease Liver disease Kidney disease Pregnant or lactating women F32.1 Major depressive disorder, single episode, moderate Treatment - Drugs Treatment - Drugs Control group: Men and women with major depressive disorder receiving citalopram (40 mg daily) for six weeks. Intervention group: Men and women with major depressive disorder receiving sertraline (100 mg/day) for six weeks. Severity of depression. Timepoint: Weeks 0 , 4 , 8. Method of measurement: By Hamilton Depression Rating Scale. Tehran University of Medical Sciences Approved 2022-06-17 Ethics Committee of School of Medicine, Tehran University of Medical Sciences Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)