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IRCT20230619058530N1 IRCT 2023-07-20 Esfahan University of Medical Sciences effects of folic acid combination with fluoxetine in treatment of patients with major depressive disorder under age 18 randomized controlled trial folic acid combination with fluoxetine in treatment of patients with major depressive disorder under age 18 2023-07-23 anticipated 40 Complete https://irct.ir/trial/70809 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: in ordering of entrance time, each sample will give specific code between 1-40 and then, using online computer randomization(random.org) will be randomized in intervention or placebo group with a simple randomization manner by a 1:1 ratio, Blinding description: Participants in both intervention and control group will be blinded about drug or placebo with similarity in shape of drug and placebo. principle investigator will be blinded with random placing the participants in both control and intervention group so give each participant a numerical code. health care providers offer the drug and placebo base on A and B codes to participants and data collectors and outcome assessors will be blinded because they will collect data and assess them without any information about drug or placebo type. 3 major depressive disorder. Intervention 1: Intervention group: folic acid tablet (Folic acid-IRAN DAROO 1MG TAB) with dose 1-5mg daily, once daily orally for 3 month. Intervention 2: Control group: placebo tablet(School of Pharmacy and Pharmaceutical SciencesSchool of Isfahan University of Medical Sciences) contains starch and calcium diphosphate with dose 1-5 tablet per day orally and once daily. 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 further information
public Mostafa Haghshenas
Hezar Jerib Street
isfahan Iran (Islamic Republic of) 8174673461 +98 31 3222 2475 haghshenas2005@gmail.com Esfahan University of Medical Sciences scientific Mostafa Haghshenas
Hezar jerib street
isfahan Iran (Islamic Republic of) 8174673461 +98 31 3222 2475 haghshenas2005@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) clinical diagnosis of Major Depressive Disorder according to DSM-5 criteria consent to participate in the study by completing the informed consent form by patient and patient Lack of any history of receiving any anti depressant drug or mood stabilizers during recent 3 month before study lack of history of allergic reaction to drug age between 6-18 years 6 years 18 years Both need to ECT treatment during study any unexpected new physical or mental condition that could change medical care of patient F32 Major depressive disorder, single episode Treatment - Drugs Placebo Intervention group: folic acid tablet (Folic acid-IRAN DAROO 1MG TAB) with dose 1-5mg daily, once daily orally for 3 month Control group: placebo tablet(School of Pharmacy and Pharmaceutical SciencesSchool of Isfahan University of Medical Sciences) contains starch and calcium diphosphate with dose 1-5 tablet per day orally and once daily Major depressive disorder. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Children Depression Inventory (CDI). Blood indices(red blood cells, hemoglobin and men corpuscular volume(. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit. Esfahan University of Medical Sciences Approved 2023-07-17 Research Ethics Committees of Research Ethics Committee of the "Alzahra Research Centers" Hezar-Jerib street esfahan Isfehan Iran (Islamic Republic of)