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IRCT20220706055386N1 IRCT 2022-08-13 Esfahan University of Medical Sciences The effectiveness of fluoxetine in the treatment of depression Investigating the effectiveness of fluoxetine in the treatment of major depression compared to placebo in children 4-6 years old 2022-09-06 anticipated 40 Complete https://irct.ir/trial/65120 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: As a block randomization, the patients will be divided into two groups, the first group will be treated with fluoxetine and the second group will be treated with placebo. In the randomized block method, we divide the studied subjects into blocks of 4 people, so that for the use of fluoxetine (F) or placebo (P) in each block of 4 people, there will be 6 possible situations (1. FPPF, 2. PFFP, 3. -PFPF, 4-FPFP, 5-FFPP, 6-PPFF). We create random numbers with a computer, and in case of a number between zero and one sixth, group one; If there is a number between one-sixth and two-sixths, we define two groups and in the same way the groups in 10 blocks, Blinding description: In order to avoid bias and maintain blinding, the drugs of the intervention and placebo groups are coded, and the prescribing physician of the patients, the evaluator, and the statistical consultant do not know the type of drug. The psychiatrist who visits the patient and gives the packaged and coded medication to the patient, the researcher who fills out the questionnaire, the researcher who enters the data into the software, and the epidemiologist who analyzes, blinded people in are study. N/A Major Depression. Intervention 1: Intervention group: In this group, the prescribed dose of fluoxetine will be such that the prescribed dose for each of the children is 0.7 mg per kilogram of body weight, and in the therapeutic range 5-15 mg per day as It will be syrup. Intervention 2: Control group: In this group, patients are treated with placebo in the same way as the first method, which is exactly the same as Fluoxetine drug in terms of shape, size and color, and is manufactured by the Department of Pharmaceutics, Faculty of Pharmacy, Isfahan University of Medical Sciences. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome or the like, can be shared. When: Start of access period 6 months after printing results To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: Any type of analysis on the data delivered is permitted Where to obtain: Mahdieh Soltanian How to obtain: Requests can be made by sending an email to the following address: m.soltanian1353@gmail.com Comments:
public Mahdieh Soltanian
No 45, Bahar Ave., Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 3145789674 +98 31 3786 1563 m.soltanian1353@gmail.com Esfahan University of Medical Sciences scientific Mahdieh Soltanian
Isfahan University of Medical Sciences and Health Services, Hazar Jarib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3662 6152 m.soltanian1353@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 4-6 years old The diagnosis of depression based on the DSM-V criteria related to the diagnosis of depression in preschool children for the patient must be confirmed by a psychiatrist (severity of depression will be obtained based on a high score by the subject on the revised parent anxiety-depression scale = a score higher than 25 ). No other psychiatric disorders Parents' consent to children's participation in this study No history of previous use of fluoxetine or other psychiatric drugs Not taking drugs that interfere with fluoxetine Not having separate families (single-parent children, children of divorce, having a stepmother or stepfather, or the death of parents) 4 years 6 years Both Lack of parental consent to continue studying at any time of the study Drug side effects caused by fluoxetine use F06.32 Mood disorder due to known physiological condition with major depressive-like episode Treatment - Drugs Placebo Intervention group: In this group, the prescribed dose of fluoxetine will be such that the prescribed dose for each of the children is 0.7 mg per kilogram of body weight, and in the therapeutic range 5-15 mg per day as It will be syrup. Control group: In this group, patients are treated with placebo in the same way as the first method, which is exactly the same as Fluoxetine drug in terms of shape, size and color, and is manufactured by the Department of Pharmaceutics, Faculty of Pharmacy, Isfahan University of Medical Sciences. Major Depression. Timepoint: Measurement of major depression at the beginning of the study (before the start of the intervention) and the fourth week and three months after starting the fluoxetine drug. Method of measurement: The Revised Child Anxiety and Depression Scales–Parent Version (RCADS-P). Esfahan University of Medical Sciences Approved 2022-06-28 Ethics Committees of Isfahan University of Medical Sciences Ethics Committee, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)