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IRCT20170108031818N5 IRCT 2023-06-13 Gorgan University of Medical Sciences The effect of adding pregabalin to fluoxetine in the treatment of children with anxiety disorders Investigating the effect of adding pregabalin to fluoxetine in the Treatment of children aged 9 To 14 years with anxiety disorders referred To a child and adolescent psychiatric clinic 2023-09-21 anticipated 60 Complete https://irct.ir/trial/70593 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, after informed consent was obtained from the parents of eligible children, the participants were divided into two groups A (receivers of fluoxetine and pregabalin main treatment) and B (fluoxetine and placebo) by random block method. They will be. In this way, first, the size of the blocks is considered to be four. Therefore, according to the treatment groups, 6 different combinations are created. Therefore, in the form of randomly placed sampling, 15 blocks are selected based on the table of random numbers obtained by the computer program, and based on that, the samples included in the study will be entered into different groups. This will continue until we reach a sufficient number of samples in each group. For example, if block number 1 is selected in the first selection, it means that the first two samples will enter group A, and the third and fourth samples will enter group B, and the block will be selected again for the next 4 samples. B B A A ۱ B A B A ۲ A B B A ۳ A A B B ۴ A B A B ۵ B A A B ۶, Blinding description: The study is double-blind, the patient and the examining psychiatric assistant will not know the type of treatment. 3 Anxiety disorder. Intervention 1: Intervention group:For 2 months, in addition to their main treatment (fluoxetine syrup in the first week with a dose of 2.5 cc daily and a dose of 5 cc daily from the second week), they will receive daily pregabalin with a dose of 2.5 mg/kg for 8 weeks. Intervention 2: Control group: In addition to their main treatment (fluoxetine syrup with the same dose and the same duration), they will receive a placebo drug that looks and tastes the same as pregabalin capsules. 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 firoozeh derakhshanpoor
Shast kola St, Golestan University of Medical Sciences
Gorgan Iran (Islamic Republic of) 455435552 0173215846 dr.derakhshanpoor@gmail.com Gorgan University of Medical Sciences scientific firoozeh derakhshanpoor
Shast kola St, Golestan University of Medical Sciences
Gorgan Iran (Islamic Republic of) 4652865253 +98 17 3566 5254 dr.derakhshanpoor@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Age 9-14 years Children with anxiety disorders based on psychiatrist diagnosis and DSM-5 criteria New case 9 years 14 years Both Having accompanying mood disorder - psychotic disorder - pervasive developmental disorder Receive any type of psychotherapy Taking psychiatric medications other than SSRIs History of complications and drug sensitivity History of seizures Lack of consent of the patient or legal guardian during the plan Mental and physical retardation In case of any concomitant medical disorder such as IP, autism, epilepsy Having physical diseases such as liver disease, heart disease, kidney disease F06.4 Anxiety disorder due to known physiological condition Treatment - Drugs Treatment - Drugs Intervention group:For 2 months, in addition to their main treatment (fluoxetine syrup in the first week with a dose of 2.5 cc daily and a dose of 5 cc daily from the second week), they will receive daily pregabalin with a dose of 2.5 mg/kg for 8 weeks. Control group: In addition to their main treatment (fluoxetine syrup with the same dose and the same duration), they will receive a placebo drug that looks and tastes the same as pregabalin capsules. Anxiety disorder score. Timepoint: Beginning of the study and 8 weeks after the start of the intervention. Method of measurement: Anxiety questionnaire for children and adolescents (YAM-5). Anxiety severity based on CGAS. Timepoint: Beginning of the study and 8 weeks after the start of the intervention. Method of measurement: Children Global Assessment Scale. Gorgan University of Medical Sciences Approved 2023-04-25 Ethics committee of Golestan University of Medical Sciences Shast kola St, Golestan University of Medical Sciences Gorgan Golestan Iran (Islamic Republic of)