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IRCT20230803059021N1 IRCT 2023-08-10 Esfahan University of Medical Sciences topiramate treatment with haloperidol in chronic tic disorder Comparing the effectiveness of topiramate treatment with haloperidol in chronic tic disorder 2023-08-23 anticipated 32 Complete https://irct.ir/trial/71844 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, with the help of a random number table, a number of random numbers were generated according to the sample size, and then they were placed in sealed envelopes in this order and numbered on the envelopes. Then, according to the order in which the participants entered the study, an envelope is opened and a random sequence is determined. 2-3 chronic tic disorder. Intervention 1: Intervention group: Treatment with haloperidol manufactured by Subhan Daru company in the form of 0.25 to 8 mg daily for 2 months. Intervention 2: Intervention group: Treatment with topiramate drug manufactured by Elixir Danesh company in the form of 50 to 200 mg daily for 2 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Faime Rezaie
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8974673461 +98 31 3668 8138 rezaeedr022@gmail.com Esfahan University of Medical Sciences scientific Fahime Rezaie
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8974673461 +98 31 3668 8138 rezaeedr022@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) parental informed consent DSM-V criteria for chronic tic disorder age between 6 and 12 6 years 12 years Both Presence of major medical disorders such as epilepsy, diabetes, heart and kidney diseases mental retardation Hypersensitivity to topiramate and haloperidol The presence of concomitant psychiatric disorders that require drug intervention History of long QT syndrome, cardiac arrhythmia, kidney stones and concurrent use of carbonic anhydrase inhibitor drugs F95.1 Chronic motor or vocal tic disorder Treatment - Drugs Treatment - Drugs Intervention group: Treatment with haloperidol manufactured by Subhan Daru company in the form of 0.25 to 8 mg daily for 2 months Intervention group: Treatment with topiramate drug manufactured by Elixir Danesh company in the form of 50 to 200 mg daily for 2 months Tic. Timepoint: before treatment and 1 month after and 2 month after. Method of measurement: Yale Global Tic Severity scale. Esfahan University of Medical Sciences Approved 2023-04-29 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)