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IRCT20090117001556N151 IRCT 2023-06-19 Tehran University of Medical Sciences The efficacy of Ropinirole in the improvement of ADHD Ropinirole as an adjuvant therapy with methylphenidate in the treatment of ADHD in children: A randomized, double-blind, placebo-controlled clinical trial 2023-07-23 anticipated 50 Complete https://irct.ir/trial/70736 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: 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 ADHD. Intervention 1: Control group: Ritalin, 0.1-3.5 mg per kg of body weight. For the first week, one tablet daily (1.2 tablets at the morning, 1.2 tablets at the noon), and for the second week, one tablet at the morning and one tablet at the noon. If the patient's weight is over 30 kg, three pills are prescribed daily, 1 at the morning, 1 at the noon, and 1 at the afternoon (4 p.m.), from the third week. Placebo is prescribed twice a day. Total duration of treatment is 8 weeks. Intervention 2: Intervention group: Ritalin, 0.1-3.5 mg per kg of body weight. For the first week, one tablet daily (1.2 tablets at the morning, 1.2 tablets at the noon), and for the second week, one tablet at the morning and one tablet at the noon. If the patient's weight is over 30 kg, three pills are prescribed daily, 1 at the morning, 1 at the noon, and 1 at the afternoon (4 p.m.), from the third week. Ropinirole is prescribed at a dose of 0.25 mg twice a day. Total duration of treatment is 8 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) ADHD diagnosis based on DSM5 Children between 6-17 years old. 6 years 17 years Both Presence of severe medical illness, neurological problems and problems requiring surgery Presence of any concomitant psychiatric disorder that requires treatment with psychiatric drugs except ODD History of treatment with ropinirole in the three months prior to the study Consumption neuroleptic medication in the last 6 months Weight less than 13.5 kg Mental retardation Uncontrolled seizure disorder Systolic blood pressure above 125 mm Hg or Resting pulse rate less than 60 beats per minute or above 115 beats per minute Using any medicine or supplement for the treatment of ADHD History of allergy to methylphenidate or ropinirole F90.2 Attention-deficit hyperactivity disorder, combined type Placebo Treatment - Drugs Control group: Ritalin, 0.1-3.5 mg per kg of body weight. For the first week, one tablet daily (1.2 tablets at the morning, 1.2 tablets at the noon), and for the second week, one tablet at the morning and one tablet at the noon. If the patient's weight is over 30 kg, three pills are prescribed daily, 1 at the morning, 1 at the noon, and 1 at the afternoon (4 p.m.), from the third week. Placebo is prescribed twice a day. Total duration of treatment is 8 weeks. Intervention group: Ritalin, 0.1-3.5 mg per kg of body weight. For the first week, one tablet daily (1.2 tablets at the morning, 1.2 tablets at the noon), and for the second week, one tablet at the morning and one tablet at the noon. If the patient's weight is over 30 kg, three pills are prescribed daily, 1 at the morning, 1 at the noon, and 1 at the afternoon (4 p.m.), from the third week. Ropinirole is prescribed at a dose of 0.25 mg twice a day. Total duration of treatment is 8 weeks. Severity of ADHD. Timepoint: Weeks: 0 , 4 , 8. Method of measurement: By ADHD Rating Scale (by parents or teacher). Tehran University of Medical Sciences Approved 2023-04-11 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)