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IRCT201106306923N1 IRCT 2011-11-04 Iran University of Medical Sciences The Efficacy of Stimdate and Ritalin in Children with ADHD: A Comparative, Double-Blind, Randomized, Clinical Trial Comparison of the Efficacy of two brands of Methylphenidate (Stimdate® with Ritalin®) in Children and Adolescents with Attention Deficit Hyperactivity Disorder: A Double-Blind, Randomized, Clinical Trial 2008-04-20 anticipated 30 Complete https://irct.ir/trial/7374 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A ADHD. Intervention 1: Intervention Group: In this group 15 subjects with ADHD were treated with Stimdate® as follow: Starting with 5 mg at morning and noon and weekly increments by 5mg in each dose to reach the dose of 20mg at morning and noon in the 4th week. The dose of the 5th and 6th week was determined according to best response to doses. Intervention 2: The control group contained 15 subjects who were treated with Ritalin® as follow: Starting with 5 mg at morning and noon and weekly increments by 5mg in each dose to reach the dose of 20mg at morning and noon in week four. The dose of Ritalin in the 5th and 6th week was determined according to best response to doses.
public Elham Shirazi
No.1, Shahid Mansouri St., Niayesh St., Sattarkhan Ave.
Tehran Iran (Islamic Republic of) 1443813444 +98 21 6650 6862 shirazi_elham@yahoo.com Mental Health Research Center scientific Elham Shirazi
No1. Shahid Mansouri St., Niayesh St., Sattarkhan Ave.
Tehran Iran (Islamic Republic of) 1443813444 +98 21 6650 6862 shirazi_elham@yahoo.com Mental Health Research Center Iran (Islamic Republic of) Inclusion criteria: age 6-16 years old; Presence of mixed AD/HD according to Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV), No psychological medication in 2 weeks prior to the study; signing informed written consent of parents to participate in the study; the ability to comply study visits schedule. Exclusion criteria: Presence of clinically significant gastrointestinal problems, cardiovascular disease, glaucoma, seizure disorder, psychotic disorder, clinical depression, or Tourette's syndrome; Co-morbid conditions including oppositional defiant disorder or conduct disorder, pervasive developmental disorder, depression, or learning disorders 6 years 16 years Both F90 A group of disorders characterized by an early onset (usually in the first five years of life), lack of persistence in activities that require cognitive involvement, and a tendency to move from one activity to another without completing any one, together Treatment - Drugs Treatment - Drugs Intervention Group: In this group 15 subjects with ADHD were treated with Stimdate® as follow: Starting with 5 mg at morning and noon and weekly increments by 5mg in each dose to reach the dose of 20mg at morning and noon in the 4th week. The dose of the 5th and 6th week was determined according to best response to doses. The control group contained 15 subjects who were treated with Ritalin® as follow: Starting with 5 mg at morning and noon and weekly increments by 5mg in each dose to reach the dose of 20mg at morning and noon in week four. The dose of Ritalin in the 5th and 6th week was determined according to best response to doses. Clinical Profile of illness reported by parents. Timepoint: 4th and 6th week. Method of measurement: The Standard Persian version of Conner’s parent rating scale-revised (CRS-R) was used for the assessment of ADHD in children and adolescents. Efficacy of treatment. Timepoint: 4th and 6th week. Method of measurement: The Clinical Global Impressions (CGI) Scale used to rate the symptoms change over time, and efficacy of medication, taking into account the patient’s clinical condition by clinicians. Symptoms severity reported by parents. Timepoint: 0,4,6 weeks. Method of measurement: The Child Symptom Inventory-4 (CSI-4) (ADHD part): is also used to measure Symptom Severity scores by teachers and parents24-25. The internal consistency reliability for CSI-4 in literature reported to be 0.74-0.94 and have acceptable criterion validity. Illness severity. Timepoint: 4th and 6th week. Method of measurement: The Children’s Global Assessment Scale (CGAS) is used to measure the overall severity of disturbance in children. The CGI and CGAS showed acceptable reliability and validity scores in different studies. Drug side effects. Timepoint: 4th and 6th week. Method of measurement: checklist by clinical interview and exam. Iran University of Medical Sciences Approved 2009-06-23 Ethics committee of Iran University of Medical Sciences faculty of medicine, Iran University of Medical Sciences, Hemmat Exp. Tehran Iran (Islamic Republic of)