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IRCT2016042027506N1 IRCT 2016-05-16 Vice chancellor for research, Tehran University of Medical Sciences Donepezil effect in Executive Function of Hyperactivity Disorder Comparison of Donepezil and Placebo as adjunctive therapy with Ritalin on Executive Functioning of children with Attention Deficit Hyperactivity Disorder 2016-05-04 anticipated 40 Complete https://irct.ir/trial/22513 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 attention deficit hyperactivity disorder. Intervention 1: Intervention group (1): After the initial evaluation(Connor's parent questionnaire, IQ test,CANTAB test) and gaining the consent of the children and their parents, Ritalin medication at 0.5 milligrams per kilogram of body weight begins. This dosage is divided into hours of 8 am, 12 am, and 4 pm. In addition to Ritalin, this group received Donepezil. Donepezil is among the acetylcholinesterase inhibitors. In this study, Donepezil tablet manufactured by Pfizer Germany Aricept commercial name has been used and is administered orally. Dosage Week Zero: studies have shown that 2.5 mg is easily tolerated, so the dose starts of 2.5 mg at night and will be raised to 5 mg after 2 weeks. After two weeks, digestive problems and irritable or other complications are asked through a phone call to family. If no report of side effects was given, the dose remains constant until the end of week 4. Week 4: patients refer to hospital in person. Drug side effects questionnaire and a Connor's parent questionnaire are asked to be filled, then the CANTAB test is administered. After assessments, Ritalin will continue with the previous dosage and Donepezil will reach 7.5 mg by week 6. In week 6, with a phone call the family is asked to report gastrointestinal problems or other symptoms. If no report of side effects was given, a dose of 10 mg is administered in weeks 7 and 8. Week 8: Patients refer in person. Drug side effects questionnaire and the Conners Parent Scale and General Clinical Assessment are filled and then CANTAB test is run. Intervention 2: The intervention group (2): After the initial evaluation (Connor's parent questionnaire, IQ test,CANTAB test) and gaining the consent of the children and their parents, Ritalin medication at 0.5 milligrams per kilogram of body weight begins. This dosage is divided into hours of 8 am, 12 am, and 4 pm. In addition to Ritalin, this group receive placebo. The content of placebo is Starch. Placebo pills in identical shape and size in the same package with Donepezil are prepared. At the end of week two, digestive problems and irritation or other complications are asked through a phone call to family. At week 4 patients refer to hospital in person. Drug side effects questionnaire and a Connor's parent questionnaire are asked to be filled, and then the CANTAB test is administered. In week 6, with a phone call the family is asked to report gastrointestinal problems or other symptoms. At week 8: patients refer in person. First, drug side effects questionnaire and a Connor's parent questionnaire are asked to be filled, and then the CANTAB test is administered.
public Parisa Pakdel
Rozbeh Hospital, not far from the Qazvin Square, Sought Kargar Ave.
Tehran Iran (Islamic Republic of) +98 21 5541 9154 p-pakdel@razi.tums.ac.ir Tehran University of Medical Science scientific Zahra Shahrivar
Rozbeh Hospital. not far from the Gazvin Square. Sought Kargar Ave.
Tehran Iran (Islamic Republic of) +98 21 5540 9495 sharivar@sina.tums.ac.ir Tehran Univercity of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. Age of six to twelve years; 2. DSM-5 criteria for a diagnosis of ADHD; 3. IQ above 90. Exclusion criteria: 1. an intervening physical disorder such as neurological disorders, a record of severe allergic reaction to Ritalin or Donepezil, record of heart disease; 2. a major psychiatric disease such as mood disorders, psychotic disorders, substance abuse. 4 years 12 years Both f90-0 Disturbance of activity and attention Attention deficit: disorder with hyperactivity hyperactivity disorder syndrome with hyperactivity Excl.: hyperkinetic disorder associated with conduct disorder Treatment - Drugs Treatment - Drugs Intervention group (1): After the initial evaluation(Connor's parent questionnaire, IQ test,CANTAB test) and gaining the consent of the children and their parents, Ritalin medication at 0.5 milligrams per kilogram of body weight begins. This dosage is divided into hours of 8 am, 12 am, and 4 pm. In addition to Ritalin, this group received Donepezil. Donepezil is among the acetylcholinesterase inhibitors. In this study, Donepezil tablet manufactured by Pfizer Germany Aricept commercial name has been used and is administered orally. Dosage Week Zero: studies have shown that 2.5 mg is easily tolerated, so the dose starts of 2.5 mg at night and will be raised to 5 mg after 2 weeks. After two weeks, digestive problems and irritable or other complications are asked through a phone call to family. If no report of side effects was given, the dose remains constant until the end of week 4. Week 4: patients refer to hospital in person. Drug side effects questionnaire and a Connor's parent questionnaire are asked to be filled, then the CANTAB test is administered. After assessments, Ritalin will continue with the previous dosage and Donepezil will reach 7.5 mg by week 6. In week 6, with a phone call the family is asked to report gastrointestinal problems or other symptoms. If no report of side effects was given, a dose of 10 mg is administered in weeks 7 and 8. Week 8: Patients refer in person. Drug side effects questionnaire and the Conners Parent Scale and General Clinical Assessment are filled and then CANTAB test is run. The intervention group (2): After the initial evaluation (Connor's parent questionnaire, IQ test,CANTAB test) and gaining the consent of the children and their parents, Ritalin medication at 0.5 milligrams per kilogram of body weight begins. This dosage is divided into hours of 8 am, 12 am, and 4 pm. In addition to Ritalin, this group receive placebo. The content of placebo is Starch. Placebo pills in identical shape and size in the same package with Donepezil are prepared. At the end of week two, digestive problems and irritation or other complications are asked through a phone call to family. At week 4 patients refer to hospital in person. Drug side effects questionnaire and a Connor's parent questionnaire are asked to be filled, and then the CANTAB test is administered. In week 6, with a phone call the family is asked to report gastrointestinal problems or other symptoms. At week 8: patients refer in person. First, drug side effects questionnaire and a Connor's parent questionnaire are asked to be filled, and then the CANTAB test is administered. Change in severity of symptoms of Attention Deficit Hyperactivity Disorder, according to the opinion of therapist and family. Timepoint: weeks zero, four, and eight. Method of measurement: Conners Parent Scale and General Clinical Assessment. Change in mean scores of the CANTAB computer test of executive functions (working memory, planning skills, capacity of working memory, response inhibition and impulse control, measuring argument). Timepoint: weeks zero, four, and eight. Method of measurement: CANTAB computer test. Vice chancellor for research, Tehran University of Medical Sciences Approved 2016-04-12 Ethics Committee Tehran University of Medical Sciences Central Organization of University, Ghods Ave, Keshavarz Blvd. Tehran Iran (Islamic Republic of)