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IRCT2016080829268N1 IRCT 2017-06-11 Vice Chancellor for Research , Arak University of Medical Sciences Evaluation of the efficacy of memantine in children with attention deficit hyperactivity disorder A Comparison of the Effect of Memantine added to Ritalin and Ritalin alone on cognitive Functions (Selective Attention, Sustained Attention, and Reverse Shot-term Memory) of Children with Attention Deficit and Hyperactivity Disorder (ADHD): A Clinical Trial 2016-04-25 anticipated 76 Complete https://irct.ir/trial/23571 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Attention deficit hyperactivity disorder. Intervention 1: Intervention Group: The research variables including severity of disorder, sustained attention, selective attention and reverse short-term memory were measured using Conners’ teacher and parent rating scales to measure attention deficit/hyperactivity disorder (ADHD), Conners’ Continuous Performance Test (Conners’ CPT Test), Stroop Test and Wechsler Test, respectively. All these tests were done in the morning and, if possible, at a specific time. After the tests, Ritalin tablet was prescribed according to a pediatric psychiatrist based on a dosage mentioned in a comprehensive and evidence-based listing book of dosage recommendations (Ritalin 10mg of Novartis Pharmaceuticals Corporation) at a dosage of 5 mg twice a day (½ tablet twice a day). If it has been well-tolerated, this dosage was increased to 10 mg twice a day and the Memantine Tablet (Alzantin 5mg TAB produced by Sobhan Pharmaceuticals Corporation) was administered simultaneously based on child’s weight (According to previous studies, Memantine dosage is set in terms of children’s weight). If the child weighs more than 60 kg, 39-60 kg, 20-30 kg, less than 20 kg, a maximum daily dosage of 15 mg, 9mg, 6mg and 3mg is prescribed, respectively. The starting dosage of Memantine is 2.5 mg (½ Memantine 5mg Tab). If the previous dosage has been well-tolerated, 5 mg is added weekly to this dosage in terms of the target dosage and Memantine should be consumed for one month based on target dosage. After one month, the cognitive tests are repeated and the two groups are asked again to complete Conners’ teacher and parent rating scales. Intervention 2: Control Group: After obtaining informed consents from parents, The research variables including severity of disorder, sustained attention, selective attention and reverse short-term memory were measured using Conners’ teacher and parent rating scales to measure attention deficit/hyperactivity disorder (ADHD), Conners’ Continuous Performance Test (Conners’ CPT Test), Stroop Test and Wechsler Test, respectively. All these tests were done in the morning and, if possible, at a specific time. After the tests, Ritalin tablet was prescribed according to a pediatric psychiatrist based on a dosage mentioned in a comprehensive and evidence-based listing book of dosage recommendations (Ritalin 10mg of Novartis Pharmaceuticals Corporation) at a dosage of 5 mg twice a day (½ tablet twice a day). If it has been well-tolerated, this dosage was increased to 10 mg twice a day. After one month, the cognitive tests are repeated and Conners’ rating scales are completed by parents and teachers again.
public Dr. Omidi Fahimeh
Postcode 3819693345, A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
Arak Iran (Islamic Republic of) 3819693345 +98 33 1360 5558 f.omidi@arakmu.ac.ir Arak University of Medical Sciences scientific Dr. Omidi Fahimeh
Postcode 3819693345, A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
Arak Iran (Islamic Republic of) 3819693345 +98 33 1360 5558 amoozesh@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: The presence of hyperactivity disorder for both groups in children aged between 7-12 years old according to Statistical Manual of Mental Disorders, Fourth Edition (DSMIV). Exclusion Criteria: The presence of neurological disorders; mental retardation disorders; disorders causing a decreased level of consciousness at the testing time; autism disorder; bipolar disorders; psychosis; depression and anxiety in terms of interviews with pediatric psychiatrist as well as drug side effects which led to drug intolerance. 7 years 12 years Both F90-F98 mental and behavioural disorders Treatment - Drugs Treatment - Drugs Intervention Group: The research variables including severity of disorder, sustained attention, selective attention and reverse short-term memory were measured using Conners’ teacher and parent rating scales to measure attention deficit/hyperactivity disorder (ADHD), Conners’ Continuous Performance Test (Conners’ CPT Test), Stroop Test and Wechsler Test, respectively. All these tests were done in the morning and, if possible, at a specific time. After the tests, Ritalin tablet was prescribed according to a pediatric psychiatrist based on a dosage mentioned in a comprehensive and evidence-based listing book of dosage recommendations (Ritalin 10mg of Novartis Pharmaceuticals Corporation) at a dosage of 5 mg twice a day (½ tablet twice a day). If it has been well-tolerated, this dosage was increased to 10 mg twice a day and the Memantine Tablet (Alzantin 5mg TAB produced by Sobhan Pharmaceuticals Corporation) was administered simultaneously based on child’s weight (According to previous studies, Memantine dosage is set in terms of children’s weight). If the child weighs more than 60 kg, 39-60 kg, 20-30 kg, less than 20 kg, a maximum daily dosage of 15 mg, 9mg, 6mg and 3mg is prescribed, respectively. The starting dosage of Memantine is 2.5 mg (½ Memantine 5mg Tab). If the previous dosage has been well-tolerated, 5 mg is added weekly to this dosage in terms of the target dosage and Memantine should be consumed for one month based on target dosage. After one month, the cognitive tests are repeated and the two groups are asked again to complete Conners’ teacher and parent rating scales. Control Group: After obtaining informed consents from parents, The research variables including severity of disorder, sustained attention, selective attention and reverse short-term memory were measured using Conners’ teacher and parent rating scales to measure attention deficit/hyperactivity disorder (ADHD), Conners’ Continuous Performance Test (Conners’ CPT Test), Stroop Test and Wechsler Test, respectively. All these tests were done in the morning and, if possible, at a specific time. After the tests, Ritalin tablet was prescribed according to a pediatric psychiatrist based on a dosage mentioned in a comprehensive and evidence-based listing book of dosage recommendations (Ritalin 10mg of Novartis Pharmaceuticals Corporation) at a dosage of 5 mg twice a day (½ tablet twice a day). If it has been well-tolerated, this dosage was increased to 10 mg twice a day. After one month, the cognitive tests are repeated and Conners’ rating scales are completed by parents and teachers again. Symptoms of hyperactivity and impulsivity. Timepoint: Before and one mounth after intervention. Method of measurement: Conners questionnaire for parents and teachers. Sustained attention. Timepoint: Continuous Performance Test (CPT). Method of measurement: Before and one mounth after intervention. Selective attention. Timepoint: stroop test. Method of measurement: Before and one mounth after intervention. Reverse short-term memory. Timepoint: Wechsler Digit Span Test. Method of measurement: Before and one mounth after intervention. Adverse effect of Memantine. Timepoint: During the intervention and one month after intervention. Method of measurement: Observation and parents' narration. Vice Chancellor for Research , Arak University of Medical Sciences Approved 2010-09-23 Ethics committee of Arak University of Medical Sciences Arak university of medical sciences ,Basij Sq,Sardasht,Arak Arak Iran (Islamic Republic of)