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IRCT201110127462N2 IRCT 2011-10-19 Tehran University of Medical Sciences Efficacy and complication of Duloxetine in attention deficeit –hyperactivity disorder (ADHD) and comparison with Ritalin Efficacy and complication of Duloxetine in attention deficeit –hyperactivity disorder (ADHD) and comparison with Ritalin 2011-10-23 anticipated 40 Complete https://irct.ir/trial/7925 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A attention deficiency hyperactivity disorder. Intervention 1: Intervention group: Duloxetine 1/4 capsule in the first week, 1/2 capsule in second week, 3/4 capsule in third week and 1 capsule in fourth week. Intervention 2: Control group: according to Ritalin dosage 0.4-1.3 mg/kg, Ritalin 1 capsule for the first week (1/2 in the morning and 1/2 at noon), 2 capsule for the second week (1 capsule in the morning and 1 capsule at noon); if the weight of patient is more than 30 kg, 3 capsule will be daily prescribed for the third week (1 capsule in the morning and 1 capsule at noon and 1 capsule in the afternoon).
public Rozita Jalilian
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN
Tehran Iran (Islamic Republic of) +98 21 5541 3540 rozita_jalilian@yahoo.com Psychiatry research center, Tehran University of Medical Sciences scientific Mohammad Reza Mohammadi
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN.
Tehran Iran (Islamic Republic of) +98 21 5541 3540 pprct@sina.tums.ac.ir Psychiatry and Psychology Research Center, Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: diagnostic criteria based on DSM IV for children with ADHD, age range 11-18, no consumption of any effective psychological drugs in past two week Exclusion criteria: mental retardation, any other psychological disorders except for ODD, history of allergy to Duloxetine, serious medical conditions such as heart disease, uncontrolled convulsive disorder, systolic pressure upper than 125 mmhg or resting pulse less than 60 or more than 115 bit/m 11 years 18 years Both F90.0 Disturbance of activity and attention Treatment - Drugs Treatment - Drugs Intervention group: Duloxetine 1/4 capsule in the first week, 1/2 capsule in second week, 3/4 capsule in third week and 1 capsule in fourth week Control group: according to Ritalin dosage 0.4-1.3 mg/kg, Ritalin 1 capsule for the first week (1/2 in the morning and 1/2 at noon), 2 capsule for the second week (1 capsule in the morning and 1 capsule at noon); if the weight of patient is more than 30 kg, 3 capsule will be daily prescribed for the third week (1 capsule in the morning and 1 capsule at noon and 1 capsule in the afternoon) Attention deficiency hyperactivity disorder. Timepoint: Baseline, 2, 4, 6, 8 weeks after treatment. Method of measurement: CANERS test for parents (summerized and edited format) and ADHD rating scale for parents and teacher. Drugs side effects. Timepoint: Baseline, 2,4,6,8 weeks after treatment. Method of measurement: side effect questionnaire. Tehran University of Medical Sciences Approved 2011-06-12 Tehran University of Medical Sciences Qods street, Keshavarz Blvd, Tehran Tehran Iran (Islamic Republic of)