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IRCT20160530028182N7 IRCT 2019-11-03 Sanandaj University of Medical Sciences Effect of Buspirone in ADHD Comparison Methylphenidate and Buspirone as Adjuant therapy in children with ADHD treated by Methylphenidate mono therapy 2018-09-23 anticipated 50 Complete https://irct.ir/trial/36421 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual based-simple randomization, Blinding description: The drug is prepared by the pharmacist and in coding packages which only the pharmacist is aware of its coding and deliverd by researcher to the patient. Neither the investigator, nor the patient nor the analyst, knows the contents of the drug packages and the way they are coded. 2 Attention deficit/hyperactivity disorder. Intervention 1: Intervention group: A group of randomly selected patients received methylphenidate tablets (10 mg) for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 PM) and the second week (half the tablet at 8:00 am and half the tablet at 4:00 PM). ) and from the third week afterwards (one tablet at 8:00 am and one tablet at 4:00 PM) with a capsule containing Buspirone powder for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 pm) and the second week (half the tablet at 8:00 am andhalf the tablet at 4:00 pm) and after the third week (one tablet at 8:00 am and one tablet at 4:00 pm). Intervention 2: Control group: A group of randomly selected patients received methylphenidate tablets (10 mg) for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 PM) and the second week (half the tablet at 8:00 am and half the tablet at 4:00 PM). ) and from the third week afterwards (one tablet at 8:00 am and one tablet at 4:00 PM) with a capsule containing placebo powder for the first week (1.25 mg at 8:00 am and 1.25 mg at 4:00 pm) and the second week (2.5 mg at 8:00 am and 2.5 mg at 4:00 pm) and after the third week (5 mg at 8:00 am and 5 mg at 4:00 pm). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available
public Dr.Soleiman Mohammadzadeh
Pasdaran street Sanandaj
Sanandaj Iran (Islamic Republic of) 66614713446 +98 87 3366 4653 dr.mohammadzadeh86@muk.ir Sanandaj University of Medical Sciences scientific Dr.Soleiman Mohammadzadeh
Pasdaran street Sanandaj
ُSanandaj Iran (Islamic Republic of) 66614713446 +98 87 3366 4653 dr.mohammadzadeh86@muk.ac.ir Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age between 6 -12 years Diagnosis of ADHD and ODD based on DSM5 without effective medication taking on mental status at least 2 weeks before the study 6 years 12 years Both Intelectual disability based on clinical suspicious presence of uncontroled siezure Drug side effects and hypersensivity Recieving of any other drugs History of psychological disorder except for ADHD and ODD presence of medical deasese such as cardiac deaseses F90 Attention-deficit hyperactivity disorders Treatment - Drugs Treatment - Drugs Intervention group: A group of randomly selected patients received methylphenidate tablets (10 mg) for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 PM) and the second week (half the tablet at 8:00 am and half the tablet at 4:00 PM). ) and from the third week afterwards (one tablet at 8:00 am and one tablet at 4:00 PM) with a capsule containing Buspirone powder for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 pm) and the second week (half the tablet at 8:00 am andhalf the tablet at 4:00 pm) and after the third week (one tablet at 8:00 am and one tablet at 4:00 pm). Control group: A group of randomly selected patients received methylphenidate tablets (10 mg) for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 PM) and the second week (half the tablet at 8:00 am and half the tablet at 4:00 PM). ) and from the third week afterwards (one tablet at 8:00 am and one tablet at 4:00 PM) with a capsule containing placebo powder for the first week (1.25 mg at 8:00 am and 1.25 mg at 4:00 pm) and the second week (2.5 mg at 8:00 am and 2.5 mg at 4:00 pm) and after the third week (5 mg at 8:00 am and 5 mg at 4:00 pm). Clinical Profile of illness reported by parents. Timepoint: Baselin , second,fourth and eighth weeks after intervention. Method of measurement: Canner's and ADHD Rating scales. Symptoms severity reported by parents. Timepoint: Baselin , second ,fourth and eighth weeks after intervention. Method of measurement: ADHD Rating scale and CGI. Efficacy of treatment. Timepoint: Baselin , second ,fourth and eighth weeks after intervention. 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. Drug side effects. Timepoint: Second, fourth and eighth weeks after intervention. Method of measurement: checklist by clinical interview and exam. Sanandaj University of Medical Sciences Approved 2017-07-24 Ethics committee of Kurdistan University of Medical Sciences Pasdaran street ُSanandaj Kurdistan Iran (Islamic Republic of)