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IRCT20090117001556N104 IRCT 2017-12-25 Tehran University of Medical Sciences Resveratrol in treatment of autism Resveratrol add on therapy to risperidone in irritibility of children with autism: a randomized double-blind placebo-controlled clinical trial 2018-01-08 anticipated 50 Complete https://irct.ir/trial/28378 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random permuted block, Blinding description: The participants, clinicians and outcome raters will be blind regarding grouping. 3 autistic disorder. Intervention 1: Intervention group: Tablet Resveratrol( 500 mg per day) plus Risperidone ( 1 to 3.5 mg per day) for 12 weeks. Intervention 2: Control group: Tablet placebo plus Risperidone( 1 to 3.5 mg per day) for 12 weeks. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2020 to 2025 To whom: Academic researchers Conditions: En by citing the resourse Where to obtain: Professor Shahin Akhondzadeh How to obtain: by e mail Comments:
public Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences scientific Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) DSM-5 clinical diagnosis of autistic disorder children between the ages of 3 and 12 years presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone) 3 years 12 years Both Presence of any active medical problem other psychiatric diagnosis except for mild to moderate Intellectual disability receiving any antipsychotic medications during past monthprior to the trial severe hepatic disease history of allergy to risperidone and intolerance of it History of seizure requiring change of antiepileptic dose during the last month seizure during the last 6 months F84.0 Autistic disorder Treatment - Drugs Placebo Intervention group: Tablet Resveratrol( 500 mg per day) plus Risperidone ( 1 to 3.5 mg per day) for 12 weeks Control group: Tablet placebo plus Risperidone( 1 to 3.5 mg per day) for 12 weeks Severity of autism. Timepoint: Baseline and weeks 4, 8 and 12. Method of measurement: By Aberrant Behavior Checklist-Community( ABC-C) and Childhood Autism Rating scale( CARS). Tehran University of Medical Sciences Approved 2018-01-08 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz Blv Tehran Tehran Iran (Islamic Republic of)