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IRCT20190714044199N1 IRCT 2019-11-10 Medical Science University of Mashhad Efficacy of N-Acetyl cysteine in patients with autism spectrum disorder Evaluating the efficacy of adding N-Acetyl cysteine to risperidone treatment regimen in patients with autism spectrum disorder 2019-08-23 anticipated 66 Complete https://irct.ir/trial/41209 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sixty-six ASD children will be selected by convenience sampling population. Eligible patients will be included in the diagnostic interview. Samples will be randomly assigned to each group and divided into two groups of 33 individuals, Blinding description: The psychiatrist, the psychiatric assistant evaluating the results, and the patient are unaware of the type of medication prescribed. 3 Autism spectrum disorder. Intervention 1: Case group: 33 patients treated with risperidone tablets with a maximum dose of 1.5 mg daily and n-acetylcysteine tablets 600 mg daily. Intervention 2: Control group: 33 patients treated with risperidone tablets with a maximum dose of 1.5 mg daily and placebo pills daily. 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 The research is not finished yet
public Pakravan Parisa
Ibne-sina hospital, Buali square, Mashhad, Iran.
Mashhad Iran (Islamic Republic of) 919583134 +98 51 3711 2701 pakravanp961@mums.ac.ir Mashhad University of Medical Sciences scientific Hebrani Paria
Ibne-sina hospital, Buali square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 919583134 +98 51 3711 2701 hebranip@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Autism spectrum disorder (ASD) patients aging between 3 to 12 Having parental informed consent IQ score greater than 50 based on Wildland Test Receiving risperidone therapy for at least one month Lack of clear organic disease (based on family history and medical records) Clear organic causes include visual and hearing impairment, seizures, trauma cycles, chronic or acute medical disorder, and brain dysfunction. Psychiatric disorders including Toure's syndrome, Fragile X syndrome, schizophrenia, Attension deficit hyperactivity disorder (ADHD) based on structured psychiatric interview conducted by pediatric psychiatrist 3 years 12 years Both If the parents do not cooperate for any reason after entering the study 2- 3- Use of any psychotropic drugs other than risperidone Any unbearable or life-threatening drug side effect or any other illness that requires medication which may interfere with results of this study. F84.0 Childhood autism Treatment - Drugs Treatment - Drugs Case group: 33 patients treated with risperidone tablets with a maximum dose of 1.5 mg daily and n-acetylcysteine tablets 600 mg daily Control group: 33 patients treated with risperidone tablets with a maximum dose of 1.5 mg daily and placebo pills daily Severity of ASD was evaluated by CARS questionnaire. Timepoint: Baseline, 5 and 10 weeks after baseline. Method of measurement: CARS questionnaires. Severity, drug response and drug adverse effects was evaluated by CGI questionnaire. Timepoint: Baseline, 5 and 10 weeks after baseline. Method of measurement: CGI questionnaires. Medical Science University of Mashhad Approved 2019-06-22 Ethics committee of mashhad University of Medical Sciences Ethics Committee on Research, Quraishi Building,daneshgah str, Mashhad, Iran. mashhad Razavi Khorasan Iran (Islamic Republic of)