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Introduction: Efficacy and safety of Levetiracetam and Risperidone for aggression irritability, and hyperactivity in adolescent with autism spectrum disorder (ASD) are controversial Objectives: The sudy of Levetiracetam and Risperidone efficacy and safety for aggression and mood instability in ASD adolescents. Methods: 66 adolescents with ASD (MD = 14,6) were randomized into three groups: Lvetiracetam + Risperidone (A), Placebo + Risperidone(B) and Placebo +Levetiracetam (C) for an 8-week, placebo-controlled study with the use of flexible doses of Risperidone (1.0-3.0 mg; MD = 2,3) and LCT(1000.0 - 2000.0 mg; MD = 1580 mg). Patients were assessed at baseline and after 2, 4, 6 and 8 weeks of therapy. We used: DAYS, MASC, LSAS-CA, YBOCS, ADHD-IV, SCQ, ASDS, RAASI, SSRS, GAF. Groups were considered the independent variable, and five measurements during treatment were considered as the dependent variable for themultiple regression analysis. Results: Compared with the group B, patients of group C demonstrated improved symptoms of hyperactivity, impulsivity and mood instability. No treatment difference was observed between A and B groups for the SCQ, ASDS, RAASI and SSRS. Changes in groupAwere greater than in C and B. The GAF score in the patients improved significantly from 39.00±7.36 before therapy to 58.00± 9.12 after risperidone (F = 30.16, df = 1, p < 0.001) and to 64.00 ± 8.21 after Levetiracetam + Risperidone (F = 33.89, df = 1, p < 0.001). Conclusions: Risperidone is useful in treating behavioral problems; adding Levetiracetam to Risperidone was more effective for irritability and stereotyped behavior. [ABSTRACT FROM AUTHOR]

Introduction The most frequent targets for pharmacologic intervention in PDD patients include associated comorbid conditions: hyperactivity, inattention, compulsive-like behaviors, anxiety, depression, aggression, self-injurious behavior, repetitive or stereotypic behaviors, and sleep disturbances [1-2]. Objective To compare efficacy and tolerability of risperidone and atomoxetine in the treatment of severe and challenging behaviors in children with PDD. Methods Was conducted 8-week double-blind, placebo-controlled study with parallel group of comparison and flexible doses of Risperidon (1.0-3.0 mg; MD = 1,8) and Atomoxetine (25.0 – 40.0 mg; MD = 32,8). Were randomized 80 children from 12 to 18 years old (MD = 10,8) with the assessment ≥ 6 points on the diagnostic criteria for DSM IV-TR for autism, ≥12 balls Irritability by ABC-C. All children were assessed by an additional ADI-R, ADOS. Drug efficacy was assessed weekly using the ABC-C, CGI-I / CGI-S, Adverse event recording. Result Risperidone and Atomoxetine are more effective than placebo in Irritability, Agitation, Crying subscales (F = 2,30, DF = 1,47, P = 0,12), Hyperactivity, Noncompliance (F = 103,24, DF = 1,68, ? ≤ 0,0001), Lethargy, Social Withdrawal (F = 2,30, DF = 1,47, P = 0,12), Stereotypic Behavior (F = 27,94, DF = 1,24, ? ≤ 0,0001). In Risperidone therapy was observed Inappropriate Speech retardation, and more frequently extra pyramidal side effects. Conclusion Risperidon (1.0-3.0 mg / day) and Atomoxetine (25.0 – 40.0 mg / day) are more effective than placebo and well-tolerated and can be recommended for treatment of severe and challenging behaviors in children with PDD. [ABSTRACT FROM AUTHOR]