Risperidon and Atomoxetine in the Treatment of Several and Challending Behaviors in Children with PDD.

Abstract

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.