ADouble-Blind Placebo-Controlled Pilot Study of Olanzapine in Childhood/Adolescent Pervasive Developmental Disorder

Abstract

Atypical antipsychotics have been shown to improve disruptive and repetitive behaviors in pervasive developmental disorders (PDDs), but they require assessment of potential side effects. This is the first placebo-controlled trial of olanzapine in the treatment of children and adolescents with PDD. Eleven patients with a diagnosis of either autism, Asperger's syndrome, or PDD not otherwise specified (PDD-NOS) and aged 6-14 years were randomized into an 8-week double-blind, placebo-controlled, parallel treatment study with olanzapine. There was a significant linear trend x group interaction on the Clinical Global Impressions- Improvement (CGI-I) and 50% on olanzapine versus 20% on placebo were responders. Olanzapine was associated with significant weight gain (7.5 +/- 4.8 lbs vs. 1.5 +/- 1.5 lbs on placebo). Olanzapine may be a promising treatment for improving global functioning of PDDs, but the risk of significant weight gain remains a concern. Additional studies are needed to determine the efficacy and safety of olanzapine in the treatment of children with PDD.

Assessment and Treatment of Obsessions and Compulsions in Individuals with Autism Spectrum Disorders: a Systematic Review

“…Olanzapine Hollander et al (2006b), in a double-blind RCT including 11 children with ASD, compared olanzapine (M= 10 mg/day) to a placebo over 8 weeks. There were no significant changes in CY-BOCS compulsive behavior.…”

Antipsychotics in the treatment of autism

“…One small placebo-controlled study of olanzapine has been published (74). In this study, 11 patients with PDD were randomized to olanzapine (mean dose, 10 mg/d) or placebo for 8 weeks.…”

Pharmacobiological Treatments in Autism Spectrum Disorders

“…SSRIs block the re-uptake of serotonin at the synapse, thus increasing the availability of serotonin and the activation of serotonin receptors [15]. In children and adults, SSRIs have shown limited positive outcome, although all the studies have been with small sample sizes, with potential risk of bias [16,17]. In addition, SSRIs such as olanzapine, and fluvoxamine, have been shown to have undesirable side effects including irritability and weight gain [16,18].…”

“…In children and adults, SSRIs have shown limited positive outcome, although all the studies have been with small sample sizes, with potential risk of bias [16,17]. In addition, SSRIs such as olanzapine, and fluvoxamine, have been shown to have undesirable side effects including irritability and weight gain [16,18]. A large multi-center, double-blinded, randomized controlled trial has been recently started known as Fluoxetine for Autistic Behaviors (FAB trial) to determine the efficacy of low-dose fluoxetine for treating ASD symptoms in children and adolescents [19].…”