Risperidone is a drug used in Psychiatric Medicine to treatment cases of Schizophrenia, a form of insanity. It acts on certain specific receptors on the brain that help to modify the behavior of persons so afflicted.

Autism is a developmental disability of unknown etiology, initiated by at least 6 to 7 major genes and about 3 to 4 times that number of minor genes, causing a wide variety of medical pathologies. One of those genes that may have something to do with the presence of the HOXA1 gene coupled with the presence of mercury in the body. the metal gets incorporated into the neural proteins to cause their dysfunction. This causes the characteristic abnormal dissociated behavior patterns seen in children with Autism Spectrum disorder.

Now comes an unusual trial report that Risperidone may have at least short-term benefits in Autism, when used at a low dosage.

The Report

Pediatrics. 2004;114:e634-e641

Risperidone is well-tolerated and effective at treating behavioural symptoms associated with pervasive developmental disorders (PDD) and autism, according to the results of a randomised trial published in the November issue of Pediatrics.

"As yet, there are no pharmacological interventions that specifically target the core deficits of the PDD profile," write Sarah Shea, MD, from IWK Health Centre and Dalhousie University in Halifax, Nova Scotia, Canada, and colleagues. "Risperidone is an antagonist of both dopamine (D2) and serotonin (5HT2A and others) receptors. Particularly when used at lower doses, risperidone proved to be relatively free of the extrapyramidal symptoms (EPSs) that had limited the use of conventional agents."

In this eight-week, double-blind trial, 79 children, aged five to 12 years with PDD, were randomized to receive risperidone (0.01 to 0.06 mg/kg/day) or placebo solution. Mean risperidone dosage was 0.04 mg/kg/day (1.17 mg/day). Outcomes included behavioral scores on the Aberrant Behavior Checklist (ABC), Nisonger Child Behavior Rating Form (N-CBRF), and Clinical Global Impression-Change (CGI-C), as well as safety assessments including vital signs, electrocardiogram, EPSs, adverse events, and laboratory tests.

Compared with the placebo group, children in the risperidone group had a significantly greater mean decrease on the irritability subscale of the ABC, which was the primary endpoint. By study termination, improvement over baseline in the irritability score was nearly twice as high in the risperidone group as in the placebo group (64% vs 31%).

The risperidone group also fared significantly better on the other four subscales of the ABC; on the conduct problem, insecure-anxious, hyperactive, and overly sensitive subscales of the N-CBRF (parent version); and on the Visual Analog Scale (VAS) of the most troublesome symptom. Global improvement occurred in 87% of subjects treated with risperidone and in 40% of the placebo group.

Somnolence was the most frequently reported adverse event, occurring in 72.5% of subjects treated with risperidone and in 7.7% of the placebo group. However, this adverse effect responded to dose-dose-schedule modification. Compared with the placebo group, subjects treated with risperidone had statistically significantly greater increases in weight (2.7 vs 1.0 kg), pulse rate, and systolic blood pressure, but EPS scores were comparable between groups.

The main limitation of this study is the relatively short duration of treatment.

"Risperidone was well tolerated and efficacious in treating behavioral symptoms associated with PDD in children," the authors write. "Risperidone was significantly more effective than placebo at alleviating irritability, hyperactivity/noncompliance, inappropriate speech, lethargy/social withdrawal, stereotypic behavior, conduct problems, hyperactive, insecure/anxious, and overly sensitive behaviors and the symptom identified as most troublesome....The encouraging efficacy outcomes achieved with this agent offer new hope for the management of behavioral symptoms exhibited by children with PDD."

Adapted from Web-MD news

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