Article

Paliperidone for irritability in adolescents and young adults with autistic disorder

Section of Child and Adolescent Psychiatry, Department of Psychiatry, Indiana University School of Medicine, Christian Sarkine Autism Treatment Center, James Whitcomb Riley Hospital for Children, 705 Riley Hospital Drive, Indianapolis, IN 46202-5200, USA.
Psychopharmacology (Impact Factor: 3.88). 05/2012; 223(2):237-45. DOI: 10.1007/s00213-012-2711-3
Source: PubMed

ABSTRACT

Individuals with autistic disorder (autism) frequently exhibit significant irritability marked by severe tantrums, aggression, and self-injury. Despite advances in the treatment of this symptom domain in autism, there remains an ongoing need for more effective and better tolerated pharmacotherapies.
The aim of this study is to determine the effectiveness and tolerability of paliperidone for irritability in autism.
This is a prospective, 8-week open-label study of paliperidone in 25 adolescents and young adults with autism. Primary outcome measures included the Clinical Global Impressions-Improvement (CGI-I) Scale and the Irritability subscale of the Aberrant Behavior Checklist (ABC-I). Concomitant medications (except antipsychotics) were permitted if dosages were stable for ≥2 months.
Twenty-one (84 %) of 25 subjects ages 12-21 years (mean 15.3 years) responded to paliperidone, based on a CGI-I Scale score of 1 or 2 (very much or much improved) and ≥25 % improvement on the ABC-I. The mean final dosage of paliperidone was 7.1 mg/day (range 3-12 mg/day). Two subjects discontinued paliperidone prior to study completion (moderate sedation, n = 1; nonresponse, n = 1). Mild-to-moderate extrapyramidal symptoms were recorded in four subjects. A mean weight gain of 2.2 ± 2.6 kg (range -3.6 to +7.9 kg) was recorded. Mean age- and sex-normed body mass index increased from 23.6 to 24.2 (p ≤ 0.001). Mean serum prolactin increased from 5.3 to 41.4 ng/mL (p ≤ 0.0001).
Paliperidone treatment was associated with significant improvement in irritability and was generally well tolerated. Larger scale, placebo-controlled studies are needed to elucidate the efficacy and tolerability of paliperidone in this population.

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    • "This drug has been found to be effective in children, adolescents and adults with ASD, although the literature is very limited. In all studies it appears to be particularly effective in reducing irritability (Stigler et al., 2010Stigler et al., , 2012Kowalski et al., 2011). Although the clinical use of Paliperidone is increasing it is not supported by clinical Randomized Controlled Trials (RCTs).to "
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    • "It may have an advantage over risperidone in children with hepatic impairment, but paliperidone still shares a similar adverse effect profile as risperidone.17 Currently, published studies on the use of paliperidone in ASD are limited to an open-label trial39 and a few case reports.40,41 According to a recent open-label trial, side effects included weight gain, increased appetite, tiredness, EPS, and increased serum prolactin. "
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    • "The scale shows good reliability, validity, and sensitivity for these disorders [17] [18] [19]. The CGI scale for autism has been previously used successfully as an outcome measure in various trials [20] [21] [22]. "
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