An Open Trial of Risperidone in Young Autistic Children

doi:10.1097/00004583-199804000-00014

Journal of the American Academy of Child & Adolescent Psychiatry

Volume 37, Issue 4, April 1998, Pages 372-376

https://doi.org/10.1097/00004583-199804000-00014 Get rights and content

ABSTRACT

Objective

To assess the benefits and side effects of risperidone in young autistic children.

Method

In this open, prospective trial, subjects were treated with risperidone for 12 weeks. All subjects were started at 0.5 mg daily with individual titration to a maximum of 6 mg or 0.1 mg/kg daily. Behavioral ratings, completed by the investigators and the children's parents, included the Clinical Global Impressions (CGI), Children's Psychiatric Rating Scale, Conners Parent-Teacher Questionnaire, Childhood Autism Rating Scale, and Abnormal Involuntary Movement Scale.

Results

Ten boys, aged 4.5 to 10.8 years, were enrolled in the study and all completed the 12-week protocol. The mean final dose was 1.3 mg/day (range = 1 to 2.5 mg/day). On the basis of CGI-rated improvement, 8 of the 10 children were considered to be responders. Improvement was also demonstrated on the other scales. Transient sedation was common, and the children gained an average of 3.5 kg over the 12 weeks of the study. There was no evidence of either extrapyramidal symptoms or tardive dyskinesia.

Conclusions

These results suggest that risperidone may be safe and leads to improvements in several behavioral symptoms in young children with autism. Controlled studies of risperidone in young autistic children are warranted. J. Am. Acad. Child Adolesc. Psychiatry, 1998, 37(4):372–376.

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Clinical Global Impression-Improvement (CGI-I) (DiLalla and Rogers, 1994), a single item recorded at the end of the study rating behavior from 1 (‘very much improved’) to 7 (‘very much worsened’), was also applied to compare the severity of global symptomatology before and after switching to aripiprazole. These instruments have been used extensively in psychopharmacological studies of children and adolescents with PDD (Masi et al., 2003; Nicolson et al., 1998; Zuddas et al., 2000). Results of CGI-S scores are presented as mean ± SD differences.
Subjects with Pervasive Developmental Disorders (PDD) often exhibit behavioral symptoms such as aggressiveness and irritability, which are targets of psychopharmacologic intervention. This retrospective study was designed to examine children and adolescents with PDD experiencing tolerability issues with risperidone treatment, and thereby assess the efficacy and tolerability of switching to aripiprazole.
This naturalistic study included 23 subjects with PDD (16 males, 7 females, age range 9–24 years, mean age 15.1 ± 3.9 years) diagnosed according to DSM-IV criteria and followed up for 14.9 ± 8.4 weeks after switching to aripiprazole from risperidone. Outcome measures were the Clinical Global Impression-Severity (CGI-S) and CGI Improvement (CGI-I) scales.
The mean CGI-S scores of pre-aripiprazole treatment and post-aripiprazole treatment were, respectively 4.7 ± 1.4 and 4.6 ± 1.3. Mean maintenance dosages of risperidone and aripiprazole were, respectively, 0.7 ± 0.5 mg/day and 2.8 ± 1.3 mg/day. The mean CGI-I score, which shows the difference induced by switching from risperidone to aripiprazole, was 3.4 ± 0.8 for the whole sample, suggesting that the efficacy of risperidone for treating behavioral problems of PDD was maintained by aripiprazole. Some improvement of safety/tolerability issues such as increased appetite, somnolence, hyperprolactinemia, and amenorrhea occurred after switching to aripiprazole.
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View all citing articles on Scopus

: The authors thank Dr. Judith Rapoport for her editorial comments and Mr. Peter Sansom of Janssen-Ortho Inc. for providing the risperidone used in this study.

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ARTICLESAn Open Trial of Risperidone in Young Autistic Children

ABSTRACT

Objective

Method

Results

Conclusions

Developmental Profile II

Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)

The effects of haloperidol on discrimination learning and behavioral symptoms in autistic children

J Autism Dev Disord

Haloperidol in the treatment of infantile autism: effects on learning and behavioral symptoms

Am J Psychiatry

Clinical relationship of extrapyramidal symptoms and tardive dyskinesia

Can J Psychiatry

Autism: towards an integration of clinical, genetic, neuropsychological, and neurobiological perspectives

J Child Psychol Psychiatry

A comparison of haloperidol and behavior therapy and their interaction in autistic children

J Am Acad Child Psychiatry

Neuroleptic-related dyskinesias in autistic children: a prospective, longitudinal study

J Am Acad Child Adolesc Psychiatry

Measurement of side effects including tardive dyskinesia

Psychopharmacol Bull

Behavioral and cognitive measures used in psychopharmacological studies of infantile autism

Psychopharmacol Bull

Treatment of autistic disorder

J Am Acad Child Adolesc Psychiatry

Treatment of risperidone-induced obsessive-compulsive symptoms with sertraline

Am J Psychiatry

An open clinical trial of risperidone monotherapy in young autistic children

Psychopharmacol Bull

A double-blind comparison of clomipramine, desipramine, and placebo in the treatment of autistic disorder

Arch Gen Psychiatry

ARTICLES
An Open Trial of Risperidone in Young Autistic Children