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Objective: Autism Spectrum Disorders (ASD) are early onset neurodevelopmental disorders defined in terms of abnormalities in social and communication development in the presence of marked repetitive behavior and narrow interests (American Psychiatric Association, 2000). Risperidone and aripiprazole are the two atypical neuroleptics approved by FDA for the treatment of irritability associated with autism. We aimed to investigate the efficacy, tolerability and side effects of aripiprazole in children with ASD.
Method: The records of ASD outpatients were analyzed by retrospective scanning of the registry in our clinic. The severity of the disorder was evaluated with “Clinical Global Impression Scale/Severity” (CSI-S), the degree of improvement during the observation with “Clinical Global Impression Scale/Improvement” (CSI-I) and the adverse effect of the drug with “Clinical Global Impression Scale/Adverse Effect Severity”.
Results: Among the patients diagnosed with ASD, data for 101 were reached. In 15 cases (14%), transitions from alternative antipsychotic treatments to aripiprazole were observed. 86,7%(n=13) of the 15 cases were male and 13,3% (n=2) were female. The average age of the cases was found as 9,50±3,87. 66.7% (n=10) of the cases had at least one and 26.7% (n=4), had more than one comorbid disorders. The most common comorbid disorder was observed as Attention Deficit Hyperactivity Disorder. 80% (n=12) of the cases had Autism Disorder, 13,3% (n=2) had Asperger Disorder and 6,7% (n=1) had Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS) diagnoses. Reasons for switching to aripiprazole during the treatment were identified as; 73,3% (n=11), getting no benefit out of the treatment,54,3% (n=8), significant weight gain, 40% (n=6) development of gynecomastia, 26,7% (n=4) increase in prolactin levels. The mean dose of aripiprazole was 4,61±3,80. At the beginning of aripiprazole treatment, according to the CGI-S scores, cases showed the following distribution: 53,3% (n=8) of the cases were at the significant level, 40,0% (n=6) were at the moderate level and 6,7% were at severe level. (n=1). According to the assessment of CGI-I, the degree of improvement of the cases were found as: 13,3% (n=2) “improved very well”, 26,7% (n=4) “quite improved”, 33,5% (n=5) “slightly improved”, 20,0% (n=3) “ no improvement”, 6,7% (n=1) “ worsened considerably”. While 73,3% (n=11) of the cases showed no adverse effects during the treatment, 20,0% (n=3) of them showed some irritability that does not affect the functionality significantly. In only one of the cases (6,7%) some irritability and agitation affecting the functionality considerably occurred, and for this case, aripiprazole treatment was ended.
Conclusion: In PDD outpatients, it is observed that aripiprazole is tolerated well and as an alternative to other antipsychotics; it can be used safely and effectively. New patient recruitment for the study is ongoing. Findings should be supported with controlled studies having more samples.