Background: Aripiprazole, a novel antipsychotic, is an effective and safe agent in psychotic disorders of adults but with limited evidence of use in pediatric patients. This study compares efficacy and safety of aripiprazole monotherapy with haloperidol for schizophrenia and related psychotic disorders in children and adolescents.
Methods and Materials: Total 30 patients with ICD-10 DCR diagnosis of schizophrenia and acute psychotic disorders, were assigned to receive either aripiprazole (10-15 mg/day) or haloperidol (10-15mg/day) for four weeks, with each group containing 15 patients respectively. Primary outcome measure was Positive and Negative Syndrome Scale for Schizophrenia (PANSS) while secondary outcome measures were three PANSS subscales and Clinical Global Impressions-Severity of Illness (CGI-S). Assessments were done at baseline and then on weekly basis until endpoint. Extrapyramidal side effects and akathisia were rated weekly by Simpson-Angus Scale (SAS) and Barnes Akathisia Scale (BAS). Body weight and serum prolactin were measured and electrocardiogram recorded at baseline and at end point.
Results: Endpoint improvement for the aripiprazole group was not significantly different from haloperidol group on PANSS total score, and PANSS positive and negative subscale scores. Haloperidol produced significantly greater improvement in PANSS general psychopathology subscale score and CGI-S score at endpoint. Aripiprazole produced significantly less extrapyramidal side effects and weight gain. Haloperidol produced significantly greater elevations in serum prolactin levels while QT(c) changes were nonsignificant in both groups.
Conclusions: This trial shows that aripiprazole therapy was as efficacious as haloperidol in improving both positive and negative symptoms of psychotic disorders in children and adolescents but demonstrated better tolerability
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