[Open study of fluoxetine in children with autism].

INTRODUCTION: Serotonergic dysfunction have been implicated in the pathophysiology of the autism. SRIs have shown efficacy in improving some symptoms in children with Autism.

OBJECTIVES: To evaluate, in a pilot study, the efficacy and safety of fluoxetine in very young children with autism.

METHOD: 1 year open-label trial was made with fluoxetine on 12 patients (3 to 13 years old) with Pervasive Developmental Disorder. CGI-severity was used to assess the severity and the improvement of symptoms. Individual symptoms improvement was assessed by both parents and therapists. Fluoxetine dose was titrated in all patients from 1.2 ml/day to reach a final doses of 3,6 or 5 ml/day in four weeks. Tolerance was assessed by collecting spontaneous adverse events.

RESULTS: 11 children completed the study. Children experienced a moderate or marked improvement (final score in CGI 3 to 5). Communication and attention skills were improved. There were also a decrease of rituals, stereotypies and repetitive behaviours. Most common adverse events were increase of impulsivity and restlessness, other events were sleep disturbances and lost of appetite. 6 children needed concomitant medication with carbamacepine and 1 with levopromacine along the study.

CONCLUSIONS: These results support that Fluoxetine at doses of 5 ml/day (20 mg/day) could help to improve some symptoms in Pervasive Developmental Disordersand allow to increase the effectiveness of therapies in these patients. More studies are needed to confirm these results.