A pilot study of clomipramine in young autistic children.

OBJECTIVE

To assess the short-term efficacy and safety of clomipramine in hospitalized young children with autism.

METHOD

This was an open pilot study; after a 1-week placebo baseline, subjects were treated with clomipramine for 5 weeks. Dosage was individually regulated; starting dose was 25 mg/day; increments were 25 mg/day. Maximum dose was 250 mg/day or 5.0 mg/kg per day, whichever was less. Multiple raters, under several conditions, used the Children's Psychiatric Rating Scale, Clinical Global Impressions, Conners Parent Teacher Questionnaire, and the Clinical Global Consensus Ratings.

RESULTS

Eight children, aged 3.5 to 8.7 years, were enrolled in the study; seven of these completed the study. A 3.5-year-old boy was excluded during the third week of treatment after having urinary retention on two occasions. At doses ranging from 2.50 to 4.64 mg/kg per day (mean = 3.14), one child improved moderately and six were rated as worse on the Clinical Global Consensus Ratings. Untoward effects were common. CONCLUSIONS; Clomipramine was not therapeutic and was associated with serious untoward effects in this sample. Young autistic children may be more prone to experience untoward effects than older patients.