Abstract

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.