Le. Sanchez et al., A PILOT-STUDY OF CLOMIPRAMINE IN YOUNG AUTISTIC-CHILDREN, Journal of the American Academy of Child and Adolescent Psychiatry, 35(4), 1996, pp. 537-544
Objective: To assess the short-term efficacy and safety of clomipramin
e in hospitalized young children with autism. Method: This was an open
pilot study; after a 1-week placebo baseline, subjects were treated w
ith clomipramine for 5 weeks. Dosage was individually regulated; start
ing dose was 25 mg/day; increments were 25 mg/day. Maximum dose was 25
0 mg/day or 5.0 mg/kg per day, whichever was less. Multiple raters, un
der 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 t
reatment after having urinary retention on two occasions. At doses ran
ging 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 Consens
us Ratings. Untoward effects were common. Conclusions: Clomipramine wa
s not therapeutic and was associated with serious untoward effects in
this sample. Young autistic children may be more prone to experience u
ntoward effects than older patients.