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.
RCT Entities:
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 autisticchildren may be more prone to experience untoward effects than older patients.
Authors: Joshua Nadeau; Michael L Sulkowski; Danielle Ung; Jeffrey J Wood; Adam B Lewin; Tanya K Murphy; Jill Ehrenreich May; Eric A Storch Journal: Neuropsychiatry (London) Date: 2011-12
Authors: Macey L Murray; Yingfen Hsia; Karen Glaser; Emily Simonoff; Declan G M Murphy; Philip J Asherson; Hanna Eklund; Ian C K Wong Journal: Psychopharmacology (Berl) Date: 2013-05-17 Impact factor: 4.530