OBJECTIVE: There is evidence for the efficacy and safety of clonazepam (CZP) in adult anxiety disorders, but no formal studies to substantiate clinical reports of similar benefit in children with anxiety disorders. METHOD: In this double-blind pilot study, 15 children, aged 7 to 13 years, entered a randomly assigned, double-blind crossover trial of 4 weeks of CZP (up to 2 mg/day) and 4 weeks of placebo. RESULTS: Twelve children completed the trial. All but 1 had a diagnosis of separation anxiety disorder, and all but 2 had comorbid diagnoses. Nine children appeared to have moderate to significant clinical improvement, but statistical comparisons on several ratings failed to confirm a trend in favor of CZP. Side effects of drowsiness, irritability, and/or oppositional behavior were notable in 10 children in the CZP phase compared with 5 in the placebo phase. CONCLUSIONS: Clonazepam was believed to have clinical benefit for some children, but this was not confirmed statistically in this small sample. Problematic side effects of drowsiness and disinhibition were common and possibly were due to rapid titration.
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