Placebo-controlled trial of sertraline in the treatment of children with generalized anxiety disorder

Objective: The study compared the safety and efficacy of sertraline, a sele ctive serotonin reuptake inhibitor, and placebo in the treatment of general ized anxiety disorder in children and adolescents. Method: The study subjects were 22 children and adolescents age 5-17 years who met the DSM-IV criteria for generalized anxiety disorder according to t he Anxiety Disorders Interview Schedule for Children-Revised and who had a Hamilton Anxiety Rating Scale score greater than or equal to 16. The patien ts underwent a 2-3-week prestudy evaluation period, followed by a 9-week do uble-blind treatment phase in which they were randomly assigned in blocks o f four to receive either sertraline or pill placebo. The maximum dose of se rtraline was 50 mg/day. Primary outcome measures were the Hamilton anxiety scale and the Clinical Global impression scale. Results: The Hamilton anxiety scale total score, psychic factor, and somati c factor and the Clinical Global Impression severity and improvement scales showed significant differences with treatment in favor of sertraline over placebo beginning at week 4. Self-report measures reflected these results a t the end of treatment. Conclusions: The results of this double-blind, placebo-controlled trial sug gest that sertraline at the daily dose of 50 mg is safe and efficacious for the treatment of generalized anxiety disorder in children and adolescents.