Placebo-Controlled Trial of Sertraline in the Treatment of Children With Generalized Anxiety Disorder

• Published in: The American journal of psychiatry Vol. 158; no. 12; pp. 2008 - 2014
• Main Authors: Rynn, Moira A., Siqueland, Lynne, Rickels, Karl
• Format: Journal Article
• Language: English
• Published: Washington, DC American Psychiatric Publishing 01.12.2001; American Psychiatric Association
• Subjects: Adolescent; Anxiety; Anxiety disorders; Anxiety Disorders - diagnosis; Anxiety Disorders - drug therapy; Anxiety Disorders - psychology; Biological and medical sciences; Child; Child, Preschool; Children; Children & youth; Clinical trials; Dose-Response Relationship, Drug; Double blind studies; Double-Blind Method; Drug Administration Schedule; Drugs; Female; Humans; Male; Medical sciences; Mental disorders; Neuropharmacology; Personality Assessment; Pharmacology. Drug treatments; Psycholeptics: tranquillizer, neuroleptic; Psychology. Psychoanalysis. Psychiatry; Psychopharmacology; Sertraline - adverse effects; Sertraline - therapeutic use; Human; Serotonin; Psychotropic; Toxicity; Treatment efficiency; Anxiety disorder; Controlled therapeutic trial; Reuptake inhibitor; Sertraline; Dose activity relation; Chemotherapy; School age; Treatment; Tranquillizer; Generalized anxiety disorder; Follow up study; Adolescent; Placebo; Child; Comparative study
• ISSN: 0002-953X; 1535-7228
• DOI: 10.1176/appi.ajp.158.12.2008

OBJECTIVE: The study compared the safety and efficacy of sertraline, a selective serotonin reuptake inhibitor, and placebo in the treatment of generalized 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 the Anxiety Disorders Interview Schedule for Children-Revised and who had a Hamilton Anxiety Rating Scale score ≥16. The patients underwent a 2-3-week prestudy evaluation period, followed by a 9-week double-blind treatment phase in which they were randomly assigned in blocks of four to receive either sertraline or pill placebo. The maximum dose of sertraline 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 somatic 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 at the end of treatment. CONCLUSIONS: The results of this double-blind, placebo-controlled trial suggest that sertraline at the daily dose of 50 mg is safe and efficacious for the treatment of generalized anxiety disorder in children and adolescents.