No statistically significant differences were observed between paroxetine and a placebo on either primary or secondary measurements of effectiveness. These findings are not inconsistent with the findings for many antidepressants studied in the treatment of pediatric patients. The authors do not approve of the use of paroxetine with children and adolescents, and they recommend that all patients who receive antidepressant medicines be closely observed for clinical worsening of depressive symptoms and/or the emergence of any new symptoms, including thoughts of suicide. The 206 patients included in the study were enrolled at 40 centers in the United States and 1 center in Canada from March 2000 to January 2001. The sample included male and female children 7-11 years old and adolescents 12-17 years old who met DSM-IV diagnostic criteria for major depressive disorder (MDD). The diagnosis of MDD and the presence of any comorbid psychiatric disorders were confirmed with the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version. Patients were excluded if they had a clinically predominant Axis I disorder other than MDD. Subjects received paroxetine (10-50 mg/day) or a placebo for 8 weeks from 2000 to 2001. The primary measure of effectiveness was a change from baseline in the Children's Depression Rating Scale-Revised total score at the last observation. Safety was assessed primarily by the reporting of adverse experiences. 3 tables, 2 figures, and 31 references