Multicenter open-label sertraline study in adolescent outpatients with major depression

Objective: The aim of this multicenter outpatient study was to assess the t herapeutic benefits, response patterns, and safety of sertraline in adolesc ent major depressive disorder (MDD). Method: Fifty-three adolescent outpati ents with MDD were treated in an open-label, 10-week, acute-phase trial wit h sertraline and, if responders, for an additional 12-week continuation pha se. Diagnostic and response assessments included the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS), 17-item K-SA DS-derived depression severity score, Hamilton Depression Rating Scale, Bec k Depression Inventory, and Clinical Global Impression Scale. Results: By 2 weeks, when analyzed as continuous variables, all severity scores showed s ignificant differences from baseline. This pattern persisted through 10 wee ks, with a significantly greater response occurring when treatment was exte nded from 6 to 10 weeks. Both clinician- and patient-rated improvement was maintained during continuation treatment. Response rates varied considerabl y when depression rating scales were analyzed categorically. Sertraline was generally well tolerated and did not induce manic symptoms. Conclusions: I n open treatment of adolescent MDD with sertraline, significant improvement occurred early on and was maintained for 22 weeks. Absolute response rates varied depending on the rating scales used, definition of response, and le ngth of treatment. Maximal response rates were obtained by clinician-define d ratings after 10 weeks of treatment.