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

OBJECTIVE
The aim of this multicenter outpatient study was to assess the therapeutic benefits, response patterns, and safety of sertraline in adolescent major depressive disorder (MDD).


METHOD
Fifty-three adolescent outpatients with MDD were treated in an open-label, 10-week, acute-phase trial with sertraline and, if responders, for an additional 12-week continuation phase. Diagnostic and response assessments included the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS), 17-item K-SADS-derived depression severity score, Hamilton Depression Rating Scale, Beck Depression Inventory, and Clinical Global Impression Scale.


RESULTS
By 2 weeks, when analyzed as continuous variables, all severity scores showed significant differences from baseline. This pattern persisted through 10 weeks, with a significantly greater response occurring when treatment was extended from 6 to 10 weeks. Both clinician- and patient-rated improvement was maintained during continuation treatment. Response rates varied considerably when depression rating scales were analyzed categorically. Sertraline was generally well tolerated and did not induce manic symptoms.


CONCLUSIONS
In 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 length of treatment. Maximal response rates were obtained by clinician-defined ratings after 10 weeks of treatment.