Long-term sertraline treatment of children and adolescents with major depressive disorder.
OBJECTIVE
The aim of this study was to assess the long-term safety, tolerability, and efficacy of sertraline 50-200 mg once-daily in children (6-11 year olds) and adolescents (12-18 year olds) with a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of major depressive disorder (MDD).


METHODS
This study consisted of a 24-week open-label observational study of children and adolescents who had completed either of two 10-week double-blind, placebo-controlled trials. The Children's Depression Rating Scale-Revised (CDRS-R) was the primary measure of efficacy.


RESULTS
Two hundred ninety nine (299) patients completed the acute studies and were eligible for the extension study. Of these, 226 enrolled, but 5 did not receive treatment. Of 221 patients (107 children and 114 adolescents), 62.4% completed the study. The endpoint mean daily dose was 109.9 mg/day. The mean decrease in CDRS-R score from double-blind baseline was 34.8 points (p < 0.001), with patients showing continued improvement in CDRS-R scores regardless of which treatment they received in the double-blind studies. At endpoint, 86% of patients met CDRS-R responder and 58% CDRS-R remitter criteria.


CONCLUSIONS
Sertraline appears to be well tolerated and safe over 24 weeks of treatment in children and adolescents with MDD. Children and adolescents treated with sertraline appear to have increased improvement over that seen in the first 10 weeks of treatment. These findings need confirmation in placebo-controlled studies.
Rynn
Moira
M
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA. MRYNN2@mail.med.upenn.edu
Wagner
Karen Dineen
KD
Donnelly
Craig
C
Ambrosini
Paul
P
Wohlberg
Christopher J
CJ
Landau
Phyllis
P
Yang
Ruoyong
R
D000293:Adolescent; D002648:Child; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008134:Long-Term Care; D008297:Male; D012141:Respiratory Tract Infections / Q000139:chemically induced / Q000453:epidemiology; D020280:Sertraline / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome
D020280:Sertraline