Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials.
BACKGROUND
The efficacy, safety, and tolerability of selective serotonin reuptake inhibitors (SSRIs) in the treatment of adults with major depressive disorder (MDD) are well established. Comparatively few data are available on the effects of SSRIs in depressed children and adolescents.


OBJECTIVE
To evaluate the efficacy and safety of sertraline compared with placebo in treatment of pediatric patients with MDD.


METHODS
Two multicenter randomized, double-blind, placebo-controlled trials were conducted at 53 hospital, general practice, and academic centers in the United States, India, Canada, Costa Rica, and Mexico between December 1999 and May 2001 and were pooled a priori.


METHODS
Three hundred seventy-six children and adolescents aged 6 to 17 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-defined MDD of at least moderate severity.


METHODS
Patients were randomly assigned to receive a flexible dosage (50-200 mg/d) of sertraline (n = 189) or matching placebo tablets (n = 187) for 10 weeks.


METHODS
Change from baseline in the Children's Depression Rating Scale-Revised (CDRS-R) Best Description of Child total score and reported adverse events.


RESULTS
Sertraline-treated patients experienced statistically significantly greater improvement than placebo patients on the CDRS-R total score (mean change at week 10, -30.24 vs -25.83, respectively; P =.001; overall mean change, -22.84 vs -20.19, respectively; P =.007). Based on a 40% decrease in the adjusted CDRS-R total score at study end point, 69% of sertraline-treated patients compared with 59% of placebo patients were considered responders (P =.05). Sertraline treatment was generally well tolerated. Seventeen sertraline-treated patients (9%) and 5 placebo patients (3%) prematurely discontinued the study because of adverse events. Adverse events that occurred in at least 5% of sertraline-treated patients and with an incidence of at least twice that in placebo patients included diarrhea, vomiting, anorexia, and agitation.


CONCLUSIONS
The results of this pooled analysis demonstrate that sertraline is an effective and well-tolerated short-term treatment for children and adolescents with MDD.
Wagner
Karen Dineen
KD
University of Texas Medical Branch, Department of Psychiatry and Behavioral Sciences, Galveston 77555-0188, USA. kwagner@utmb.edu
Ambrosini
Paul
P
Rynn
Moira
M
Wohlberg
Christopher
C
Yang
Ruoyong
R
Greenbaum
Michael S
MS
Childress
Ann
A
Donnelly
Craig
C
Deas
Deborah
D
D000293:Adolescent; D000928:Antidepressive Agents / Q000627:therapeutic use*; D002648:Child; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011581:Psychological Tests; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D020280:Sertraline / Q000627:therapeutic use*
D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline