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Setraline Effective, Safe for Major Depression in Children: Presented at ECNP

By Bruce Sylvester
Special to DG News

BARCELONA, SPAIN -- October 11, 2002 -- Setraline therapy is effective and safe for paediatric major depression (MDD), researchers reported here at the 15^th meeting of the European College of Neuropsychopharmacology (ECNP).

"Sertraline has been previously shown to be safe and effective in children and adolescents with obsessive-compulsive disorder, and effective in a pilot study of generalised anxiety disorder, but it has not, to date, been studied rigorously in paediatric MDD," noted lead author Karen Wagner, MD, professor of psychiatry at the University of Texas Medical Branch in Galveston, Texas.

Researchers enrolled 376 subjects (177 children, ages 6-11, 199 adolescents, ages 12-17) and randomised them to receive either sertraline (189) or placebo (187).

The investigators conducted two identical 10-week multicenter, double-blind, placebo-controlled, flexible-dose studies of sertraline (50-200 mg/day) with outpatient children and adolescents diagnosed with MDD.

The primary end point was the Children's Depression Rating Scale - Revised (CDRS-R). Secondary end points included the Clinician's Global Impression of Severity and Improvement (CGI-S, CGI-I) scores, Multidimensional Anxiety Scale for Children (MASC), Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q), Children's Global Assessment Scale (CGAS), and responder analyses based on the CDRS-R (>40 percent change from baseline) and CGI-I (score of one or two at end point).

Sertraline subjects achieved a significantly greater mean change in the CDRS-R total score (p=0.007), CGI-I (p=0.009), and CGI-S (p=0.005). They also achieved greater improvement in the treatment-by-visit-week analysis at Week 1 for the CGI-I (p=0.043), at Week 3 for the CGI-S (p=0.032) and for CDRS-R total score (p=0.014).

A significantly higher percentage of sertraline subjects achieved criteria for response based on the CDRS-R (69 versus 59 percent, p=0.050) and CGI-I (63 versus 53 percent, p=0.049).

The investigators saw no significant difference between groups for MASC or CGAS, and change of only borderline significance favouring sertraline in PQ-LES-Q score (p=0.066)

A greater number of children (13.9 percent) than adolescents (3.8 percent) discontinued from the study due to adverse events. Adverse events at greater than 5 percent among sertraline-treated subjects and twice that of placebo-treated subjects included diarrhoea, vomiting, agitation, and anorexia.

The researchers saw no clinically significant differences between the treatment groups for laboratory data, electrocardiograms, or vital signs.

They noted a small but statistically significant decrease in body weight in sertraline subjects compared to placebo.

The investigators concluded that, "These data support the efficacy and safety of sertraline in the treatment of paediatric MDD and contribute to the knowledge base of sertraline in the treatment of paediatric mood and anxiety disorders".

The research was funded by Pfizer Inc.

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