Sertraline effective for children and adolescents with major depression

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Q&A

Sertraline effective for children and adolescents with major depression

J Fam Pract. 2004 January;53(1):8-24

By

Kimberly Hritzak, PharmD, Resident

Nicole S. Culhane, PharmD, BCPS

BACKGROUND: Few treatment options are available for children and adolescents with major depressive disorder due to a lack of efficacy data, particularly with tricyclic antidepressants. Although limited evidence supports the use of selective serotonin reuptake inhibitors (SSRIs), increased adverse effects have been reported with paroxetine (Paxil) and venlafaxine (Effexor). Fluoxetine (Prozac) is the only SSRI approved by the US Food and Drug Administration for the treatment of major depressive disorder in children and adolescents.
POPULATION STUDIED: These 2 studies included 376 children and adolescents aged 6 to 17 years who were diagnosed with major depressive disorder as determined by the Diagnostic and Statistical Manual of Mental Disorders (4th ed) criteria.
STUDY DESIGN AND VALIDITY: Both studies were multicenter, randomized, double-blind, placebo-controlled trials evaluating the effects of sertraline (n=189) compared with placebo (n=187) in children and adolescents with major depressive disorder. Subjects were randomly assigned to receive a flexible dose of sertraline (50–200 mg) or matching placebo for 10 weeks.
OUTCOMES MEASURED: The primary efficacy outcome measure was the CDRS-S scale, with input provided by subjects, parents, and clinicians blinded to group assignment. Secondary efficacy outcomes included a proportion of CDRS-S responders, defined as patients having at least a 40% decrease in the total adjusted CDRS-S score. In addition, scores on the CGI-I and proportion of CGI-I responders, defined as patients with a CGI-I score of 2 or lower, were also used as secondary efficacy measures. Other scales were used to assess anxiety symptoms, social functioning, and quality of life.
RESULTS: A total of 69% of subjects in the sertraline group and 59% in the placebo group responded to treatment using the CDRS-R evaluation (P=.05; number needed to treat [NNT]=10). In addition, 63% of subjects in the sertraline group and 53% of subjects in the placebo group responded to treatment using the CGI-I evaluation (P=.05; NNT=10). There were no statistically significant differences between groups in any of the patientrated secondary outcomes.

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Sertraline effective for children and adolescents with major depression

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