Major depressive disorder, which af...

Major depressive disorder, which affects 3 percent of children and 8 percent of adolescents, is associated with high social and economic charges and may linger into adulthood. Selective serotonin reuptake inhibitors (SSRIs) are considered the best available treatment option for depression in children and adolescents, based forward their efficacy and safety profile in adults; however, the recommendation for use in children and adolescents is based onward limited evidence. Wagner and colleagues report the be deriveds of two identically designed, concurrently managemented 10-week, international, randomized, double-blinded, placebo-controlled, multicenter trials comparing the SSRI sertraline with placebo in children and adolescents with major depressive disorder.

Participants were children and teen six to 17 years of age who met the diagnostic criteria for major depressive disorder. A variety of concomitant psychiatric disorders (such as attention-deficit/hyperactivity disorder and bipolar disorder) serv as exclusion criteria. Patients were randomized to receive sertraline or matching placebo for 10 weeks in a 1:1 ratio. Improvement in depression was measured at their performance on the Children's Depression Rating Scale-Revised (CDRS-R) which includes parent and spectator input. The other scales used in the studies included the Clinical Global Impression of Severity of Illness (CGI-S) scale and the Clinical Global Impression of Improvement (CGI-I) scale.

Of the 376 randomized patients, 189 received sertraline, and 187 received placebo. Forty-six patients receiving sertraline (24 percent) and 31 patients receiving placebo (17 percent) discontinued the investigation early because of adverse marked occurrences withdrawal of consent, or los to follow-up greatest in quantity of those who left the meditation because of adverse events were receiving sertraline.

Patients receiving sertraline demonstrated significantly greater improvement from one side of to the other the course of the research than those receiving placebo, as measured by means of CDRS-R, CGI-S, and CGI-I scores. Statistically significant greater improvement from baseline to the extreme point of the study was noted in patients receiving sertraline forward items of the CDRS-R scale, including irritability, gentle self-esteem, listless speech, excessive weeping, and hypoactivity. No significant change was fix between treatment groups in suicidal ideation, and borderline change was ground for depressed feelings and difficulty having sport Adolescents appeared to have a slightly greater improvement than children.

At subject of attention end point, 69 percent of patients treated with sertraline and 59 percent of patients receiving placebo met the CDRS-R criteria for being responder A similar proportion met responder criteria for the CGI-I scale. The number of ones needed to treat to await a difference in response between sertraline and placebo would be 10 according to the criteria of either scale. The differences between collections on either scale favored sertraline moreover did not reach statistical significance. Sertraline was generally well tolerated if it be not that had an increased incidence of diarrhea, vomiting, agitation, and anorexia.

Sertraline was set up to be more effective than placebo in these trials, with improvement occurring as early as week 3 The authors note that the differences between sertraline and placebo in this reflection are numerically small, but important, particularly when compared with trials using tricyclic antidepressants, which showed no pharmacologic benefit. Sertraline was well tolerated up to a maximum dosage of 200 mg by day. A major limitation of the reflection was its short duration. As with trials in adults, this contemplation showed a high response rate in the placebo group

Wagner KD et al. Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder. pair randomized controlled trials. JAMA August 27 2003; 290:1033-41

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