Children with major depressive disorder aged 6–11 years have a significantly faster first response to both sertraline and a placebo, compared with adolescents aged 12–17 years, Dr. Craig L. Donnelly of Darmouth-Hitchcock Medical Center in Lebanon, N.H., and his colleagues report.
The study, funded by Pfizer Inc., is the first known to examine the differences in time to first response and time to first persistent response in children and adolescents with major depressive disorder (MDD).
The investigators looked at 226 youths with MDD. The 10-week double-blind, placebo-controlled trial was followed by a 24-week open-label trial of sertraline (J. Am. Acad. Child Adolesc. Psychiatry 2006;45:1162–70). All of the patients who received sertraline started with a 25-mg/day dose for 3 days, followed by 50 mg/day through the end of 2 weeks. The dosage was then adjusted to a maximum of 200 mg/day based on the patient's clinical response and the occurrence of side effects.
The estimated median time to first response was 15 days for children and 22 days for adolescents who took sertraline, compared with 21 days for children and 23 days for adolescents who took a placebo The time to first persistent response was significantly shorter in adolescents, but not in younger children, when compared with the placebo.
The estimated median time to first persistent response was 28 days for children and 32 days for adolescents who took sertraline, compared with 28 days for children and 32 days for adolescents who took a placebo. Patients in both age groups showed similar long-term improvements in MDD symptoms by the end of 34 weeks of treatment, and sertraline was generally well tolerated. Significantly more children than adolescents discontinued the study because of adverse events (15% vs. 4%).
Suicide-related events were reported in five patients in the sertraline group (three children, two adolescents) vs. two incidents in the placebo group (one adolescent attempted suicide twice). Those who reported suicide events were taking at least 100 mg of sertraline at the time of the events, but there was no link between the suicide events and any recent increase in the sertraline dose, the autors noted.