January 15, 1999

Children and adolescents with obsessive-compulsive disorder (OCD) can be treated effectively and safely with sertraline hydrochloride (Zoloft), suggests a new study in the November 25 issue of the Journal of the American Medical Association.

The first multicenter, short-term trial of sertraline in nonadults with OCD showed significantly greater improvement in OCD symptoms after 12 weeks. Fifty-three percent of patients receiving sertraline experienced a significant decrease in OCD symptoms as measured by the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) compared with 37 percent who received a placebo.

Forty-two percent of patients taking sertraline were rated very much or much improved, compared with 26 percent receiving placebo, on the National Institute of Mental Health Clinical Global Impressions of Improvement (CGI-I) rating scale. Clinically significant differences in mean scores for the two treatment groups emerged after three weeks and persisted throughout the study.

John March, M.D., M.P.H., and his colleagues from several institutions studied 187 children and adolescents (107 children aged 6 to 12 and 80 adolescents aged 13 and 17) who had been diagnosed with OCD over 12 weeks to evaluate the safety and effectiveness of sertraline. Ninety-two patients were randomized to receive sertraline, and 95 patients were randomized to receive placebo. Each group included children and adolescents. March is director of the program for child and adolescent anxiety disorders in the psychiatry department at Duke University Medical Center in Durham, N.C.

The starting sertraline dose was 25 mg in children and 50 mg in adolescents, according to the report. The drug was titrated up at fixed doses of 50 mg per week to a maximum of 200 mg at the fourth week, which was maintained during the next eight weeks of the trial.

Eighty percent of the sertraline-treated patients and 86 percent of the placebo-treated patients completed the 12-week double-blind trial. Thirteen percent of sertraline subjects discontinued treatment because of adverse reactions such as insomnia, nausea, agitation, and tremor compared with 3 percent of placebo subjects. The others discontinued for various reasons including insufficient clinical response and being lost to follow-up.

However, the authors noted that the study did not "reveal significant differences in adverse effects between children and adolescents. Thus, the same dosing regimen used in adults appears appropriate for children and adolescents."

The researchers recommended that clinicians start patients on 50 mg of sertraline daily, moving to maximum doses by six to eight weeks for nonresponders or partial responders, for an adequate acute trial duration of 10 to 12 weeks.

Despite clinically meaningful treatment benefits, the average patient treated with sertraline remained in the mildly ill range on the CY-BOCS at the end of treatment. "Thus, most experts agree that the best clinical results can be achieved by combining pharmacotherapy with OCD-specific cognitive-behavioral psychotherapy," according to authors.

Judith Rapoport, M.D., chief of the Child Psychiatry Branch, Intramural Research Program, at the National Institute of Mental Health, wrote in an accompanying editorial, "OCD has its onset in childhood or adolescence in approximately half the cases, and at least half of these cases benefit significantly from drug treatment."

Rapoport pointed out that this new study "now adds a third serotonin uptake inhibiting drug, along with clomipramine and fluvoxamine, that has been demonstrated to be effective in children and adolescents in large multicenter trials."