SERTRALINE TREATMENT OF CHILDREN AND ADOLESCENTS WITH OBSESSIVE-COMPULSIVE DISORDER OR DEPRESSION - PHARMACOKINETICS, TOLERABILITY AND EFFICACY

Objective: To evaluate the pharmacokinetics, safety and efficacy of se rtraline in children (6 to 12 years old) and adolescents (13 to 17 yea rs old), Method: Children (n = 29) and adolescents (n = 32) with major depression, obsessive-compulsive disorder (OCD), or both received a s ingle dose of 50 mg of sertraline followed, 1 week later, by 35 days o f sertraline treatment as follows: (1) either a starting dose of 25 mg /day titrated to 200 mg/day in 25-mg increments or (2) a starting dose of 50 mg/day titrated to 200 mg/day in 50-mg increments. Sertraline a nd desmethylsertraline pharmacokinetics were determined approximately weekly, and efficacy measures were assessed before drug administration and at the end of treatment. Results: Mean area under the plasma conc entration-time curve (AUG), peak plasma concentration (C-max), and eli mination half-life (t(1/2)) for sertraline and desmethylsertraline wer e similar to previously reported adult values. No titration-dependent pharmacokinetic or safety differences were seen. White C-max and AUC(0 -24) were greater for children versus adolescents, these differences d isappeared after parameters were normalized for body weight. Sertralin e was well tolerated in both children and adolescents, with adverse ex periences similar to those previously reported by adult patients, Effi cacy measurements indicated improvement (p < .001) in depression and O CD symptomatology. Conclusions: Sertraline can be safely administered to pediatric patients using the currently recommended adult titration schedule.