Sertraline treatment of 5 children diagnosed with selective mutism: a single-case research trial.

In this single-case research study, we examined the efficacy and acceptability of sertraline treatment in children diagnosed with selective mutism. We utilized a double-blind, placebo-controlled trial of sertraline within a replicated multiple baseline/across participants research design (n = 2; n = 3). Multiple methods of assessment involving across-setting informants were completed repeatedly throughout the 16-week study. Follow-up data was collected at 4 and 20 weeks poststudy. Assessment measures failed to demonstrate group changes in mutism, anxiousness, and shyness. All individuals realized considerable improvement on some of these variables. Two of the five participants no longer met diagnostic criteria for selective mutism following less than 10 weeks of 100 mg sertraline treatment. A third participant was reported asymptomatic at 20 weeks poststudy. Treatment compliance was high. Parent treatment acceptability ratings were highly favorable. Single-case research methodology has considerable clinical utility in the medication treatment of selective mutism. Frequent and repeated measurement across phases helped to highlight varying levels of participant improvement across situationally specific settings. Additional investigation of the use of selective serotonin reuptake inhibitors in treating selective mutism is warranted.

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 sertraline in children (6 to 12 years old) and adolescents (13 to 17 years old). METHOD: Children (n = 29) and adolescents (n = 32) with major depression, obsessive-compulsive disorder (OCD), or both received a single dose of 50 mg of sertraline followed, 1 week later, by 35 days of 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 and 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 concentration-time curve (AUC), peak plasma concentration (Cmax), and elimination half-life (t1/2) for sertraline and desmethylsertraline were similar to previously reported adult values. No titration-dependent pharmacokinetic or safety differences were seen. While Cmax and AUC0-24 were greater for children versus adolescents, these differences disappeared after parameters were normalized for body weight. Sertraline was well tolerated in both children and adolescents, with adverse experiences similar to those previously reported by adult patients. Efficacy measurements indicated improvement (p < .001) in depression and OCD symptomatology. CONCLUSIONS: Sertraline can be safely administered to pediatric patients using the currently recommended adult titration schedule.

Pemoline therapy in college students with attention deficit hyperactivity disorder: a retrospective study.

Pemoline, a dopamine agonist, is effective in children with attention deficit hyperactivity disorder (ADHD), but its efficacy in adults is unknown. The authors studied the efficacy and safety of pemoline, using retrospective chart review of treated students with ADHD over a 2-year period. Forty students met diagnostic and treatment criteria; pemoline was associated with much improved or very much improved Clinical Global Impression symptoms scores in 70% of the students during a treatment period of 14 or more days. Severity of illness scores dropped from 4.11 to 3.01 between baseline and subsequent evaluation. Nine evaluable patients had adverse events, most commonly headaches, insomnia, and decreased appetite. Five additional students, who failed to meet the treatment-duration criterion, terminated because of severe initial insomnia. The authors concluded that pemoline is effective and safe in students with ADHD and has a lower abuse potential than methylphenidate and dextroamphetamine, the other two widely used, structurally dissimilar compounds, but controlled studies may be necessary before any final conclusions are reached.

Case report: high plasma level tricyclic antidepressant therapy in children: a case report and commentary.

ABSTRACT It is well known that some adults with major depression fail to respond to tricyclic antidepressants (TCA) at typical doses and plasma levels, but do respond at higher than standard levels. The literature on high-dose TCA treatment and high plasma level treatment in adults is reviewed, along with the more limited literature in children and adolescents. A case is described of a 5-year-old girl with major depression who did not respond to treatment with nortriptyline until the dose was raised to 200 mg daily (7.2 mg/kg, plasma level = 342 ng/ml). She experienced relatively minor side effects at these levels, and showed clinical deterioration when her plasma level was lowered to 188 ng/ml (160 mg/day, 5.8 mg/kg). Her high-dose and plasma level requirement was supported in an ABABA open clinical trial. High-dose, or high plasma level, treatment with tricyclic antidepressants may be a useful therapeutic option for some severely depressed children after more conventional treatments have failed. The general use of high-dose TCA treatment does not seem warranted or safe, but may be valuable for a selected subgroup of patients. Specific treatment guidelines are offered, including criteria for patient selection and monitoring for mild delirium, neurotoxic changes, seizures, electrocardiographic changes, and cardiovascular effects.