Open-label olanzapine treatment in five preadolescent children.

Olanzapine is a recently introduced atypical neuroleptic agent for which little information is available on its use in children. Open clinical trials of olanzapine treatment were conducted on five hospitalized children (ages 6 to 11 years) with varying diagnoses including bipolar disorder, psychosis not otherwise specified, schizophrenia, and attention-deficit/ hyperactivity disorder. Each patient had failed previous psychotropic medication trials, with a mean of four prior trials. The mean length of olanzapine treatment was 32 days (range, 2 to 7 weeks), and mean daily dose was 7.5 mg/day (range, 2.5 to 1.0 mg/day) or 0.22 mg/kg/day (range, 0.12 to 0.29 mg/kg/day). All children experienced adverse effects, including sedation (N = 3), weight gain of up to 16 pounds (N = 3), and akathisia (N = 2). Three patients showed some clinical improvement, but olanzapine treatment was discontinued in all five children within the first 6 weeks of treatment because of adverse effects or lack of clinically significant therapeutic response, although higher (or lower) doses, slower titration of dosage, or a longer duration of treatment might have produced more favorable results. Psychotic symptoms did not respond in the two patients with evidence of overt hallucinations and paranoid ideation. Improvement was observed in sleep in all five patients and in control of aggression in three. Before controlled trials of olanzapine in children are undertaken, further exploration of dose range and increased duration of treatment on an open basis are warranted. Until more encouraging data are available, clinicians should be cautious and conservative in their predictions about the potential value of olanzapine in treating preadolescent psychiatric disorders.