Olanzapine Versus Placebo in Adolescents With Schizophrenia: A 6-Week, Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Objective To assess olanzapine's efficacy and tolerability in adolescents with schizophrenia. Method One hundred seven inpatient and outpatient adolescents (olanzapine, n = 72, mean age 16.1 years; placebo, n = 35, mean age 16.3 years) with schizophrenia participated in this randomized (2:1), international, multisite, industry-sponsored trial. All patients met DSM-IV-TR criteria for schizophrenia, and they were treated for up to 6 weeks with flexible doses of olanzapine (2.5–20.0 mg/day) or placebo. Last-observation-carried-forward mean changes from baseline to endpoint on the anchored version of the Brief Psychiatric Rating Scale for Children, Clinical Global Impression Scale-Severity of Illness, and Positive and Negative Syndrome Scale (PANSS) were assessed. Results More olanzapine-treated versus placebo-treated patients completed the trial (68.1% versus 42.9%, p = .020). Compared with placebo-treated patients, olanzapine-treated adolescents had significantly greater improvement in Brief Psychiatric Rating Scale for Children total ( p = .003), Clinical Global Impressions Scale-Severity of Illness ( p = .004), PANSS total ( p = .005), and PANSS positive scores ( p = .002). Olanzapine-treated patients gained significantly more baseline-to-endpoint weight (4.3 kg versus 0.1 kg, p < .001). Significantly more olanzapine-treated versus placebo-treated patients gained 7% or greater of their body weight at any time during treatment (45.8% versus 14.7%, p = .002). Prolactin and triglyceride mean baseline-to-endpoint changes were significantly higher in olanzapine-treated versus placebo-treated adolescents. The incidence of treatment-emergent significant changes in fasting glucose, cholesterol, or triglycerides did not differ between the groups at endpoint, but significantly more olanzapine-treated patients had high triglycerides at any time during treatment. Conclusions Olanzapine-treated adolescents with schizophrenia experienced significant symptom improvement. Significant increases in weight, triglycerides, uric acid, most liver function tests, and prolactin were observed during olanzapine treatment.