Olanzapine versus placebo in adolescents with schizophrenia: a 6-week, randomized, double-blind, placebo-controlled trial.

Author(s): Kryzhanovskaya L, Schulz SC, McDougle C, Frazier J, Dittmann R, Robertson-Plouch C, Bauer T, Xu W, Wang W, Carlson J, Tohen M

Affiliation(s): Eli Lilly and Company. kryzhanovskayalu@lilly.com

Publication date & source: 2009-01, J Am Acad Child Adolesc Psychiatry., 48(1):60-70.

Publication type: Research Support, Non-U.S. Gov't

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.Clinical trial registration information-Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00051298.