TY - JOUR
T1 - Olanzapine versus placebo in adolescents with schizophrenia
T2 - A 6-week, randomized, double-blind, placebo-controlled trial
AU - Kryzhanovskaya, Ludmila
AU - Schulz, S. Charles
AU - McDougle, Christopher
AU - Frazier, Jean
AU - Dittmann, Ralf
AU - Robertson-Plouch, Carol
AU - Bauer, Theresa
AU - Xu, Wen
AU - Wang, Wei
AU - Carlson, Janice
AU - Tohen, Mauricio
AU - Kryzhanovskaya, Ludmila A.
N1 - Funding Information:
This work was sponsored by Eli Lilly and Company.
PY - 2009/1
Y1 - 2009/1
N2 - 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.
AB - 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.
KW - Efficacy
KW - Olanzapine
KW - Schizophrenia
KW - Tolerability
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U2 - 10.1097/CHI.0b013e3181900404
DO - 10.1097/CHI.0b013e3181900404
M3 - Article
C2 - 19057413
AN - SCOPUS:58249139362
SN - 0890-8567
VL - 48
SP - 60
EP - 70
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 1
ER -