Olanzapine versus placebo in the treatment of adolescents with bipolar mania.
OBJECTIVE
The purpose of this study was to evaluate the efficacy and safety of olanzapine for the treatment of acute manic or mixed episodes associated with bipolar disorder in adolescents.


METHODS
A 3-week multicenter, parallel, double-blind, randomized placebo-controlled trial was conducted at 24 sites in the United States and two sites in Puerto Rico. The participants were outpatient and inpatient male and female adolescents 13-17 years of age with an acute manic or mixed episode. Subjects received either olanzapine (2.5-20 mg/day [N=107]) or placebo (N=54). The mean change from baseline to endpoint in the Young Mania Rating Scale total score was the primary outcome measure.


RESULTS
The mean baseline-to-endpoint change in the Young Mania Rating Scale total score was significantly greater for patients receiving olanzapine relative to patients receiving placebo, and a greater proportion of olanzapine-treated patients met response and remission criteria (44.8% versus 18.5% and 35.2% versus 11.1%, respectively). The mean baseline-to-endpoint weight change was significantly greater for patients receiving olanzapine relative to patients receiving placebo (3.7 kg versus 0.3 kg), and the incidence of treatment-emergent weight gain > or =7% of baseline was higher for olanzapine-treated patients (41.9% versus 1.9%). The mean baseline-to-endpoint changes in prolactin, fasting glucose, fasting total cholesterol, uric acid, and the hepatic enzymes aspartate transaminase and alanine transaminase were significantly greater in patients treated with olanzapine relative to patients receiving placebo.


CONCLUSIONS
Olanzapine was effective in the treatment of bipolar mania in adolescent patients. Patients treated with olanzapine, however, had significantly greater weight gain and increases in the levels of hepatic enzymes, prolactin, fasting glucose, fasting total cholesterol, and uric acid.
Tohen
Mauricio
M
Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285, USA. m.tohen@lilly.com
Kryzhanovskaya
Ludmila
L
Carlson
Gabrielle
G
Delbello
Melissa
M
Wozniak
Janet
J
Kowatch
Robert
R
Wagner
Karen
K
Findling
Robert
R
Lin
Daniel
D
Robertson-Plouch
Carol
C
Xu
Wen
W
Dittmann
Ralf W
RW
Biederman
Joseph
J
D000293:Adolescent; D000367:Age Factors; D000410:Alanine Transaminase / Q000097:blood; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000097:blood / Q000188:drug therapy* / Q000523:psychology; D001786:Blood Glucose / Q000032:analysis; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D006801:Humans; D008297:Male; D009765:Obesity / Q000139:chemically induced; D000077152:Olanzapine; D010919:Placebos; D011388:Prolactin / Q000097:blood; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D014527:Uric Acid / Q000097:blood; D015430:Weight Gain / Q000187:drug effects
D014150:Antipsychotic Agents; D001786:Blood Glucose; D010919:Placebos; D001569:Benzodiazepines; D014527:Uric Acid; D011388:Prolactin; D002784:Cholesterol; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000077152:Olanzapine