The purpose of this study is to determine the efficacy (how well the drug works), safety,
and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar
disorder in adolescents. Both the potential benefits and side effects of olanzapine will be
evaluated throughout this trial.
- Male or female patients, 13 to 17 years of age who must not yet have reached their
18th birthday prior to Visit 1, when informed consent is obtained.
- Patients must have a diagnosis of bipolar I disorder and currently display an acute
mania or mixed episode.
- Both the patient and the patient's parent/authorized legal representative must
understand the nature of the study and must sign a document granting consent.
- Female patients of child-bearing potential must test negative for pregnancy at the
time of enrollment based on a serum pregnancy test.
- Female patients who are either pregnant or nursing.
- Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective
- Patient with acute or unstable medical conditions, such that intensive care unit
hospitalization for the disease is anticipated within 6 months.
- Patients who have previously not responded to an adequate dose and/or duration of
- Patients who have been judged clinically to be serious suicidal risks.