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.

Condition	Treatment or Intervention	Phase
Bipolar Disorder	Drug: Olanzapine	Phase IV

Further Study Details: 

Expected Total Enrollment:  130

Ages Eligible for Study:  13 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Female patients who are either pregnant or nursing.
• Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
• 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 olanzapine treatment.
• Patients who have been judged clinically to be serious suicidal risks.

Arkansas
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Little Rock,  Arkansas,  United States
California
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Cerritos,  California,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, San Diego,  California,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Vista,  California,  United States
District of Columbia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Washington,  District of Columbia,  United States
Florida
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Jacksonville,  Florida,  United States
Georgia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Atlanta,  Georgia,  United States
Idaho
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Boise,  Idaho,  United States
Louisiana
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Lake Charles,  Louisiana,  United States
Maine
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Bangor,  Maine,  United States
Missouri
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Chesterfield,  Missouri,  United States
Nevada
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Las Vegas,  Nevada,  United States
New Jersey
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Cherry Hill,  New Jersey,  United States
New Mexico
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Albuquerque,  New Mexico,  United States
New York
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, New York,  New York,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Olean,  New York,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Rochester,  New York,  United States
Ohio
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Beachwood,  Ohio,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Cincinnati,  Ohio,  United States
Tennessee
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Madison,  Tennessee,  United States
Texas
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Houston,  Texas,  United States
Washington
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Bellevue,  Washington,  United States
Puerto Rico
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, San Juan,  Puerto Rico
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Rio Piedras,  Puerto Rico
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Cidra,  Puerto Rico

Study ID Numbers:  4360
Record last reviewed:  November 2004
Last Updated:  November 12, 2004
Record first received:  November 26, 2002
ClinicalTrials.gov Identifier:  NCT00050206
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08