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 schizophrenia in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.

Condition	Treatment or Intervention	Phase
Schizophrenia	Drug: Olanzapine	Phase IV

Further Study Details: 

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

Criteria

Inclusion Criteria:

• Are male or female patients, 13 to 17 years of age
• Patients must have a diagnosis of schizophrenia.
• Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment.
• 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.

Exclusion Criteria:

• Female patients who are either pregnant or nursing.
• Patients with acute or unstable medical conditions.
• Patients who have been judged clinically to be at serious suicidal risks.
• Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
• Patients who currently have delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder or major depressive disorder.

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, 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, Cerritos,  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
      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., North Miami,  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
Illinois
      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, Chicago,  Illinois,  United States
Indiana
      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, Indianapolis,  Indiana,  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
Minnesota
      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, Minneapolis,  Minnesota,  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 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, 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
Pennsylvania
      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, Hershey,  Pennsylvania,  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, Bellaire,  Texas,  United States
Utah
      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, Salt Lake City,  Utah,  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, Kirkland,  Washington,  United States
Russian Federation
      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, Moscow,  Russian Federation

Study ID Numbers:  4066
Record last reviewed:  March 2004
Last Updated:  October 21, 2004
Record first received:  January 7, 2003
ClinicalTrials.gov Identifier:  NCT00051298
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08