Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia
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ClinicalTrials.gov Identifier: NCT00051298 |
Recruitment Status :
Completed
First Posted : January 9, 2003
Last Update Posted : June 12, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Olanzapine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia |
Study Start Date : | November 2002 |
Actual Study Completion Date : | April 2005 |

- Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C
- Assess secondary efficacy measures to capture additional evidence of efficacy utilizing the CGI-I, CGI-S, PANSS and OAS
- Assess the efficacy of olanzapine compared with placebo in improving clinical symptomatology in terms of rate of response
- Assess the safety of olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment.
- Assess the health-related quality of life and cognition associated with olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment.

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Ages Eligible for Study: | 13 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Are male or female patients, 13 to 17 years of age
- Patients must have a diagnosis of schizophrenia per DSM-IV-TR.
- 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.
- Patients must be capable of swallowing study medication whole (without crushing, dissolving, etc.)
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051298
United States, Arkansas | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Little Rock, Arkansas, United States | |
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 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
San Diego, California, United States | |
United States, District of Columbia | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Washington, District of Columbia, United States | |
United States, Florida | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Jacksonville, Florida, United States | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
North Miami, Florida, United States | |
United States, Georgia | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Atlanta, Georgia, United States | |
United States, Illinois | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Chicago, Illinois, United States | |
United States, Indiana | |
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Indianapolis, Indiana, United States | |
United States, Louisiana | |
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Lake Charles, Louisiana, United States | |
United States, Maine | |
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Bangor, Maine, United States | |
United States, Minnesota | |
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Minneapolis, Minnesota, United States | |
United States, Missouri | |
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Chesterfield, Missouri, United States | |
United States, Nevada | |
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Las Vegas, Nevada, United States | |
United States, New Jersey | |
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Cherry Hill, New Jersey, United States | |
United States, New York | |
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New York, New York, United States | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Rochester, New York, United States | |
United States, Ohio | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Beachwood, Ohio, United States | |
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Cincinnati, Ohio, United States | |
United States, Pennsylvania | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Hershey, Pennsylvania, United States | |
United States, Tennessee | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Madison, Tennessee, United States | |
United States, Texas | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Bellaire, Texas, United States | |
United States, Utah | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Salt Lake City, Utah, United States | |
United States, Washington | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Kirkland, Washington, United States | |
Russian Federation | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician. | |
Moscow, Russian Federation |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00051298 |
Other Study ID Numbers: |
4066 F1D-MC-HGIN |
First Posted: | January 9, 2003 Key Record Dates |
Last Update Posted: | June 12, 2007 |
Last Verified: | June 2007 |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |