Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia
NCT ID: NCT00051298
Last Updated: 2007-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
107 participants
INTERVENTIONAL
2002-11-30
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Olanzapine
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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Cerritos, California, United States
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San Diego, California, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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North Miami, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Lake Charles, Louisiana, United States
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Bangor, Maine, United States
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Minneapolis, Minnesota, United States
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Chesterfield, Missouri, United States
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Las Vegas, Nevada, United States
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Cherry Hill, New Jersey, United States
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New York, New York, United States
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Rochester, New York, United States
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Hershey, Pennsylvania, United States
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Madison, Tennessee, United States
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Bellaire, Texas, United States
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Salt Lake City, Utah, United States
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Kirkland, Washington, United States
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Moscow, , Russia
Countries
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References
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Kryzhanovskaya LA, Robertson-Plouch CK, Xu W, Carlson JL, Merida KM, Dittmann RW. The safety of olanzapine in adolescents with schizophrenia or bipolar I disorder: a pooled analysis of 4 clinical trials. J Clin Psychiatry. 2009 Feb;70(2):247-58. doi: 10.4088/jcp.08m03538. Epub 2009 Feb 10.
Kryzhanovskaya L, Schulz SC, McDougle C, Frazier J, Dittmann R, Robertson-Plouch C, Bauer T, Xu W, Wang W, Carlson J, Tohen M. Olanzapine versus placebo in adolescents with schizophrenia: a 6-week, randomized, double-blind, placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009 Jan;48(1):60-70. doi: 10.1097/CHI.0b013e3181900404.
Other Identifiers
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F1D-MC-HGIN
Identifier Type: -
Identifier Source: secondary_id
4066
Identifier Type: -
Identifier Source: org_study_id