Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia
NCT ID: NCT00337662
Last Updated: 2010-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
628 participants
INTERVENTIONAL
2006-05-31
2007-12-31
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
QUADRUPLE
Study Groups
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1
Olanzapine for Not Early Onset response (NEO) patients
olanzapine
10-20 milligrams (mg), oral, daily, 10 weeks.
2
Risperidone for Not Early Onset response (NEO) patients
risperidone
2-6 mg, oral, daily, for 10 weeks.
3
Risperidone for Early Onset response (EO) patients
risperidone
2-6 mg, oral, daily, 10 weeks
Interventions
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olanzapine
10-20 milligrams (mg), oral, daily, 10 weeks.
risperidone
2-6 mg, oral, daily, for 10 weeks.
risperidone
2-6 mg, oral, daily, 10 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have experienced an exacerbation of their illness within the previous 2 weeks.
* Patients in whom a switch to another antipsychotic medication is acutely indicated.
Exclusion Criteria
* Patients who have been hospitalized for greater than 2 weeks immediately prior to Visit 1.
* Patients having received olanzapine or risperidone in the past 30 days.
* Treatment with clozapine within 1 year prior to Visit 1.
* Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to Visit 1 (or at any time during the study).
* A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.
18 Years
65 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
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 hours, EST), or speak with your personal physician.
Little Rock, Arkansas, United States
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Escondido, California, United States
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Garden Grove, California, United States
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Glendale, California, United States
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National City, California, United States
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Orange, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Washington D.C., District of Columbia, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Chicago, Illinois, United States
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Paducah, Kentucky, United States
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Lake Charles, Louisiana, United States
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Boston, Massachusetts, United States
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Jackson, Mississippi, United States
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Kansas City, Missouri, United States
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Omaha, Nebraska, United States
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Clementon, New Jersey, United States
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Cedarhurst, New York, United States
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Olean, New York, United States
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Staten Island, New York, United States
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Toledo, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Rapid City, South Dakota, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Arlington, Virginia, United States
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Portsmouth, Virginia, United States
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Richmond, Virginia, United States
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Kirkland, Washington, United States
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Buenos Aires, , Argentina
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Khot'kovo, , Russia
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Moscow, , Russia
Countries
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References
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Chen L, Phillips G, Johnston J, Kinon BJ, Ascher-Svanum H, Kollack-Walker S, Succop P, Naber D. The relationship, structure and profiles of schizophrenia measurements: a post-hoc analysis of the baseline measures from a randomized clinical trial. BMC Psychiatry. 2011 Dec 28;11:203. doi: 10.1186/1471-244X-11-203.
Fijal BA, Stauffer VL, Kinon BJ, Conley RR, Hoffmann VP, Witte MM, Zhao F, Houston JP. Analysis of gene variants previously associated with iloperidone response in patients with schizophrenia who are treated with risperidone. J Clin Psychiatry. 2012 Mar;73(3):367-71. doi: 10.4088/JCP.10m06507. Epub 2011 Jul 12.
Ascher-Svanum H, Nyhuis AW, Stauffer V, Kinon BJ, Faries DE, Phillips GA, Schuh K, Awad AG, Keefe R, Naber D. Reasons for discontinuation and continuation of antipsychotics in the treatment of schizophrenia from patient and clinician perspectives. Curr Med Res Opin. 2010 Oct;26(10):2403-10. doi: 10.1185/03007995.2010.515900.
Kinon BJ, Chen L, Ascher-Svanum H, Stauffer VL, Kollack-Walker S, Zhou W, Kapur S, Kane JM. Early response to antipsychotic drug therapy as a clinical marker of subsequent response in the treatment of schizophrenia. Neuropsychopharmacology. 2010 Jan;35(2):581-90. doi: 10.1038/npp.2009.164.
Other Identifiers
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F1D-US-HGMN
Identifier Type: OTHER
Identifier Source: secondary_id
10769
Identifier Type: -
Identifier Source: org_study_id
NCT00373321
Identifier Type: -
Identifier Source: nct_alias
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