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Efficacy of High Dose Olanzapine for the Treatment of Schizophrenia and Schizoaffective Disorder - Article


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Olanzapine

Zyprexa; Zyprexa Zydis


Clinical Trial: Efficacy of High Dose Olanzapine for the Treatment of Schizophrenia and Schizoaffective Disorder

This study is currently recruiting patients.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company

Purpose

The purposes of this study are to assess the efficacy, safety, and side effects among doses approved by the Food and Drug Administration and higher (not FDA approved) doses of olanzapine in patients with schizophrenia or schizoaffective disorder.

Condition Treatment or Intervention Phase
Schizophrenia
Schizoaffective Disorder
 Drug: Olanzapine
Phase IV

MedlinePlus related topics:  Mental Health;   Schizophrenia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title: Efficacy of High Dose Olanzapine in a Controlled Fixed Dose-Response Trial for the Treatment of Schizophrenia and Schizoaffective Disorder

Further Study Details: 

Expected Total Enrollment:  600

Study start: September 2003;  Expected completion: April 2005

Eligibility

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • You must be 18 to 60 years old
  • You must have been diagnosed with schizophrenia or schizoaffective disorder
  • You must be able to visit the doctor's office 8 times over a 9 week period
  • You must agree to participate with all tests and examinations that are required for this study

Exclusion Criteria:

  • You are a woman and are pregnant or breastfeeding
  • You presently have an acute or unstable medical illness
  • You have a history of an allergic reaction to olanzapine (Zyprexa)
  • You are taking medications that are not permitted in this study. Your physician will discuss these with you
  • You have taken part in another clinical research trial within the last 30 days or you have received treatment with a drug in the last 30 days that has not received regulatory approval.

Location and Contact Information

"There may be multiple sites in this clinical trial."      1-877-CTLILLY (1-877-285-4559) 

Arkansas
      For additional information regarding investigative sites for this trial, contract (1-877-285-4559) or speak with your personal physician, Little Rock,  Arkansas,  United States; Recruiting

California
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at (1-877-285-4559) or speak with your personal physician.", Chula Vista,  California,  United States; Recruiting

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Connecticut
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District of Columbia
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Florida
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      For additional information regarding investigative sites for this trial, contract (1-877-285-4559) or speak with your personal physician, Winter Park,  Florida,  United States; Recruiting

Georgia
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Illinois
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Indiana
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Maryland
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Michigan
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Minnesota
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Missouri
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Nebraska
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Nevada
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      For additional information regarding investigative sites for this trial, contract (1-877-285-4559) or speak with your personal physician, Reno,  Nevada,  United States; Recruiting

New Jersey
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      For additional information regarding investigative sites for this trial, contract (1-877-285-4559) or speak with your personal physician, Kenilworth,  New Jersey,  United States; Recruiting

New York
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North Carolina
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      For additional information regarding investigative sites for this trial, contract (1-877-285-4559) or speak with your personal physician, Raleigh,  North Carolina,  United States; Recruiting

Ohio
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      For additional information regarding investigative sites for this trial, contract (1-877-285-4559) or speak with your personal physician, Cleveland,  Ohio,  United States; Recruiting

Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
      For additional information regarding investigative sites for this trial, contract (1-877-285-4559) or speak with your personal physician, Tacoma,  Washington,  United States; Recruiting

More Information

Study ID Numbers:  8333
Record last reviewed:  January 2005
Last Updated:  January 7, 2005
Record first received:  January 6, 2005
ClinicalTrials.gov Identifier:  NCT00100776
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: June 1, 2005
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