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Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00034580
Recruitment Status : Completed
First Posted : May 1, 2002
Last Update Posted : July 19, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: olanzapine Drug: risperidone Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed
Study Start Date : August 2001
Study Completion Date : August 2002

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject, 18-70 years of age
  • Female subjects of childbearing potential must be using a medically accepted means of contraception
  • Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
  • Subjects must be considered reliable

Exclusion:

  • Female subjects who are either pregnant or nursing
  • Uncorrected hypothyroidism or hyperthyroidism
  • Narrow-angle glaucoma
  • Subjects who present a serious and immediate risk of endangering him or herself

Information from the National Library of Medicine

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): NCT00034580


Locations
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United States, California
Berkley, California, United States
Los Angeles, California, United States
Orange, California, United States
San Marcos, California, United States
Torrance, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
Middleton, Connecticut, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Winter Park, Florida, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Hoffman Estates, Illinois, United States
United States, Massachusetts
Natick, Massachusetts, United States
United States, Missouri
St Louis, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Clementon, New Jersey, United States
United States, New York
Olean, New York, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Madison, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Virginia
Richmond, Virginia, United States
Roanoke, Virginia, United States
Sponsors and Collaborators
Eli Lilly and Company

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ClinicalTrials.gov Identifier: NCT00034580    
Other Study ID Numbers: 5528
F1D-US-HGJT
First Posted: May 1, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006
Keywords provided by Eli Lilly and Company:
Bipolar I Disorder
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Olanzapine
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators