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Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034580
First Posted: May 1, 2002
Last Update Posted: July 19, 2006
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.
Information provided by:
Eli Lilly and Company
  Purpose
This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.

Condition Intervention Phase
Bipolar Disorder Drug: olanzapine Drug: risperidone Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Estimated Enrollment: 326
Study Start Date: August 2001
Estimated Study Completion Date: August 2002
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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


  Show 21 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
  More Information

ClinicalTrials.gov Identifier: NCT00034580     History of Changes
Other Study ID Numbers: 5528
F1D-US-HGJT
First Submitted: April 30, 2002
First Posted: May 1, 2002
Last Update Posted: July 19, 2006
Last Verified: July 2006

Keywords provided by Eli Lilly and Company:
Bipolar I Disorder

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Risperidone
Olanzapine
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