Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00034580
First received: April 30, 2002
Last updated: July 18, 2006
Last verified: July 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034580

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

No publications provided

ClinicalTrials.gov Identifier: NCT00034580     History of Changes
Other Study ID Numbers: 5528, F1D-US-HGJT
Study First Received: April 30, 2002
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Bipolar I Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pathologic Processes
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on October 16, 2014