Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

This study has been completed.

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00034580

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 IV

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Risperidone Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed

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

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

Show 21 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

More Information

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

Keywords provided by Eli Lilly and Company:

Bipolar I Disorder

Study placed in the following topic categories:

Affective Disorders, Psychotic
Dopamine
Mental Disorders
Bipolar Disorder
Risperidone

Olanzapine
Mood Disorders
Psychotic Disorders
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009