Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

This study has been completed.

First Received on April 30, 2002. Last Updated on July 18, 2006 History of Changes

Sponsor:	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

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:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Risperidone Olanzapine

U.S. FDA Resources

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

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
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Risperidone
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents

Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 12, 2012