Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

NCT ID: NCT00034580

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2002-08-31

Brief Summary

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

Detailed Description

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Conditions

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Bipolar Disorder

Keywords

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Bipolar I Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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olanzapine

Intervention Type DRUG

risperidone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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Berkley, California, United States

Site Status

Los Angeles, California, United States

Site Status

Orange, California, United States

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San Marcos, California, United States

Site Status

Torrance, California, United States

Site Status

Denver, Colorado, United States

Site Status

Middleton, Connecticut, United States

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Washington D.C., District of Columbia, United States

Site Status

Winter Park, Florida, United States

Site Status

Boise, Idaho, United States

Site Status

Hoffman Estates, Illinois, United States

Site Status

Natick, Massachusetts, United States

Site Status

St Louis, Missouri, United States

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Las Vegas, Nevada, United States

Site Status

Clementon, New Jersey, United States

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Olean, New York, United States

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Philadelphia, Pennsylvania, United States

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Madison, Tennessee, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

Site Status

Roanoke, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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F1D-US-HGJT

Identifier Type: -

Identifier Source: secondary_id

5528

Identifier Type: -

Identifier Source: org_study_id