Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

July 18, 2006 updated by: Eli Lilly and Company

Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

326

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkley, California, United States
      • Los Angeles, California, United States
      • Orange, California, United States
      • San Marcos, California, United States
      • Torrance, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Middleton, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Winter Park, Florida, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Hoffman Estates, Illinois, United States
    • Massachusetts
      • Natick, Massachusetts, United States
    • Missouri
      • St Louis, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Clementon, New Jersey, United States
    • New York
      • Olean, New York, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Madison, Tennessee, United States
    • Texas
      • Houston, Texas, United States
    • Virginia
      • Richmond, Virginia, United States
      • Roanoke, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion

August 1, 2002

Study Registration Dates

First Submitted

April 30, 2002

First Submitted That Met QC Criteria

April 30, 2002

First Posted (Estimate)

May 1, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5528
  • F1D-US-HGJT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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