Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034580
• Other study ID #: 5528
• Secondary ID: F1D-US-HGJT
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2002
• Last updated: July 18, 2006
• Start date: August 2001
• Est. completion date: August 2002

Study information

• Verified date: July 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• olanzapine

• risperidone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States,