Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia

Depression Clinical Trial

Official title:

A Controlled Trial of Olanzapine Versus Active Comparator in the Treatment of Schizophrenic and Schizoaffective Subjects With Comorbid Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034801
• Other study ID #: 5529
• Secondary ID: F1D-US-HGJU
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2002
• Last updated: July 18, 2006
• Start date: September 2001
• Est. completion date: March 2003

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male or female subjects 18-60 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 Criteria:

• Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry

• Female subjects who are either pregnant or nursing

• Uncorrected hypothyroidism or hyperthyroidism

• Narrow-angle glaucoma

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• olanzapine

• ziprasidone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States,