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

NCT ID: NCT00034801

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

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2003-03-31

Brief Summary

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This is a research study comparing the safety and efficacy of two active study medications

Detailed Description

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Conditions

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Depression Schizophrenia Schizoaffective Disorder

Keywords

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Depression Comorbid Depression Schizophrenia Schizoaffective 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

ziprasidone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Tuscaloosa, Alabama, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Anaheim, California, United States

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Chula Vista, California, United States

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Lafayette, California, United States

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Long Beach, California, United States

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Orange, California, United States

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Poway, California, United States

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Rosemeade, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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New Britain, Connecticut, United States

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Winter Park, Florida, United States

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Augusta, Georgia, United States

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Prairie Village, Kansas, United States

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Gaithersburg, Maryland, United States

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Mount Pleasant, Michigan, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Clementon, New Jersey, United States

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Buffalo, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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Charlotte, North Carolina, United States

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Philadelphia, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Austin, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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F1D-US-HGJU

Identifier Type: -

Identifier Source: secondary_id

5529

Identifier Type: -

Identifier Source: org_study_id