NCT00036088

Brief Summary

The purpose of this study is to determine how Olanzapine compares to an active comparator in the treatment of schizophrenia

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Aug 2001

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
12 countries

60 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2002

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
Last Updated

July 19, 2006

Status Verified

July 1, 2006

First QC Date

May 7, 2002

Last Update Submit

July 18, 2006

Conditions

Interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • You must be between the ages of 18 and 75. If you have reached your 76th birthday, you will not be able to participate
  • You must have been diagnosed with schizophrenia
  • You must be able to visit the doctor's office as scheduled for the next 7 months

You may not qualify if:

  • You have a serious medical illness, such as heart, liver, or kidney disease (Note: If you are uncertain about a particular condition, discuss it with your doctor.)
  • You are either pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (60)

Unknown Facility

El Centro, California, United States

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Glendale, California, United States

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Sherman Oaks, California, United States

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Middleton, Connecticut, United States

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Norwich, Connecticut, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Hoffman Estates, Illinois, United States

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Lafayette, Indiana, United States

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Rockville, Maryland, United States

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Newton, Massachusetts, United States

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Saint Charles, Missouri, United States

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New York, New York, United States

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Olean, New York, United States

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Staten Island, New York, United States

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Cincinnati, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, 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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Terrell, Texas, United States

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Richmond, Virginia, United States

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La Plata, Buenos Aires, Argentina

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Godoy Cruz, Mendoza Province, Argentina

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Buenos Aires, Argentina

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Ciudad de Buenos Air, Argentina

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Graz, Austria

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Innsbruck, Austria

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Linz, Austria

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Wein, Austria

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Wels, Austria

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Salvador, Estado de Bahia, Brazil

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Aparecida de Goiânia, Goiás, Brazil

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Pelotas, Rio Grande do Sul, Brazil

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Sau Paulo, Sau Paulo, Brazil

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Rio de Janeiro, Brazil

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Essen, Germany

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Hamburg, Germany

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Tübingen, Germany

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Dublin, Ireland

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Mexico City, Mexico

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Lima, Peru

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Cidra, Puerto Rico

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Ponce, Puerto Rico

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Rio Piedras, Puerto Rico

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San Juan, Puerto Rico

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Barcelona, Barcelona, Spain

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San Boi de Llobregat, Barcelona, Spain

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Elizondo, Navarre, Spain

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Pamplona, Navarre, Spain

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Langreo, Principality of Asturias, Spain

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Camberwell, London, United Kingdom

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London, London, United Kingdom

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Kings Lynn, Norfolk, United Kingdom

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Paisley, Scotland, United Kingdom

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Guildford, Surrey, United Kingdom

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Caracas, Venezuela

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Related Publications (1)

  • Liu-Seifert H, Ascher-Svanum H, Osuntokun O, Jen KY, Gomez JC. Change in level of productivity in the treatment of schizophrenia with olanzapine or other antipsychotics. BMC Psychiatry. 2011 May 17;11:87. doi: 10.1186/1471-244X-11-87.

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2002

First Posted

May 8, 2002

Study Start

August 1, 2001

Study Completion

July 1, 2002

Last Updated

July 19, 2006

Record last verified: 2006-07

Locations