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Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment | Clinical Trials | Clareo Health

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Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment

Double-Blind Long-term Study Comparing the Efficacy and Safety of Olanzapine Versus Haloperidol in Patients With Schizophrenia Previously Stabilized With Conventional Antipsychotic Treatment

NCT00191555•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The objective of this study is to demonstrate that there is a benefit in switching chronic schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy, neurological safety and patient's outcome.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Schizophrenic patient meeting the DSM-IV diagnostic criteria more than one year ago and treated with antipsychotic for at least 1 year.
•Outpatient (or patient admitted to hospital for social or logistic reasons).
•Patient receiving a stable dose of the same conventional antipsychotic for at least 8 weeks before visit 1.
•Patient presenting a PANSS score equal or greater than 49 at Visit 2.
•Patient considered by the investigator as possible candidates for a switch, owing to inadequate efficacy or poor safety of the current treatment.

Exclusion Criteria

•Patient presenting a schizophreniform or a schizo-affective disorder according to the DSM-IV diagnostic criteria, or any other disorder from Axis I of the DSM-IV, or a disorder from Axis II (limit personality), substance dependence or substance abuse.
•Administration of an atypical antipsychotic drug during the 8 weeks preceding V1.
•History of resistance to antipsychotic drugs
•Hospitalization in a psychiatric unit or in a psychiatric emergency department within the 8 weeks preceding the beginning of the study.
•Presence of serious unstable disease, such as a fatal outcome or hospitalization in an intensive care unit, is foreseeable within a period of 6 months.

Locations (62)

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician

Aix-en-Provence, France

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician

Alençon, France

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician

Alise-Sainte-Reine, France

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician

Amilly, France

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician

Aubergenville, France

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician

Barbazan-Debat, France

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician

Bohars, France

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician

Bordeaux, France

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician

Bourges, France

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) , or speak with your personal physician

Bron, France

Key Dates

Start Date

August 1, 2003

Completion Date

May 1, 2006

Last Updated

June 12, 2012

Enrollment

360

Estimated participants

Conditions

Schizophrenia

Interventions

olanzapine

DRUG

haloperidol

DRUG

Sponsors

Lead Sponsor

Eli Lilly and Company

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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