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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: olanzapine; Drug: haloperidol

• Study Type: Interventional
• Enrollment: 360
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France
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  • Alencon, France
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  • Alise sainte reine, France
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  • Amilly, France
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  • Aubergenville, France
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  • Barbazan Debat, France
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  • Bohars, France
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  • Bordeaux, France
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  • Bourges, France
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  • Bron, France
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  • Brumath, France
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  • Castres, France
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  • Challans, France
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  • Chateau Gontier, France
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  • Chaumont, France
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  • Cluses, France
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  • Decize, France
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  • Dijon, France
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  • Dole, France
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  • Figeac, France
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  • Fontaines, France
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  • Graulhet, France
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  • Henin-Beaumont, France
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  • L'Aigle, France
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  • La Roche sur Foron, France
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  • La Rochelle, France
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  • La Seyne sur Mer, France
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  • Limoges, France
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  • Longuic, France
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  • Mably, France
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  • Marseille, France
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  • Melun, France
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  • Metz, France
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  • Mont Saint Martin, France
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  • Monteleger, France
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  • Montfavet, France
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  • Montpellier, France
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  • Mulhouse, France
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  • Nancy, France
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  • Narbonne, France
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  • Nevers, France
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  • Niort, France
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  • Paris, France
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  • Plaisir, France
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  • Poitiers, France
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  • Pont a Mousson, France
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  • Reims, France
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  • Saint Cyr au Mont d'Or, France
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  • Saint Julien en Genevois, France
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  • Saint-Egreve, France
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  • Saint-Malo, France
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  • Saint-Nazaire, France
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  • Sete, 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
  • Sin-Le-Noble, France
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  • Strasbourg, 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
  • Tarbes, France
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  • Torcy, France
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  • Toulon, France
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  • Toulouse, France
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  • Vaulx en Velin, France
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  • Viersat, France
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  • Villejuif, France
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy measure is defined as relapse. Relapse is defined by the presence of at least one of the following criteria:
Psychiatric hospitalization.
A 25% increase in the total score on the PANSS scale (Kay SR et al. 1987) in relation to the score obtained at the baseline visit (Visit 2).
A major deterioration in clinical condition, defined by a score of 6 ("much worse") or 7 ("very much worse") on the CGI-I scale (Clinical Global Impression-Improvement)
Suicide attempt requiring medical treatment and/or jeopardizing vital prognosis (self-mutilation, ingestion of a toxic substance, defenestration, self-mutilation with suicidal intent).

Secondary Outcome Measures

Outcome Measure
The following secondary efficacy criteria will be measured at the times indicated in the Schedule of Events
Positive and negative symptom scale : PANSS
Clinical global impression scale: CGI [Clinical global impression-severity of illness (CGI-S); Clinical global impression-improvement of illness (CGI-I); Clinical Global Impression scale - Psychic distress]
Schizophrenic Communication Disorder Rating Scale: SCD
Social Interactions measurement tools
Intention Reading Task in a real-life situation
Patient Outcome based on Preference Tool: POP
Patient's quality of life: S-QOL

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Study Completion: May 1, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): June 12, 2012
• Last Update Submitted That Met QC Criteria: June 8, 2012
• Last Verified: July 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Dopamine Agents; Dopamine Antagonists; Anti-Dyskinesia Agents; Olanzapine; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: 6589; F1D-FP-S029