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

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: olanzapine
* Drug: haloperidol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: olanzapine|nan|
|Drug: haloperidol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |