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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
olanzapine
haloperidol
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 12, 2005
Last Updated
June 8, 2012
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00191555
Brief Title
Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment
Official Title
Double-Blind Long-term Study Comparing the Efficacy and Safety of Olanzapine Versus Haloperidol in Patients With Schizophrenia Previously Stabilized With Conventional Antipsychotic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
360 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Type
Drug
Intervention Name(s)
haloperidol
Primary Outcome Measure Information:
Title
The primary efficacy measure is defined as relapse. Relapse is defined by the presence of at least one of the following criteria:
Title
Psychiatric hospitalization.
Title
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).
Title
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)
Title
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 Measure Information:
Title
The following secondary efficacy criteria will be measured at the times indicated in the Schedule of Events
Title
Positive and negative symptom scale : PANSS
Title
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]
Title
Schizophrenic Communication Disorder Rating Scale: SCD
Title
Social Interactions measurement tools
Title
Intention Reading Task in a real-life situation
Title
Patient Outcome based on Preference Tool: POP
Title
Patient's quality of life: S-QOL

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
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Aix en Provence
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France
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France
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France
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L'Aigle
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France
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Limoges
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Mont Saint Martin
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France
Facility Name
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
City
Monteleger
Country
France
Facility Name
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
City
Montfavet
Country
France
Facility Name
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
City
Montpellier
Country
France
Facility Name
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
City
Mulhouse
Country
France
Facility Name
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
City
Nancy
Country
France
Facility Name
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
City
Narbonne
Country
France
Facility Name
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
City
Nevers
Country
France
Facility Name
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
City
Niort
Country
France
Facility Name
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
City
Paris
Country
France
Facility Name
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
City
Plaisir
Country
France
Facility Name
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
City
Poitiers
Country
France
Facility Name
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
City
Pont a Mousson
Country
France
Facility Name
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
City
Reims
Country
France
Facility Name
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
City
Saint Cyr au Mont d'Or
Country
France
Facility Name
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
City
Saint Julien en Genevois
Country
France
Facility Name
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
City
Saint-Egreve
Country
France
Facility Name
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
City
Saint-Malo
Country
France
Facility Name
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
City
Saint-Nazaire
Country
France
Facility Name
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
City
Sete
Country
France
Facility Name
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
City
Sin-Le-Noble
Country
France
Facility Name
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
City
Strasbourg
Country
France
Facility Name
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
City
Tarbes
Country
France
Facility Name
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
City
Torcy
Country
France
Facility Name
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
City
Toulon
Country
France
Facility Name
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
City
Toulouse
Country
France
Facility Name
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
City
Vaulx en Velin
Country
France
Facility Name
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
City
Viersat
Country
France
Facility Name
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
City
Villejuif
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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