Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment
NCT ID: NCT00191555
Last Updated: 2012-06-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
360 participants
Study Classification
INTERVENTIONAL
Study Start Date
2003-08-31
Study Completion Date
2006-05-31
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.
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Detailed Description
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Conditions
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Schizophrenia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Interventions
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olanzapine
Intervention Type
DRUG
haloperidol
Intervention Type
DRUG
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.
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.
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Countries
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France
References
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Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.
Reference Type
DERIVED
Other Identifiers
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F1D-FP-S029
Identifier Type: -
Identifier Source: secondary_id
6589
Identifier Type: -
Identifier Source: org_study_id
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