Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol in Patients With Chronic Schizophrenia
Lead Sponsor:
Janssen, LP
Conditions:
Schizophrenia
Psychotic Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of different doses of risperidone (an antipsychotic medication) compared with a fixed 10-mg dose of a standard antipsychotic, halop...
Detailed Description
Chronic schizophrenia is a longer-term condition that is characterized by a lack of drive, underactivity and slowness, and social withdrawal. As with the acute form of schizophrenia, delusions and hal...
Eligibility Criteria
Inclusion
- Diagnosis of chronic schizophrenic disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 3rd edition (DSM-III-R) criteria
- total score on the PANSS at study entry of \>=60 and \<=120
- physical and neurological examination and ECG findings and clinical hematology, biochemistry, and urinalysis test results within normal limits before study entry
- patients must be able to be hospitalized the first 3 weeks of the study, if possible.
Exclusion
- Patients with mental disorders other than chronic schizophrenic disorder
- patients with clinically significant organic or neurologic diseases
- women who are pregnant or breastfeeding, and women of childbearing potential without adequate birth control measures
- patients with epilepsy
- history of alcohol or drug abuse history within the previous 12 months.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1991
Estimated Enrollment :
1579 Patients enrolled
Trial Details
Trial ID
NCT00249119
End Date
December 1 1991
Last Update
February 11 2011
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