Status:
COMPLETED
A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol and Placebo in Patients With Chronic Schizophrenia
Lead Sponsor:
Janssen, LP
Conditions:
Schizophrenia
Psychotic Disorders
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 placebo and with a fixed 20 mg/day dose of a standard...
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
- Patients with diagnosis of chronic schizophrenic disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 3rd edition (DSM-III-R) criteria and are inpatients at the beginning of study
- total score on the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) rating scale at study entry of \>=60 and \<=120
- females of childbearing age must demonstrate adequate birth control measures and have a negative pregnancy test before study entry.
Exclusion
- Patients with mental disorders other than chronic schizophrenic disorder
- patients with clinically significant organic or neurological diseases
- patients with epilepsy
- history of alcohol or drug abuse history within the 6 months before study entry.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1991
Estimated Enrollment :
523 Patients enrolled
Trial Details
Trial ID
NCT00249132
End Date
July 1 1991
Last Update
February 11 2011
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