Status:
COMPLETED
A Comparison of Risperidone With Haloperidol in Patients With Schizophrenia and Schizoaffective Disorder
Lead Sponsor:
Janssen, LP
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to compare the time to relapse in patients with schizophrenia and schizoaffective disorders receiving risperidone or haloperidol (antipsychotic medications) for at least 1 ...
Detailed Description
Schizophrenia is a severe mental illness that causes changes in a person's perception, thoughts, and behaviour. In schizophrenics, the most common symptoms are positive symptoms (delusions and halluci...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) criteria
- documented 1-year history of schizophrenia or schizoaffective disorder since the first drug treatment for psychotic symptoms
- history within the previous 24 months of being discharged from an inpatient psychiatric unit, had a partial hospitalization, completed crisis management intervention, or stayed in a hospital emergency room holding area for at least 12 hours
- must have received a stable dose of an antipsychotic medication for the 30 days before study entry
- in the investigator's judgment, must be able to discontinue any current antipsychotic medication.
Exclusion
- Patients with clinically significant neurological disorders, with the exception of DSM-IV defined movement disorders that are caused by drugs
- patients with another current DSM-IV Axis I diagnosis (except nicotine or caffeine dependence)
- history or current diagnosis of gastrointestinal, liver, or kidney disease or other condition that might interfere with how the study drug is absorbed, processed, and excreted by the body
- pregnant or nursing women
Key Trial Info
Start Date :
May 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1998
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT00253110
Start Date
May 1 1996
End Date
September 1 1998
Last Update
August 6 2012
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