A Comparison of Risperidone With Haloperidol in Patients With Schizophrenia and Schizoaffective Disorder

• Status: Completed
• Trial end date: 1998-09-01
• Target enrollment: 0
• Participant gender: All

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 year.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen, LP
• Treatments: Haloperidol; Haloperidol decanoate; Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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