A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol and Placebo in Patients With Chronic Schizophrenia

• Status: Completed
• Trial end date: 1991-07-01
• Target enrollment: 0
• Participant gender: All

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 antipsychotic, haloperidol, in patients with chronic schizophrenia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.