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

• Status: Completed
• Trial end date: 1991-12-01
• 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 a fixed 10-mg 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:

• 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 Criteria:

• 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.