A Study of the Efficacy and Safety of Long-acting Injectable Risperidone and Risperidone Tablets in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of risperidone, formulated as a long-acting injectable drug, compared with risperidone tablets in the treatment of patients with schizophrenia.

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

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia by the criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th Edition (DSM-IV )

• treatment with an antipsychotic drug (up to 6 milligrams/day of risperidone or equivalent dose) for 28 days before study initiation with no change in the dosage

• Total Positive and Negative Syndrome Scale (PANSS) score >=60 and <120 at start of study.

Exclusion Criteria:

• Diagnosis of mental disease other than schizophrenia

• treated with a sustained-release injection of other antipsychotic medications within 60 days before the initiation of the study

• history of cerebrovascular accident, convulsive disorder such as epilepsy, diabetes mellitus, liver disease, kidney disease, cardiovascular disorder, malignancy or physical exhaustion due to dehydration or malnutrition

• have risk factors of diabetes mellitus, such as hyperglycemia.