Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Taiwan, Inc.
• Treatments: Risperidone; Zotepine

Criteria

Inclusion Criteria:

• Aged 18 to 65 years, male or female

• In-patients suffering from schizophrenia according to DSM-IV diagnostic criteria with PANSS total score of greater than or equal to 60.

• Patients with PANSS-EC total score of greater than or equal to 14 and with at least one PANSS-EC symptom score greater than or equal to 4

Exclusion Criteria:

• Patients with history of seizure or with alcohol or substance abuse in the last 6 months

• Diabetes, Parkinson's disease or phaeochromocytoma

• Patients with hypertension and current use of antihypertensive agents

• Women who are pregnant, lactating or intend to become pregnant during the study period

• Poor response to two different antipsychotics in full dose and full course or use of clozapine previously

• Renal, hepatic, haematologic disease or other conditions may not suitable for the study based on investigator's evaluation