Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Overview

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

Full Title of Study: “A Multi-centre Comparative Study to Evaluate the Anti-aggression Effect and Safety of Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: December 2009

Interventions

• Drug: Zotepine
  • Oral
• Drug: Risperidone
  • Oral

Arms, Groups and Cohorts

• Experimental: 1. Zotepine
• Active Comparator: 2. Risperidone

Clinical Trial Outcome Measures

Primary Measures

• Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.
  • Time Frame: 6 Weeks

Secondary Measures

• Change from baseline on the total score of Positive and Negative Syndrome Scale
  • Time Frame: 6 Weeks
• Change from baseline on Clinical Global Impression (CGI)
  • Time Frame: 6 Weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Astellas Pharma Inc
• Collaborator
  • Astellas Pharma Taiwan, Inc.
• Provider of Information About this Clinical Study
  • Director, Astellas Pharma Inc.
• Overall Official(s)
  • Chang-Jer Tsai, Principal Investigator, Taipei City Hospital