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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

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
    Safety Issue?: No

Secondary Measures

• Change from baseline on the total score of Positive and Negative Syndrome Scale
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Change from baseline on Clinical Global Impression (CGI)
  • Time Frame: 6 Weeks
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Chang-Jer Tsai Principal Investigator Taipei City Hospital  

Overall Contact: Drug Regulatory and Department, Astellas Pharma Taiwan, Inc. +886-2-2507-5799 alice.lin@tw.astellas.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00418873

Study ID Number: LPRIS-0601-TW

ClinicalTrials.gov Identifier: NCT00418873

Health Authority: Taiwan: Department of Health