Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Verified by: Astellas Pharma Inc, April 2010
First Received: January 3, 2007 | Last Updated: April 15, 2010 | Phase: Phase 4 | Start Date: March 2007
Overall Status: Terminated | Estimated Enrollment: 39
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The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation 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 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

Clinical Trial Investigator Information

Lead Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Chang-Jer Tsai Principal Investigator Taipei City Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00418873