Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

This study has been terminated.
(Study was stopped due to difficulty in patient enrollment)
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00418873
First received: January 3, 2007
Last updated: April 15, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Zotepine
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score. [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline on the total score of Positive and Negative Syndrome Scale [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline on Clinical Global Impression (CGI) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: March 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Zotepine Drug: Zotepine
Oral
Other Names:
  • Lodopin®
  • Zoleptil®
  • Nipolept®
Active Comparator: 2. Risperidone Drug: Risperidone
Oral
Other Name: Risperdal®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418873

Locations
Taiwan
Bali, Taipei county, Taiwan, 249
Taipei, Taiwan, 110
Taipei, Taiwan, 114
Taoyuan, Taiwan, 330
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Investigators
Principal Investigator: Chang-Jer Tsai Taipei City Hospital
  More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00418873     History of Changes
Other Study ID Numbers: LPRIS-0601-TW
Study First Received: January 3, 2007
Last Updated: April 15, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Astellas Pharma Inc:
schizophrenia
zotepine
risperidone
second generation antipsychotic

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Zotepine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 28, 2014