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Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00418873
Recruitment Status : Terminated (Study was stopped due to difficulty in patient enrollment)
First Posted : January 5, 2007
Last Update Posted : April 16, 2010
Astellas Pharma Taiwan, Inc.
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Zotepine Drug: Risperidone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2007
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1. Zotepine Drug: Zotepine
Other Names:
  • Lodopin®
  • Zoleptil®
  • Nipolept®
Active Comparator: 2. Risperidone Drug: Risperidone
Other Name: Risperdal®

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

Secondary Outcome Measures :
  1. Change from baseline on the total score of Positive and Negative Syndrome Scale [ Time Frame: 6 Weeks ]
  2. Change from baseline on Clinical Global Impression (CGI) [ Time Frame: 6 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418873

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

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
First Posted: January 5, 2007    Key Record Dates
Last Update Posted: April 16, 2010
Last Verified: April 2010

Keywords provided by Astellas Pharma Inc:
second generation antipsychotic

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents