Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

April 15, 2010 updated by: Astellas Pharma Inc

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
      • Taipei, Taiwan, 110
      • Taoyuan, Taiwan, 330
    • Taipei county
      • Bali, Taipei county, Taiwan, 249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. Zotepine
Drug: Zotepine
Oral
Other Names:
  • Lodopin®
  • Zoleptil®
  • Nipolept®
Active Comparator: 2. Risperidone
Drug: Risperidone
Oral
Other Names:
  • Risperdal®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Taiwan, Inc.

Investigators

  • Principal Investigator: Chang-Jer Tsai, Taipei City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 5, 2007

Study Record Updates

Last Update Posted (Estimate)

April 16, 2010

Last Update Submitted That Met QC Criteria

April 15, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPRIS-0601-TW

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Zotepine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe