Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT00418873

Collaborator

Astellas Pharma Taiwan, Inc. (Industry)

Enrollment

Locations

Arms

33.1

Duration (Months)

9.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Mar 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1. Zotepine

Drug: Zotepine

Oral

Other Names:

Lodopin®

Zoleptil®

Nipolept®

Active Comparator: 2. Risperidone

Drug: Risperidone

Oral

Other Names:

Risperdal®

Outcome Measures

Primary Outcome Measures

Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score. [6 Weeks]

Secondary Outcome Measures

Change from baseline on the total score of Positive and Negative Syndrome Scale [6 Weeks]
Change from baseline on Clinical Global Impression (CGI) [6 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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