Status:
TERMINATED
Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Taiwan, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.
Eligibility 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00418873
Start Date
March 1 2007
End Date
December 1 2009
Last Update
April 16 2010
Active Locations (4)
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1
Bali, Taipei, Taiwan, 249
2
Taipei, Taiwan, 110
3
Taipei, Taiwan, 114
4
Taoyuan District, Taiwan, 330