Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
- Registration Number
- NCT00418873
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 39
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1. Zotepine Zotepine - 2. Risperidone Risperidone -
- Primary Outcome Measures
Name Time Method Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score. 6 Weeks
- Secondary Outcome Measures
Name Time Method 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