Schizophrenia
Conditions
Keywords
schizophrenia, zotepine, risperidone, second generation antipsychotic
Brief summary
The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.
Interventions
DRUGZotepine
Oral
DRUGRisperidone
Oral
Sponsors
Astellas Pharma Taiwan, Inc.
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score. | 6 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed