Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Zotepine (Drug); Risperidone (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Chang-Jer Tsai, Principal Investigator, Affiliation: Taipei City Hospital
Summary
The purpose of this study is to compare the efficacy and tolerability of zotepine versus
Risperidone in aggressive schizophrenic patients.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.
Secondary outcome: Change from baseline on the total score of Positive and Negative Syndrome ScaleChange from baseline on Clinical Global Impression (CGI)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Taipei 110, Taiwan
Taipei 114, Taiwan
Taoyuan 330, Taiwan
Bali, Taipei county 249, Taiwan
Additional Information
Starting date: March 2007
Last updated: April 15, 2010
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