An open-label, randomized, controlled trial of zotepine and risperidone for acutely ill, hospitalized, schizophrenic patients with symptoms of agitation.
Hung-Yu Chan, An-Sheng Lin, Kun-Po Chen...
https://pubmed.ncbi.nlm.nih.gov/24100785Terminated
Phase 4
Age: 18Years - 65Years
All Genders
ID00418873
A Multi-centre Comparative Study to Evaluate the Anti-aggression Effect and Safety of Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
Led by Astellas Pharma Inc · Updated on 2010-04-16
39
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Astellas Pharma Inc
Lead Sponsor
A
Astellas Pharma Taiwan, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.
CONDITIONS
Brief Title
Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
Trial Site Locations
Total: 4 locations
1
Bali, Taipei, Taiwan, 249
Status Unknown
2
Taipei, Taiwan, 110
Status Unknown
3
Taipei, Taiwan, 114
Status Unknown
4
Taoyuan, Taiwan, 330
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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