Back to resultsZotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Zotepine
Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, zotepine, risperidone, second generation antipsychotic
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1. Zotepine
2. Risperidone
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.
Secondary Outcome Measures
Change from baseline on the total score of Positive and Negative Syndrome Scale
Change from baseline on Clinical Global Impression (CGI)
Full Information
NCT ID
NCT00418873
First Posted
January 3, 2007
Last Updated
April 15, 2010
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Taiwan, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00418873
Brief Title
Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
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 Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to difficulty in patient enrollment
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Taiwan, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, zotepine, risperidone, second generation antipsychotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Zotepine
Arm Type
Experimental
Arm Title
2. Risperidone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zotepine
Other Intervention Name(s)
Lodopin®, Zoleptil®, Nipolept®
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal®
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Change from baseline on the total score of Positive and Negative Syndrome Scale
Time Frame
6 Weeks
Title
Change from baseline on Clinical Global Impression (CGI)
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Jer Tsai
Organizational Affiliation
Taipei City Hospital
Official's Role
Principal Investigator
Facility Information:
City
Bali
State/Province
Taipei county
ZIP/Postal Code
249
Country
Taiwan
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
330
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24100785
Citation
Chan HY, Lin AS, Chen KP, Cheng JS, Chen YY, Tsai CJ. An open-label, randomized, controlled trial of zotepine and risperidone for acutely ill, hospitalized, schizophrenic patients with symptoms of agitation. J Clin Psychopharmacol. 2013 Dec;33(6):747-52. doi: 10.1097/JCP.0b013e31829e8168.
Results Reference
derived
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Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
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