Back to resultsThe New Strategy for Pharmacological Treatment in People With Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rispridoen and Aripiprazole
Risperidne
Abilify
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Switching, Early stage, Risperidone, Aripirazole
Eligibility Criteria
Inclusion Criteria: Schizophrenia, DSM-IV Acute phase Exclusion Criteria: Refractory Schizophrenia Substance Abuse High risk for suicide
Sites / Locations
- Dongrae HospitalRecruiting
- Dongseo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Aripiprazole
Risperidone
Abilify
Arm Description
switching group (from risperidone to aripiprazole)
Start with risperidone and keep it through the end of study
Start with aripiprazole and keep it through the end of study
Outcomes
Primary Outcome Measures
SANS(Scale for the Assessment of Negative Symptoms)
Secondary Outcome Measures
SARS(Simpson-Angus Rating Scale)
Drug Attitude Inventory
Side effect checklist
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00352339
Brief Title
The New Strategy for Pharmacological Treatment in People With Schizophrenia
Official Title
Switch Risperidone to Aripiprazole in Early Stage of Pharmacotherapy of Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Inje University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate the same efficacy as compared to risperidone continuation treatment in the treatment of schizophrenia.
Detailed Description
It has been thought that D2 Blocking agent is necessary in acute as well as maintenance phase of pharmacological treatment of patients with schizophrenia. However, this classical strategy produces long term adverse events of drug such as TD, osteoporosis and some metabolic syndrome. To overcome these adverse events, new strategy for pharmacological treatment is needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Switching, Early stage, Risperidone, Aripirazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
switching group (from risperidone to aripiprazole)
Arm Title
Risperidone
Arm Type
Active Comparator
Arm Description
Start with risperidone and keep it through the end of study
Arm Title
Abilify
Arm Type
Active Comparator
Arm Description
Start with aripiprazole and keep it through the end of study
Intervention Type
Drug
Intervention Name(s)
Rispridoen and Aripiprazole
Intervention Description
Start with risperidone and switch it to aripiprazole. Flexible dose
Intervention Type
Drug
Intervention Name(s)
Risperidne
Intervention Description
Start with risperidne and keep it through the end of study. Risperidne:flexible dose
Intervention Type
Drug
Intervention Name(s)
Abilify
Other Intervention Name(s)
abilify is a generic name of aripiprazole
Intervention Description
Start with abilify and keep it through the end of study
Primary Outcome Measure Information:
Title
SANS(Scale for the Assessment of Negative Symptoms)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
SARS(Simpson-Angus Rating Scale)
Time Frame
12 weeks
Title
Drug Attitude Inventory
Time Frame
12 weeks
Title
Side effect checklist
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Schizophrenia, DSM-IV
Acute phase
Exclusion Criteria:
Refractory Schizophrenia
Substance Abuse
High risk for suicide
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun-A Lee, MS
Phone
82-51-890-8955
Email
euna066@nate.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Cheol Shim, MD,PhD
Organizational Affiliation
Clinical Trial Center, Paik hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongrae Hospital
City
Busan
ZIP/Postal Code
609-370
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung-Soo Seo, MD.PhD
Phone
82-51-508-0011
Email
npsys@hanmail.net
First Name & Middle Initial & Last Name & Degree
Young-Soo Seo, MD.PhD
Facility Name
Dongseo Hospital
City
Masan
ZIP/Postal Code
630-856
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do-Un Jung, MD
Phone
82-016-579-2985
Email
cgabriel@chol.com
First Name & Middle Initial & Last Name & Degree
Do-Un Jung, MD
12. IPD Sharing Statement
Learn more about this trial
The New Strategy for Pharmacological Treatment in People With Schizophrenia
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