Back to resultsEfficacy and Safety of Paliperidone ER in First Episode Psychosis
Primary Purpose
First Episode Psychosis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
paliperidone ER
Sponsored by
About this trial
This is an interventional treatment trial for First Episode Psychosis
Eligibility Criteria
Inclusion Criteria:
- Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.
Exclusion Criteria:
- Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence
- Needing another nonantipsychotic psychotropic medication at enrollment
- Having a serious or unstable medical illness.
- Pregnant or lactating women or women without adequate contraception will be also excluded.
Sites / Locations
- Department of Psychiatry, Korea University College of Medicine, Ansan Hospital
- Department of Psychiatry, Kangwon National University College of Medicine
- Department of Psychiatry, Kyungpook national University School of Medicine
- Department of Psychiatry, Eulji University, School of Medicine
- Department of Psychiatry, Chonnam National University Medical School
- Department of Psychiatry, College of Medicine, Won-Kwang University
- Department of Psychiatry, Gachon University of Medicine and Science
- Department of Psychiatry, Chonbuk national University Hospital
- Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine
- St. John of God Neuropsychiatric Hospital
- department of Neuropsychiatry. Dong-Eui University Medical Center
- Department of Neuropsychiatry, Soonchunhyang University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
drug
Arm Description
Outcomes
Primary Outcome Measures
Symptoms assessment by objective rating scales
PANSS total score, SANS, CGI
Symptoms assessment by objective rating scales
PANSS total score, SANS, CGI
Symptoms assessment by objective rating scales
PANSS total score, SANS, CGI
Symptoms assessment by objective rating scales
PANSS total score, SANS, CGI
Symptoms assessment by objective rating scales
PANSS total score, SANS, CGI, CAI(Cognitive Assessment Interview)
Secondary Outcome Measures
Assessment of adverse events by objective rating scales and self report scales profile
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS
Assessment of adverse events by objective rating scales and self report scales
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS
Assessment of adverse events by objective rating scales and self report scales
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS
Assessment of adverse events by objective rating scales and self report scales
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile
Full Information
NCT ID
NCT01157585
First Posted
June 30, 2010
Last Updated
July 30, 2015
Sponsor
Chonbuk National University Hospital
Collaborators
Janssen Korea, Ltd., Korea
1. Study Identification
Unique Protocol Identification Number
NCT01157585
Brief Title
Efficacy and Safety of Paliperidone ER in First Episode Psychosis
Official Title
Efficacy and Safety of Paliperidone ER in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
Collaborators
Janssen Korea, Ltd., Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Episode Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
drug
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
paliperidone ER
Intervention Description
8 week prospective study
Primary Outcome Measure Information:
Title
Symptoms assessment by objective rating scales
Description
PANSS total score, SANS, CGI
Time Frame
week 1
Title
Symptoms assessment by objective rating scales
Description
PANSS total score, SANS, CGI
Time Frame
week 2
Title
Symptoms assessment by objective rating scales
Description
PANSS total score, SANS, CGI
Time Frame
week 3
Title
Symptoms assessment by objective rating scales
Description
PANSS total score, SANS, CGI
Time Frame
week 4
Title
Symptoms assessment by objective rating scales
Description
PANSS total score, SANS, CGI, CAI(Cognitive Assessment Interview)
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Assessment of adverse events by objective rating scales and self report scales profile
Description
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS
Time Frame
week 1
Title
Assessment of adverse events by objective rating scales and self report scales
Description
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS
Time Frame
week 2
Title
Assessment of adverse events by objective rating scales and self report scales
Description
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS
Time Frame
week 4
Title
Assessment of adverse events by objective rating scales and self report scales
Description
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile
Time Frame
week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.
Exclusion Criteria:
Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence
Needing another nonantipsychotic psychotropic medication at enrollment
Having a serious or unstable medical illness.
Pregnant or lactating women or women without adequate contraception will be also excluded.
Facility Information:
Facility Name
Department of Psychiatry, Korea University College of Medicine, Ansan Hospital
City
Ansan
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Kangwon National University College of Medicine
City
Chunchon
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Kyungpook national University School of Medicine
City
Daegu
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Eulji University, School of Medicine
City
Daejeon
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Chonnam National University Medical School
City
Hwasun
Country
Korea, Republic of
Facility Name
Department of Psychiatry, College of Medicine, Won-Kwang University
City
Iksan
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Gachon University of Medicine and Science
City
Incheon
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Chonbuk national University Hospital
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine
City
Koyang
Country
Korea, Republic of
Facility Name
St. John of God Neuropsychiatric Hospital
City
Kwangju
Country
Korea, Republic of
Facility Name
department of Neuropsychiatry. Dong-Eui University Medical Center
City
Pusan
Country
Korea, Republic of
Facility Name
Department of Neuropsychiatry, Soonchunhyang University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Efficacy and Safety of Paliperidone ER in First Episode Psychosis
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