Status:
COMPLETED
Efficacy and Safety of Paliperidone ER in First Episode Psychosis
Lead Sponsor:
Chonbuk National University Hospital
Collaborating Sponsors:
Janssen Korea, Ltd., Korea
Conditions:
First Episode Psychosis
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief Summary
The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01157585
Start Date
February 1 2010
End Date
February 1 2013
Last Update
July 31 2015
Active Locations (12)
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1
Department of Psychiatry, Korea University College of Medicine, Ansan Hospital
Ansan, South Korea
2
Department of Psychiatry, Kangwon National University College of Medicine
Chunchon, South Korea
3
Department of Psychiatry, Kyungpook national University School of Medicine
Daegu, South Korea
4
Department of Psychiatry, Eulji University, School of Medicine
Daejeon, South Korea