Clinical trial NCT01157585: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: First Episode Psychosis
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: Janssen Korea, Ltd., Korea
First posted: 2010-07-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Symptoms assessment by objective rating scales
timeFrame: week 1
measure: Symptoms assessment by objective rating scales
timeFrame: week 2
measure: Symptoms assessment by objective rating scales
timeFrame: week 3
measure: Symptoms assessment by objective rating scales
timeFrame: week 4
measure: Symptoms assessment by objective rating scales
timeFrame: week 8
Secondary outcomes:
measure: Assessment of adverse events by objective rating scales and self report scales profile
timeFrame: week 1
measure: Assessment of adverse events by objective rating scales and self report scales
timeFrame: week 2
measure: Assessment of adverse events by objective rating scales and self report scales
timeFrame: week 4
measure: Assessment of adverse events by objective rating scales and self report scales
timeFrame: week 8
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Department of Psychiatry, Korea University College of Medicine, Ansan Hospital
city: Chunchon
country: Korea, Republic of
facility: Department of Psychiatry, Kangwon National University College of Medicine
city: Daegu
country: Korea, Republic of
facility: Department of Psychiatry, Kyungpook national University School of Medicine
city: Daejeon
country: Korea, Republic of
facility: Department of Psychiatry, Eulji University, School of Medicine
city: Hwasun
country: Korea, Republic of
facility: Department of Psychiatry, Chonnam National University Medical School
city: Iksan
country: Korea, Republic of
facility: Department of Psychiatry, College of Medicine, Won-Kwang University
city: Incheon
country: Korea, Republic of
facility: Department of Psychiatry, Gachon University of Medicine and Science
city: Jeonju
country: Korea, Republic of
facility: Department of Psychiatry, Chonbuk national University Hospital
city: Koyang
country: Korea, Republic of
facility: Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine
city: Kwangju
country: Korea, Republic of
facility: St. John of God Neuropsychiatric Hospital
city: Pusan
country: Korea, Republic of
facility: department of Neuropsychiatry. Dong-Eui University Medical Center
city: Seoul
country: Korea, Republic of
facility: Department of Neuropsychiatry, Soonchunhyang University Hospital
Study officials:
References: