Efficacy and Safety of Paliperidone ER in First Episode Psychosis

First Episode Psychosis Clinical Trial

Official title:

Efficacy and Safety of Paliperidone ER in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157585
• Other study ID #: CBIRB0912-141
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2010
• Last updated: July 30, 2015
• Start date: February 2010
• Est. completion date: February 2013

Study information

• Verified date: July 2015
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Chonbuk National University Hospital Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• First Episode Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• paliperidone ER
8 week prospective study

Locations

Country	Name	City	State
Korea, Republic of	Department of Psychiatry, Korea University College of Medicine, Ansan Hospital	Ansan
Korea, Republic of	Department of Psychiatry, Kangwon National University College of Medicine	Chunchon
Korea, Republic of	Department of Psychiatry, Kyungpook national University School of Medicine	Daegu
Korea, Republic of	Department of Psychiatry, Eulji University, School of Medicine	Daejeon
Korea, Republic of	Department of Psychiatry, Chonnam National University Medical School	Hwasun
Korea, Republic of	Department of Psychiatry, College of Medicine, Won-Kwang University	Iksan
Korea, Republic of	Department of Psychiatry, Gachon University of Medicine and Science	Incheon
Korea, Republic of	Department of Psychiatry, Chonbuk national University Hospital	Jeonju
Korea, Republic of	Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine	Koyang
Korea, Republic of	St. John of God Neuropsychiatric Hospital	Kwangju
Korea, Republic of	department of Neuropsychiatry. Dong-Eui University Medical Center	Pusan
Korea, Republic of	Department of Neuropsychiatry, Soonchunhyang University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chonbuk National University Hospital	Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms assessment by objective rating scales	PANSS total score, SANS, CGI	week 1	No
Primary	Symptoms assessment by objective rating scales	PANSS total score, SANS, CGI	week 2	No
Primary	Symptoms assessment by objective rating scales	PANSS total score, SANS, CGI	week 3	No
Primary	Symptoms assessment by objective rating scales	PANSS total score, SANS, CGI	week 4	No
Primary	Symptoms assessment by objective rating scales	PANSS total score, SANS, CGI, CAI(Cognitive Assessment Interview)	week 8	No
Secondary	Assessment of adverse events by objective rating scales and self report scales profile	NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS	week 1	Yes
Secondary	Assessment of adverse events by objective rating scales and self report scales	NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS	week 2	Yes
Secondary	Assessment of adverse events by objective rating scales and self report scales	NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS	week 4	Yes
Secondary	Assessment of adverse events by objective rating scales and self report scales	NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile	week 8	Yes