Efficacy and Safety of Paliperidone ER in First Episode Psychosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Chonbuk National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Young Chul Chung, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01157585
First received: June 30, 2010
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
First Episode Psychosis
Drug: paliperidone ER
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Paliperidone ER in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study

Resource links provided by NLM:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Symptoms assessment by objective rating scales [ Time Frame: week 1 ] [ Designated as safety issue: No ]
    PANSS total score, SANS, CGI

  • Symptoms assessment by objective rating scales [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    PANSS total score, SANS, CGI

  • Symptoms assessment by objective rating scales [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    PANSS total score, SANS, CGI

  • Symptoms assessment by objective rating scales [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    PANSS total score, SANS, CGI

  • Symptoms assessment by objective rating scales [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 1 ] [ Designated as safety issue: Yes ]
    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS

  • Assessment of adverse events by objective rating scales and self report scales [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS

  • Assessment of adverse events by objective rating scales and self report scales [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS

  • Assessment of adverse events by objective rating scales and self report scales [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile


Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
drug Drug: paliperidone ER
8 week prospective study

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157585

Contacts
Contact: Young Chul Chung, MD 82 63 250 2185 chungyc@jbnu.ac.kr

Locations
Korea, Republic of
Department of Psychiatry, Korea University College of Medicine, Ansan Hospital Recruiting
Ansan, Korea, Republic of
Contact: Chang soo Han, MD    +82 10 9129 7512    hancs@korea.ac.kr   
Department of Psychiatry, Kangwon National University College of Medicine Recruiting
Chunchon, Korea, Republic of
Contact: Byul Nim Kim    82 10 4747 8398    comic8201@nate.com   
Sub-Investigator: Jong Ik Park, MD         
Department of Psychiatry, Kyungpook national University School of Medicine Recruiting
Daegu, Korea, Republic of
Contact: Kyeong Ae Kang    82 10 7655 2919      
Sub-Investigator: Seung Jae Lee, MD         
Department of Psychiatry, Eulji University, School of Medicine Recruiting
Daejeon, Korea, Republic of
Contact: Ki Poong Lee    82 10 4366 8130      
Sub-Investigator: Bum Seok Jeong, MD         
Department of Psychiatry, Chonnam National University Medical School Recruiting
Hwasun, Korea, Republic of
Contact: Ahn na Cho    82 19 661 9694      
Sub-Investigator: Sung Wan Kim, MD         
Department of Psychiatry, College of Medicine, Won-Kwang University Recruiting
Iksan, Korea, Republic of
Contact: Ji Hoon Park    82 10 9644 5106      
Sub-Investigator: Seung Ho Rho, MD         
Department of Psychiatry, Gachon University of Medicine and Science Recruiting
Incheon, Korea, Republic of
Contact: Jin Young Lee    82 10 4053 4289      
Sub-Investigator: Jong Hoon Kim, MD         
Department of Psychiatry, Chonbuk national University Hospital Recruiting
Jeonju, Korea, Republic of, 561-712
Contact: Jeong Hyun Kim    82 63 250 1688      
Principal Investigator: Young Chul Chung, MD         
Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine Recruiting
Koyang, Korea, Republic of
Contact: Eun Joo Kim    82 10 3011 2217      
Sub-Investigator: Min Sung Koo, MD         
St. John of God Neuropsychiatric Hospital Recruiting
Kwangju, Korea, Republic of
Contact: Bock Ja Park    82 10 4354 7708      
Sub-Investigator: Yo Han Lee, MD         
department of Neuropsychiatry. Dong-Eui University Medical Center Recruiting
Pusan, Korea, Republic of
Contact: Hye-jung Ji    82 51 850 8923    PSYPIA@hanmail.net   
Sub-Investigator: Dong Hwan Cho, MD         
Department of Neuropsychiatry, Soonchunhyang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seon Nyeo Park    82 10 8956 5773      
Sub-Investigator: Sang Woo Han, MD         
Sponsors and Collaborators
Chonbuk National University Hospital
Janssen Korea, Ltd., Korea
  More Information

No publications provided

Responsible Party: Young Chul Chung, Professor of Psychiatry, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01157585     History of Changes
Other Study ID Numbers: CBIRB0912-141
Study First Received: June 30, 2010
Last Updated: February 9, 2012
Health Authority: Republic of Korea: Chonbuk National University Hospital Institutional Review Board

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014