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Efficacy and Safety of Aripiprazole in First Episode Psychosis

This study has been completed.
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by (Responsible Party):
Young Chul Chung, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01026584
First received: December 3, 2009
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
First Episode Psychosis
 Drug: Aripiprazole
 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 Aripiprazole in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study

Resource links provided by NLM:

U.S. FDA Resources

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 6 ] [ Designated as safety issue: No ]
    PANSS total score, SANS, CGI


Secondary Outcome Measures:
  • Assessment of adverse events by objective rating scales and self report scales [ 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 6 ] [ Designated as safety issue: Yes ]
    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile


Enrollment: 55
Study Start Date: October 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
drug Drug: Aripiprazole
6 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026584

Locations
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, Kongju National Hospital
Gongju, Korea, Republic of
Department of Psychiatry, Inje University College of Medicine, Ilsan Paik Hospital
Goyang, 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, 561-712
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, Korea, Republic of
Sponsors and Collaborators
Chonbuk National University Hospital
Korea Otsuka Pharmaceutical Co.,Ltd.
  More Information

No publications provided

Responsible Party: Young Chul Chung, Professor of Psychiatry, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01026584     History of Changes
Other Study ID Numbers: CBIRB0909-97
Study First Received: December 3, 2009
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
Aripiprazole
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 May 19, 2013