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Efficacy and Safety of Aripiprazole in First Episode Psychosis

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ClinicalTrials.gov Identifier: NCT01026584
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : February 13, 2012
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Young Chul Chung, Chonbuk National University Hospital

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

Condition or disease Intervention/treatment Phase
First Episode Psychosis Drug: Aripiprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
drug Drug: Aripiprazole
6 week prospective study



Primary Outcome Measures :
  1. Symptoms assessment by objective rating scales [ Time Frame: week 1 ]
    PANSS total score, SANS, CGI

  2. Symptoms assessment by objective rating scales [ Time Frame: week 2 ]
    PANSS total score, SANS, CGI

  3. Symptoms assessment by objective rating scales [ Time Frame: week 3 ]
    PANSS total score, SANS, CGI

  4. Symptoms assessment by objective rating scales [ Time Frame: week 4 ]
    PANSS total score, SANS, CGI

  5. Symptoms assessment by objective rating scales [ Time Frame: week 6 ]
    PANSS total score, SANS, CGI


Secondary Outcome Measures :
  1. Assessment of adverse events by objective rating scales and self report scales [ Time Frame: week 1 ]
    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS

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

  3. Assessment of adverse events by objective rating scales and self report scales [ Time Frame: week 4 ]
    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS

  4. Assessment of adverse events by objective rating scales and self report scales [ Time Frame: week 6 ]
    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

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
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs