Efficacy and Safety of Aripiprazole in First Episode Psychosis

NCT ID: NCT01026584

Last Updated: 2012-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-02-29

Brief Summary

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

Detailed Description

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Conditions

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First Episode Psychosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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drug

Group Type OTHER

Aripiprazole

Intervention Type DRUG

6 week prospective study

Interventions

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Aripiprazole

6 week prospective study

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Chul Chung

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychiatry, Kangwon National University College of Medicine

Chunchon, , South Korea

Site Status

Department of Psychiatry, Kyungpook national University School of Medicine

Daegu, , South Korea

Site Status

Department of Psychiatry, Eulji University, School of Medicine

Daejeon, , South Korea

Site Status

Department of Psychiatry, Kongju National Hospital

Gongju, , South Korea

Site Status

Department of Psychiatry, Inje University College of Medicine, Ilsan Paik Hospital

Goyang, , South Korea

Site Status

Department of Psychiatry, Chonnam National University Medical School

Hwasun, , South Korea

Site Status

Department of Psychiatry, College of Medicine, Won-Kwang University

Iksan, , South Korea

Site Status

Department of Psychiatry, Gachon University of Medicine and Science

Incheon, , South Korea

Site Status

Department of Psychiatry, Chonbuk national University Hospital

Jeonju, , South Korea

Site Status

Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine

Koyang, , South Korea

Site Status

St. John of God Neuropsychiatric Hospital

Kwangju, , South Korea

Site Status

department of Neuropsychiatry. Dong-Eui University Medical Center

Pusan, , South Korea

Site Status

Department of Neuropsychiatry, Soonchunhyang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CBIRB0909-97

Identifier Type: -

Identifier Source: org_study_id

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