Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients

NCT ID: NCT03839251

Last Updated: 2021-01-27

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

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-09-30

Brief Summary

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The aim of the study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients

Detailed Description

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The aim of this study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients

Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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abilify maintena

aripiprazole 400mg or 300mg, IM, Once a month

Group Type OTHER

abilify maintena

Intervention Type DRUG

aripiprazole 400mg or 300mg, IM, Once a month

Interventions

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abilify maintena

aripiprazole 400mg or 300mg, IM, Once a month

Intervention Type DRUG

Other Intervention Names

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aripiprazole

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with schizophrenia according to DSM-5 diagnostic standards
* men and women aged 19 and under 60
* a person who is being given an atypical antipsychotic.
* Patients should be able to reasonably cooperate with the questionnaire to be used for the study
* a person who fully understands the purpose of the study and signs the consent
* stable outpatient before screening without changing the volume of antipsychotics for at least two weeks

Exclusion Criteria

* a person who has a serious and unstable physical condition either now or in the past
* A fertile woman who is currently pregnant or breastfeeding, or who is either unwilling or unable to use acceptable contraception until the clinical trial is complete.
* a person suffering from severe drug allergies or complex and severe drug reactions
* Patients who have taken clozapine in the last 60 days
* subjects showing significant risk of suicide or significant risk of violent behavior based on past history or investigator's judgment
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

Principal Investigators

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Young-chul Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Department of Psychiatry, Inje University Haeundae Paik Hospital

Busan, , South Korea

Site Status

Department of Psychiatry, Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Department of Psychiatry, Yeungnam University Medical Center

Daegu, , South Korea

Site Status

Department of Psychiatry, Chonnam National University Medical School

Gwangju, , South Korea

Site Status

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CUH 2018-02-011-005

Identifier Type: -

Identifier Source: org_study_id

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