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

January 25, 2021 updated by: Young Chul Chung, Chonbuk National University Hospital
The aim of the study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Department of Psychiatry, Inje University Haeundae Paik Hospital
      • Daegu, Korea, Republic of
        • Department of Psychiatry, Kyungpook National University Hospital
      • Daegu, Korea, Republic of
        • Department of Psychiatry, Yeungnam University Medical Center
      • Gwangju, Korea, Republic of
        • Department of Psychiatry, Chonnam National University Medical School
      • Jeonju, Korea, Republic of
        • Department of Psychiatry, Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: abilify maintena
aripiprazole 400mg or 300mg, IM, Once a month
Drug: abilify maintena
aripiprazole 400mg or 300mg, IM, Once a month
Other Names:
  • aripiprazole

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline PSP(Personal and Social Performance scale) at 12weeks
Time Frame: 12weeks
PSP(Personal and Social Performance scale) was measured in baseline and 12week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.
12weeks
Change from Baseline PSP(Personal and Social Performance scale) at 24weeks
Time Frame: 24weeks
PSP(Personal and Social Performance scale) was measured in baseline and 24week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.
24weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)
Time Frame: baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks

Clinical global impression-schizophrenia(CGI-S)

There are Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity in the Clinical global impression-schizophrenia(CGI-S). minimum of each items(Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity) is 1, Maximum is 7. The higher number is worse outcome.
baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks
Efficacy Assessment by ERT(Emotional Recognition Test)
Time Frame: baseline, 24weeks

Emotional Recognition Test(ERT)

minimum of ERT(Emotional Recognition Test) total score is 0, Maximum is 54. The lower number is worse outcome.
baseline, 24weeks
Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)
Time Frame: baseline, 12weeks, 24weeks

Positive and Negative Syndrome Scale(PANSS)

There are Positive Scale, Negative Scale and General Psychopathology Scale in the PANSS(Positive and Negative Syndrome Scale). minimum of each items(Positive Scale, Negative Scale and General Psychopathology Scale) is 1, Maximum is 7. The higher number is worse outcome.
baseline, 12weeks, 24weeks
Efficacy Assessment by self rating scale
Time Frame: baseline, 12weeks, 24weeks

Subjective Wellbeing under Neuroleptics(SWN-K)

SWN-K(Subjective Wellbeing under Neuroleptics) consists of 20 questions. The minimum score for each question is zero and the maximum score is five. The reverse scoring questions include 1,4,6,9,10,11,12,14,16,17. The total score of the whole item is obtained, and the lower the score, the worse the subjective well-being.
baseline, 12weeks, 24weeks
Safety Assessment by Simpson-Angus Scale(SAS)
Time Frame: baseline, 12weeks, 24weeks

Simpson-Angus Scale(SAS)

minimum of each items(Gait, Arm Dropping, Shoulder Shaking, Elbow Rigidity, Fixation of Position or Wrist Rigidity, Leg Pendulousness, Head Dropping, Glabella Tap, Tremor, Salivation) in the SAS(Simpson-Angus Scale) is 0, Maximum is 4. minimum of total scores in the SAS(Simpson-Angus Scale) is 0, Maximum is 40. The higher number is worse outcome.
baseline, 12weeks, 24weeks
Safety Assessment by Barnes Akathisia Rating Scale(BARS)
Time Frame: baseline, 12weeks, 24weeks

Barnes Akathisia Rating Scale(BARS)

minimum of each items(Objective, Subjective, Distress related to restlessness) in the BAS(Barnes Akathisia Rating Scale) is 0, Maximum is 3. Minimum of Global clinical assessment of akathisia in the BARS is 0, Maximum is 5. The higher number is worse outcome.
baseline, 12weeks, 24weeks
Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)
Time Frame: baseline, 12weeks, 24weeks

Abnormal Involuntary Movement Scale(AIMS)

minimum of each items in the AIMS(Abnormal Involuntary Movement Scale) is 0, Maximum is 4. The higher number is worse outcome.
baseline, 12weeks, 24weeks
Safety Assessment by self report scale
Time Frame: baseline, 12weeks, 24weeks

Visual Analogue Scale(VAS)

minimum of VAS(Visual Analogue Scale) is 0, Maximum is 10. The higher number is worse outcome.
baseline, 12weeks, 24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chonbuk National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CUH 2018-02-011-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings