search
Back to results

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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
abilify maintena
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring aripiprazole, long-acting injection

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, Inje University Haeundae Paik Hospital
  • Department of Psychiatry, Kyungpook National University Hospital
  • Department of Psychiatry, Yeungnam University Medical Center
  • Department of Psychiatry, Chonnam National University Medical School
  • Department of Psychiatry, Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

abilify maintena

Arm Description

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

Outcomes

Primary Outcome Measures

Change from Baseline PSP(Personal and Social Performance scale) at 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.
Change from Baseline PSP(Personal and Social Performance scale) at 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.

Secondary Outcome Measures

Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)
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.
Efficacy Assessment by ERT(Emotional Recognition Test)
Emotional Recognition Test(ERT) minimum of ERT(Emotional Recognition Test) total score is 0, Maximum is 54. The lower number is worse outcome.
Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)
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.
Efficacy Assessment by self rating scale
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.
Safety Assessment by Simpson-Angus Scale(SAS)
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.
Safety Assessment by Barnes Akathisia Rating Scale(BARS)
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.
Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)
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.
Safety Assessment by self report scale
Visual Analogue Scale(VAS) minimum of VAS(Visual Analogue Scale) is 0, Maximum is 10. The higher number is worse outcome.

Full Information

First Posted
January 29, 2019
Last Updated
January 25, 2021
Sponsor
Chonbuk National University Hospital
Collaborators
Otsuka Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03839251
Brief Title
Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
Official Title
Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
aripiprazole, long-acting injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
abilify maintena
Arm Type
Other
Arm Description
aripiprazole 400mg or 300mg, IM, Once a month
Intervention Type
Drug
Intervention Name(s)
abilify maintena
Other Intervention Name(s)
aripiprazole
Intervention Description
aripiprazole 400mg or 300mg, IM, Once a month
Primary Outcome Measure Information:
Title
Change from Baseline PSP(Personal and Social Performance scale) at 12weeks
Description
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.
Time Frame
12weeks
Title
Change from Baseline PSP(Personal and Social Performance scale) at 24weeks
Description
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.
Time Frame
24weeks
Secondary Outcome Measure Information:
Title
Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)
Description
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.
Time Frame
baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks
Title
Efficacy Assessment by ERT(Emotional Recognition Test)
Description
Emotional Recognition Test(ERT) minimum of ERT(Emotional Recognition Test) total score is 0, Maximum is 54. The lower number is worse outcome.
Time Frame
baseline, 24weeks
Title
Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)
Description
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.
Time Frame
baseline, 12weeks, 24weeks
Title
Efficacy Assessment by self rating scale
Description
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.
Time Frame
baseline, 12weeks, 24weeks
Title
Safety Assessment by Simpson-Angus Scale(SAS)
Description
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.
Time Frame
baseline, 12weeks, 24weeks
Title
Safety Assessment by Barnes Akathisia Rating Scale(BARS)
Description
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.
Time Frame
baseline, 12weeks, 24weeks
Title
Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)
Description
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.
Time Frame
baseline, 12weeks, 24weeks
Title
Safety Assessment by self report scale
Description
Visual Analogue Scale(VAS) minimum of VAS(Visual Analogue Scale) is 0, Maximum is 10. The higher number is worse outcome.
Time Frame
baseline, 12weeks, 24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-chul Chung, MD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Inje University Haeundae Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Chonnam National University Medical School
City
Gwangju
Country
Korea, Republic of
Facility Name
Department of Psychiatry, Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs