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

Sponsor
Chonbuk National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03839251
Collaborator
Otsuka Pharmaceutical Co., Ltd. (Industry)
82
Enrollment
5
Locations
1
Arm
28
Actual Duration (Months)
16.4
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: abilify maintena
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Jan 22, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline PSP(Personal and Social Performance scale) at 12weeks [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.

    2. Change from Baseline PSP(Personal and Social Performance scale) at 24weeks [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

    1. Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia) [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.

    2. Efficacy Assessment by ERT(Emotional Recognition Test) [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.

    3. Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale) [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.

    4. Efficacy Assessment by self rating scale [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.

    5. Safety Assessment by Simpson-Angus Scale(SAS) [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.

    6. Safety Assessment by Barnes Akathisia Rating Scale(BARS) [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.

    7. Safety Assessment by Abnormal Involuntary Movement Scale(AIMS) [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.

    8. Safety Assessment by self report scale [baseline, 12weeks, 24weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Psychiatry, Inje University Haeundae Paik Hospital Busan Korea, Republic of
    2 Department of Psychiatry, Kyungpook National University Hospital Daegu Korea, Republic of
    3 Department of Psychiatry, Yeungnam University Medical Center Daegu Korea, Republic of
    4 Department of Psychiatry, Chonnam National University Medical School Gwangju Korea, Republic of
    5 Department of Psychiatry, Chonbuk National University Hospital Jeonju Korea, Republic of

    Sponsors and Collaborators

    • Chonbuk National University Hospital
    • Otsuka Pharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: Young-chul Chung, MD, Chonbuk National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Young Chul Chung, Professor of Psychiatry, Chonbuk National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03839251
    Other Study ID Numbers:
    • CUH 2018-02-011-005
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Jan 27, 2021
    Last Verified:
    Jan 1, 2021
    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
    Keywords provided by Young Chul Chung, Professor of Psychiatry, Chonbuk National University Hospital
    aripiprazole
    long-acting injection
    Additional relevant MeSH terms:
    Schizophrenia
    Aripiprazole

    Study Results

    No Results Posted as of Jan 27, 2021