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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 22, 2020

Detailed Description

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

Interventions

  • Drug: abilify maintena
    • aripiprazole 400mg or 300mg, IM, Once a month

Arms, Groups and Cohorts

  • Other: abilify maintena
    • aripiprazole 400mg or 300mg, IM, Once a month

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chonbuk National University Hospital
  • Collaborator
    • Otsuka Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Young Chul Chung, Professor of Psychiatry – Chonbuk National University Hospital
  • Overall Official(s)
    • Young-chul Chung, MD, Principal Investigator, Chonbuk National University Hospital

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