Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
Overview
- Phase
- Phase 4
- Intervention
- abilify maintena
- Conditions
- Schizophrenia
- Sponsor
- Chonbuk National University Hospital
- Enrollment
- 82
- Locations
- 5
- Primary Endpoint
- Change from Baseline PSP(Personal and Social Performance scale) at 12weeks
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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
Investigators
Young Chul Chung
Professor of Psychiatry
Chonbuk National University Hospital
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
Arms & Interventions
abilify maintena
aripiprazole 400mg or 300mg, IM, Once a month
Intervention: abilify maintena
Outcomes
Primary Outcomes
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 Outcomes
- Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)(baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks)
- Efficacy Assessment by ERT(Emotional Recognition Test)(baseline, 24weeks)
- Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)(baseline, 12weeks, 24weeks)
- Efficacy Assessment by self rating scale(baseline, 12weeks, 24weeks)
- Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)(baseline, 12weeks, 24weeks)
- Safety Assessment by Simpson-Angus Scale(SAS)(baseline, 12weeks, 24weeks)
- Safety Assessment by Barnes Akathisia Rating Scale(BARS)(baseline, 12weeks, 24weeks)
- Safety Assessment by self report scale(baseline, 12weeks, 24weeks)