Clinical trial NCT03839251: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: aripiprazole
long-acting injection
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2019-02-15
Enrollment: 82
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change from Baseline PSP(Personal and Social Performance scale) at 12weeks
timeFrame: 12weeks
measure: Change from Baseline PSP(Personal and Social Performance scale) at 24weeks
timeFrame: 24weeks
Secondary outcomes:
measure: Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)
timeFrame: baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks
measure: Efficacy Assessment by ERT(Emotional Recognition Test)
timeFrame: baseline, 24weeks
measure: Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)
timeFrame: baseline, 12weeks, 24weeks
measure: Efficacy Assessment by self rating scale
timeFrame: baseline, 12weeks, 24weeks
measure: Safety Assessment by Simpson-Angus Scale(SAS)
timeFrame: baseline, 12weeks, 24weeks
measure: Safety Assessment by Barnes Akathisia Rating Scale(BARS)
timeFrame: baseline, 12weeks, 24weeks
measure: Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)
timeFrame: baseline, 12weeks, 24weeks
measure: Safety Assessment by self report scale
timeFrame: baseline, 12weeks, 24weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of Psychiatry, Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Department of Psychiatry, Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Department of Psychiatry, Yeungnam University Medical Center
city: Gwangju
country: Korea, Republic of
facility: Department of Psychiatry, Chonnam National University Medical School
city: Jeonju
country: Korea, Republic of
facility: Department of Psychiatry, Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Young-chul Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: