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

Chonbuk National University Hospital82 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

abilify maintenaDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (5)

Department of Psychiatry, Inje University Haeundae Paik Hospital

Busan, South Korea

Department of Psychiatry, Kyungpook National University Hospital

Daegu, South Korea

Department of Psychiatry, Yeungnam University Medical Center

Daegu, South Korea

Department of Psychiatry, Chonnam National University Medical School

Gwangju, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 12weeks

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.

Time frame: 24weeks

Secondary Outcomes

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.

Time frame: baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks

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.

Time frame: baseline, 24weeks

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.

Data from ClinicalTrials.gov

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