Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients
- Registration Number
- NCT03839251
- Lead Sponsor
- Chonbuk National University Hospital
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description abilify maintena abilify maintena aripiprazole 400mg or 300mg, IM, Once a month
- Primary Outcome Measures
Name Time Method 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.
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
Name Time Method 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.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.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.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.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.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.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.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.
Trial Locations
- Locations (5)
Department of Psychiatry, Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Department of Psychiatry, Chonnam National University Medical School
🇰🇷Gwangju, Korea, Republic of
Department of Psychiatry, Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Department of Psychiatry, Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Department of Psychiatry, Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of