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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abilify maintena | Other | aripiprazole 400mg or 300mg, IM, Once a month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abilify maintena | Drug | aripiprazole 400mg or 300mg, IM, Once a month |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-chul Chung, MD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Inje University Haeundae Paik Hospital | Busan | South Korea | ||||
| Department of Psychiatry, Kyungpook National University Hospital |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| 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. | 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. | baseline, 12weeks, 24weeks |
| Efficacy Assessment by self rating scale | 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. | baseline, 12weeks, 24weeks |
| Safety Assessment by Simpson-Angus Scale(SAS) | 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. | baseline, 12weeks, 24weeks |
| Safety Assessment by Barnes Akathisia Rating Scale(BARS) | 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. | baseline, 12weeks, 24weeks |
| Safety Assessment by Abnormal Involuntary Movement Scale(AIMS) | 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. | baseline, 12weeks, 24weeks |
| Safety Assessment by self report scale | Visual Analogue Scale(VAS) minimum of VAS(Visual Analogue Scale) is 0, Maximum is 10. The higher number is worse outcome. | baseline, 12weeks, 24weeks |
| Daegu |
| South Korea |
| Department of Psychiatry, Yeungnam University Medical Center | Daegu | South Korea |
| Department of Psychiatry, Chonnam National University Medical School | Gwangju | South Korea |
| Department of Psychiatry, Chonbuk National University Hospital | Jeonju | South Korea |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |