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The purpose of this study is to prove safety and efficacy of aripiprazole.
This study was designed to prove safety and efficacy of aripiprazole in the treatment of acutely relapsed patients with diagnoses of schizophrenia or schizoaffective disorder in Korea and to confirm the maintenance of efficacy and safety during maintenance period and the changes in emotional factors and social functions.
After administering 15 mg/day of aripiprazole for two weeks, the test may change the dose within the range of 10 mg and 30 mg per day by clinical judgment. (Medication duration: 8 weeks (acute phase) + 18 weeks (maintenance phase)] + 26 weeks (extension phase), *total 52 weeks)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| PANSS-total score (at screening, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52) |
| Measure | Description | Time Frame |
|---|---|---|
| [Efficacy] PANSS-positive, PANSS-negative, CGI-severity score (at screening, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52) | ||
| [Safety] AEs (at baseline, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun-Su Kwon, Prof. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| 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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| SAS, AIMS, Barnes (at baseline, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52) |
| vital signs (at screening, baseline, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52) |
| body weight (at screening, baseline, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52) |
| electrocardiogram (ECG) (at screening & week 8) |
| serum prolactin concentration (at screening & week 8) |
| routine laboratory test (at screening & week 8) |
| urinalysis (at screening & week 8) |
| Pharmacokinetic is evaluated by concentration of aripiprazole in blood (at Week 3, 4, 6, 8). |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |