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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-101147 | Other Identifier | JAPIC |
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The objective of this study is to investigate the safety and efficacy of aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over a period of 52 weeks in subjects who complete a short-term treatment study of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Experimental | Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score | The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition. | Basline and Week52 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score | The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoji Imaoka, Mr | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score | The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition. | Posted | Mean | Standard Deviation | units on a scale | Basline and Week52 |
|
From the start date of screening examination to date of the final examination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole | Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional overdose | Injury, poisoning and procedural complications | MeDRA/J Ver. 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd | +81-3-6361-7366 |
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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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| Basline and Week52 |
| Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS) | The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition. | Baseline and Week52 |
| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Kansai Region | Japan |
| Kanto Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
| Protocol Violation |
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| Withdrawal by Subject |
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| Use of the prohibition medicine |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score | The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition. | Posted | Mean | Standard Deviation | units on a scale | Basline and Week52 |
|
|
|
| Secondary | Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS) | The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week52 |
|
|
|
| 7 |
| 68 |
| 61 |
| 68 |
| Decreased appetite | Metabolism and nutrition disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Delusion | Psychiatric disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Otitis externa | Infections and infestations | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Weight decreased | Investigations | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Weight increased | Investigations | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MeDRA/J Ver. 17.0 | Systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |