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The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole 10 mg/day Group | Active Comparator | Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25 |
|
| Aripiprazole 30 mg/day Group | Active Comparator | Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25 |
|
| Placebo Group | Placebo Comparator | Participants were given a single pill administered once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole tablet, 10 mg | Drug | Aripiprazole tablet 10 mg po qd x 42 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score | Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome. | Baseline and Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score | Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward. Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score | Change from baseline to last observed post-baseline value in PQLES total score, using the last observation carried forward. Scale consists of 14 items pertaining to daily life activities and satisfaction, and an overall assessment item. Each item will be rated on a five-point scale (1=very poor, 2=poor, 3=fair, 4=good, 5=very good) with a minimum score of 14 (better outcome) and a maximum score of 70 (worse outcome). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaretta Nyilas, M.D. | Otsuka Pharmaceutical Development & Commercialization, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Birmingham | Alabama | United States | |||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23800482 | Derived | Correll CU, Zhao J, Carson W, Marcus R, McQuade R, Forbes RA, Mankoski R. Early antipsychotic response to aripiprazole in adolescents with schizophrenia: predictive value for clinical outcomes. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):689-698.e3. doi: 10.1016/j.jaac.2013.04.018. Epub 2013 Jun 5. | |
| 20166794 | Derived |
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Participants were screened over a 4-week period.
Participants were recruited from 101 centers in the United States, Europe, South America, the Caribbean, and South Africa between August 2004 and August 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole 10 mg/Day Group | Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25 |
| FG001 | Aripiprazole 30 mg/Day Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Aripiprazole tablet, 30 mg | Drug | Aripiprazole tablet 30 mg po qd x 42 days |
|
|
| Placebo tablet | Drug | Placebo tablet po qd x 42 days |
|
| Baseline and Day 42 |
| Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score | Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward. Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome. | Baseline and Day 42 |
| Change in Clinical Global Impression (CGI) Severity Score | Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe). | Baseline and Day 42 |
| Clinical Global Impression (CGI) Improvement Score | Last observed post-baseline value in CGI improvement score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe). | Baseline and Day 42 |
| Change in Children's Global Assessment Scale (CGAS) Score | Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward. Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome). | Baseline and Day 42 |
| Baseline and Day 42 |
| Patients Achieving Remission | The number of subjects achieving remission. Remission was defined as a score of mild or less (≤ 3) for items P1, P2, P3, N1, N4, N6, G5, and G9 in the PANSS score. | Baseline and Day 42 |
| Little Rock |
| Arkansas |
| United States |
| Local Institution | Costa Mesa | California | United States |
| Local Institution | Los Angeles | California | United States |
| Local Institution | National City | California | United States |
| Local Institution | Orange | California | United States |
| Local Institution | Pasadena | California | United States |
| Local Institution | Sacramento | California | United States |
| Local Institution | San Diego | California | United States |
| Local Institution | Temecula | California | United States |
| Local Institution | Washington D.C. | District of Columbia | United States |
| Local Institution | Altamonte Springs | Florida | United States |
| Local Institution | Fort Lauderdale | Florida | United States |
| Local Institution | Gainesville | Florida | United States |
| Local Institution | Hialeah | Florida | United States |
| Local Institution | Jacksonville | Florida | United States |
| Local Institution | Miami | Florida | United States |
| Local Institution | North Miami | Florida | United States |
| Local Institution | Orange City | Florida | United States |
| Local Institution | Tampa | Florida | United States |
| Local Institution | Newnan | Georgia | United States |
| Local Institution | Smyrna | Georgia | United States |
| Local Institution | Honolulu | Hawaii | United States |
| Local Institution | Chicago | Illinois | United States |
| Local Institution | Kansas City | Kansas | United States |
| Local Institution | Lexington | Kentucky | United States |
| Local Institution | Lake Charles | Louisiana | United States |
| Local Institution | New Orleans | Louisiana | United States |
| Local Institution | Medford | Massachusetts | United States |
| Local Institution | Clinton Township | Michigan | United States |
| Local Institution | Flowood | Mississippi | United States |
| Local Institution | Kansas City | Missouri | United States |
| Local Institution | Las Vegas | Nevada | United States |
| Local Institution | Elmsford | New York | United States |
| Local Institution | New York | New York | United States |
| Local Institution | Olean | New York | United States |
| Local Institution | Rochester | New York | United States |
| Local Institution | Chapel Hill | North Carolina | United States |
| Local Institution | Cleveland | Ohio | United States |
| Local Institution | Lyndhurst | Ohio | United States |
| Local Institution | Oklahoma City | Oklahoma | United States |
| Local Institution | Bala-Cynwyd | Pennsylvania | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Memphis | Tennessee | United States |
| Local Institution | Bellaire | Texas | United States |
| Local Institution | DeSoto | Texas | United States |
| Local Institution | Houston | Texas | United States |
| Local Institution | San Antonio | Texas | United States |
| Local Institution | Salt Lake City | Utah | United States |
| Local Institution | Richmond | Virginia | United States |
| Local Institution | Kirkland | Washington | United States |
| Local Institution | Spokane | Washington | United States |
| Local Institution | Wauwatosa | Wisconsin | United States |
| Local Institution | Rio Piedras | Puerto Rico |
| Local Institution | San Juan | Puerto Rico |
| Robb AS, Carson WH, Nyilas M, Ali M, Forbes RA, Iwamoto T, Assuncao-Talbott S, Whitehead R, Pikalov A. Changes in positive and negative syndrome scale-derived hostility factor in adolescents with schizophrenia treated with aripiprazole: post hoc analysis of randomized clinical trial data. J Child Adolesc Psychopharmacol. 2010 Feb;20(1):33-8. doi: 10.1089/cap.2008.0163. |
| 18765484 | Derived | Findling RL, Robb A, Nyilas M, Forbes RA, Jin N, Ivanova S, Marcus R, McQuade RD, Iwamoto T, Carson WH. A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia. Am J Psychiatry. 2008 Nov;165(11):1432-41. doi: 10.1176/appi.ajp.2008.07061035. Epub 2008 Sep 2. |
Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25 |
| FG002 | Placebo Group | Participants were given a single pill administered once daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole 10 mg/Day Group | Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25 |
| BG001 | Aripiprazole 30 mg/Day Group | Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25 |
| BG002 | Placebo Group | Participants were given a single pill administered once daily |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Change in Positive and Negative Syndrome Scale (PANSS) Total Score | Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome. | Posted | Mean | Standard Error | points | Baseline and Day 42 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score | Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward. Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome. | Posted | Mean | Standard Error | points | Baseline and Day 42 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score | Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward. Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome. | Posted | Mean | Standard Error | points | Baseline and Day 42 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Clinical Global Impression (CGI) Severity Score | Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe). | Posted | Mean | Standard Error | points | Baseline and Day 42 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression (CGI) Improvement Score | Last observed post-baseline value in CGI improvement score, using the last observation carried forward. Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe). | Posted | Mean | Standard Error | points | Baseline and Day 42 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Children's Global Assessment Scale (CGAS) Score | Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward. Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome). | Posted | Mean | Standard Error | points | Baseline and Day 42 |
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| Other Pre-specified | Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score | Change from baseline to last observed post-baseline value in PQLES total score, using the last observation carried forward. Scale consists of 14 items pertaining to daily life activities and satisfaction, and an overall assessment item. Each item will be rated on a five-point scale (1=very poor, 2=poor, 3=fair, 4=good, 5=very good) with a minimum score of 14 (better outcome) and a maximum score of 70 (worse outcome). | Posted | Mean | Standard Error | points | Baseline and Day 42 |
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| Other Pre-specified | Patients Achieving Remission | The number of subjects achieving remission. Remission was defined as a score of mild or less (≤ 3) for items P1, P2, P3, N1, N4, N6, G5, and G9 in the PANSS score. | Posted | Number | participants | Baseline and Day 42 |
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Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
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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 10 mg/Day Group | Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25 | 4 | 100 | 71 | 100 | ||
| EG001 | Aripiprazole 30 mg/Day Group | Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25 | 4 | 102 | 74 | 102 | ||
| EG002 | Placebo Group | Participants were given a single pill administered once daily | 3 | 100 | 57 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Varicella | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment | Event did not meet the criteria for neuroleptic syndrome |
|
| Aggression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaretta Nyilas | Otsuka Pharmaceutical Development & Commercialization, Inc. | 609-452-5673 | Margaretta.nyilas@otsuka-us.com |
| 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 |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 95 |
| No |
| Superiority or Other |
| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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