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The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCT00102063 and NCT00110461 Subjects | Experimental | All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | 2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Experiencing SAEs | Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity. | Baseline and Week 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score | Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26). 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Birmingham | Alabama | United States | |||
| Local Institution |
All participants had previously completed NCT00102063 (OPDC 31-03-239, adolescents with schizophrenia) or had withdrawn from the double-blind extension phase of NCT00110461 (OPDC 31-03-240, children and adolescents with bipolar 1 disorder), both clinical studies of aripiprazole.
Participants were recruited from 157 centers in Argentina, Bulgaria, Croatia, India, Jamaica, Mexico, Romania, Russia, Serbia, South Africa, South Korea, Ukraine, and the United States between September 2004 and February 2007. A total of 325 subjects were screened for enrollment and all 325 subjects were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | NCT00102063 and NCT00110461 Subjects | All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Baseline and Week 26 |
| Change in Young Mania Rating Scale (Y-MRS) Total Score | Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26). The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms). | Baseline and Week 26 |
| Little Rock |
| Arkansas |
| United States |
| Local Institution | Costa Mesa | California | United States |
| Local Institution | Fresno | California | United States |
| Local Institution | Orange | California | United States |
| Local Institution | Riverside | California | United States |
| Local Institution | Rosemead | California | United States |
| Local Institution | Sacramento | 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 | Hialeah | Florida | United States |
| Local Institution | Jacksonville | Florida | United States |
| Local Institution | Miami | Florida | United States |
| Local Institution | Orange City | Florida | United States |
| Local Institution | Tampa | Florida | United States |
| Local Institution | Atlanta | 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 | Louisville | Kentucky | United States |
| Local Institution | Lake Charles | Louisiana | United States |
| Local Institution | Metairie | Louisiana | United States |
| Local Institution | New Orleans | Louisiana | United States |
| Local Institution | Somerville | Massachusetts | United States |
| Local Institution | Clinton | Michigan | United States |
| Local Institution | Kansas City | Missouri | United States |
| Local Institution | Saint Charles | Missouri | 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 | Kirkland | Washington | United States |
| Local Institution | Seattle | Washington | United States |
| Local Institution | Spokane | Washington | United States |
| Local Institution | Wauwatosa | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NCT00102063 and NCT00110461 Subjects | All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239. |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Percentage of Subjects Experiencing SAEs | Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity. | All enrolled subjects. | Posted | Number | percentage of participants | Baseline and Week 23 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score | Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26). 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 Deviation | points | Baseline and Week 26 |
|
| |||||||||||||||||||||||||||
| Secondary | Change in Young Mania Rating Scale (Y-MRS) Total Score | Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26). The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms). | Posted | Mean | Standard Deviation | points | Baseline and Week 26 |
|
|
Adverse event data were collected as spontaneous reports at all scheduled visit. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.
Spontaneously reported at each visit in response to query of "How have you felt since your last assessment?"
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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 | NCT00102063 and NCT00110461 Subjects | All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239. | 20 | 325 | 230 | 325 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis acute | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Electrocution | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Impulsive behavior | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Intentional self injury | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| 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 |
|
| 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 |
| |
| Weight increased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Akathisia | 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 |
| |
| 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 |
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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