Bipolar Disorder, Schizophrenia
Conditions
Keywords
Open Label, Aripiprazole, Bipolar I Disorder, Manic or Mixed Episode
Brief summary
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.
Interventions
DRUGAripiprazole
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
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode
Exclusion criteria
* Patients with a co-morbid serious, uncontrolled systemic illness * Patients with a significant risk of committing suicide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Experiencing SAEs | Baseline and Week 23 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline and Week 26 | 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. |
| Change in Young Mania Rating Scale (Y-MRS) Total Score | Baseline and Week 26 | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 325 |
| Total | 325 |
Baseline characteristics
| Characteristic | NCT00102063 and NCT00110461 Subjects |
|---|---|
| Age Continuous | 15.02 years STANDARD_DEVIATION 1.89 |
| Body Mass Index (BMI) | 23.25 kg/m^2 STANDARD_DEVIATION 5.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 281 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 164.09 cm STANDARD_DEVIATION 11.22 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 34 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants |
| Race (NIH/OMB) More than one race | 45 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 206 Participants |
| Sex: Female, Male Female | 140 Participants |
| Sex: Female, Male Male | 185 Participants |
| Weight | 63.19 kg STANDARD_DEVIATION 17.86 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 230 / 325 |
| serious Total, serious adverse events | 20 / 325 |
Outcome results
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.
Time frame: Baseline and Week 23
Population: All enrolled subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NCT00102063 and NCT00110461 Subjects | Percentage of Subjects Experiencing SAEs | 6.2 percentage of participants |
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.
Time frame: Baseline and Week 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NCT00102063 and NCT00110461 Subjects | Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score | -7.5 points | Standard Deviation 17.89 |
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).
Time frame: Baseline and Week 26
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NCT00102063 and NCT00110461 Subjects | Change in Young Mania Rating Scale (Y-MRS) Total Score | -7.74 points | Standard Deviation 11.73 |