Schizophrenia
Conditions
Keywords
Schizophrenia, Pediatric patients
Brief summary
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).
Interventions
DRUGAripiprazole
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-IV-TR * Male and female patients aged 13-17 years * Patients completing the 031-09-003 study * Patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study * Inpatient or outpatient status
Exclusion criteria
* Patients who have a diagnosis of any other disease except schizophrenia, according to DSM-IV-TR * Patients who have been compulsorily admitted to hospital * Patients with mental retardation * Patients with thyroid disorder * Patients who fall under a contraindication listed in the ABILIFY package insert * Patients with a serious hepatic, renal, cardiac or hematopoietic disorder * Patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy * Patients with a history or a complication of diabetes and patients who fall under any of the following: fasting blood glucose level ≧ 126 mg/dL, non-fasting blood glucose level ≧ 200 mg/dL, HbA1c ≧ 6.5% * Patients with a history or a complication of suicide attempt, suicidal thought or self-harm * Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS * Patients with a history or a complication of malignant syndrome, tardive dyskinesia or paralytic ileus * Patients in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition * Patients with a history or a complication of water intoxication * Patients with Parkinson's disease * Pregnant women, parturient women, nursing women, women of childbearing potential who wish to become pregnant during this trial. However, women of childbearing potential who are practicing an appropriate method of contraception (refer to 8.6) and have a negative pregnancy test result are eligible for inclusion in this study. * Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score | Basline and Week52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score | Basline and Week52 | 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. |
| Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS) | Baseline and Week52 | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Physician Decision | 11 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Use of the prohibition medicine | 1 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Aripiprazole |
|---|---|
| Age, Categorical <=18 years | 68 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 15.1 years STANDARD_DEVIATION 1.4 |
| Region of Enrollment Japan | 68 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 61 / 68 |
| serious Total, serious adverse events | 7 / 68 |
Outcome results
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.
Time frame: Basline and Week52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aripiprazole | Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score | -7.9 units on a scale | Standard Deviation 28.2 |
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.
Time frame: Baseline and Week52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aripiprazole | Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS) | 5.6 units on a scale | Standard Deviation 19.8 |
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.
Time frame: Basline and Week52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aripiprazole | Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score | -0.3 units on a scale | Standard Deviation 1.1 |