Trial Outcomes & Findings for A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia (NCT NCT01942148)
NCT ID: NCT01942148
Last Updated: 2017-06-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
68 participants
Primary outcome timeframe
Basline and Week52
Results posted on
2017-06-28
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Physician Decision
|
11
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Use of the prohibition medicine
|
1
|
Baseline Characteristics
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=68 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
68 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
15.1 years
STANDARD_DEVIATION 1.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
|
Region of Enrollment
Japan
|
68 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Basline and Week52The 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.
Outcome measures
| Measure |
Aripiprazole
n=68 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: Basline and Week52The 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.
Outcome measures
| Measure |
Aripiprazole
n=68 Participants
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.
|
|---|---|
|
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
|
SECONDARY outcome
Timeframe: Baseline and Week52The 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.
Outcome measures
| Measure |
Aripiprazole
n=68 Participants
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.
|
|---|---|
|
Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)
|
5.6 units on a scale
Standard Deviation 19.8
|
Adverse Events
Aripiprazole
Serious events: 7 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole
n=68 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Intentional overdose
|
1.5%
1/68 • Number of events 1 • From the start date of screening examination to date of the final examination
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
1/68 • Number of events 1 • From the start date of screening examination to date of the final examination
|
|
Psychiatric disorders
Delusion
|
1.5%
1/68 • Number of events 1 • From the start date of screening examination to date of the final examination
|
|
Psychiatric disorders
Hallucination
|
1.5%
1/68 • Number of events 1 • From the start date of screening examination to date of the final examination
|
|
Psychiatric disorders
Schizophrenia
|
7.4%
5/68 • Number of events 5 • From the start date of screening examination to date of the final examination
|
|
Psychiatric disorders
Suicidal ideation
|
1.5%
1/68 • Number of events 1 • From the start date of screening examination to date of the final examination
|
Other adverse events
| Measure |
Aripiprazole
n=68 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Dental caries
|
7.4%
5/68 • Number of events 5 • From the start date of screening examination to date of the final examination
|
|
Gastrointestinal disorders
Nausea
|
17.6%
12/68 • Number of events 15 • From the start date of screening examination to date of the final examination
|
|
Gastrointestinal disorders
Vomiting
|
16.2%
11/68 • Number of events 26 • From the start date of screening examination to date of the final examination
|
|
Infections and infestations
Gastroenteritis
|
5.9%
4/68 • Number of events 4 • From the start date of screening examination to date of the final examination
|
|
Infections and infestations
Influenza
|
5.9%
4/68 • Number of events 4 • From the start date of screening examination to date of the final examination
|
|
Infections and infestations
Nasopharyngitis
|
45.6%
31/68 • Number of events 43 • From the start date of screening examination to date of the final examination
|
|
Infections and infestations
Otitis externa
|
5.9%
4/68 • Number of events 4 • From the start date of screening examination to date of the final examination
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.9%
4/68 • Number of events 4 • From the start date of screening examination to date of the final examination
|
|
Injury, poisoning and procedural complications
Contusion
|
7.4%
5/68 • Number of events 8 • From the start date of screening examination to date of the final examination
|
|
Investigations
Weight decreased
|
5.9%
4/68 • Number of events 4 • From the start date of screening examination to date of the final examination
|
|
Nervous system disorders
Akathisia
|
11.8%
8/68 • Number of events 10 • From the start date of screening examination to date of the final examination
|
|
Investigations
Weight increased
|
11.8%
8/68 • Number of events 8 • From the start date of screening examination to date of the final examination
|
|
Nervous system disorders
Headache
|
13.2%
9/68 • Number of events 10 • From the start date of screening examination to date of the final examination
|
|
Nervous system disorders
Somnolence
|
20.6%
14/68 • Number of events 15 • From the start date of screening examination to date of the final examination
|
|
Nervous system disorders
Tremor
|
8.8%
6/68 • Number of events 6 • From the start date of screening examination to date of the final examination
|
|
Psychiatric disorders
Insomnia
|
7.4%
5/68 • Number of events 8 • From the start date of screening examination to date of the final examination
|
|
Psychiatric disorders
Schizophrenia
|
8.8%
6/68 • Number of events 6 • From the start date of screening examination to date of the final examination
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.4%
5/68 • Number of events 7 • From the start date of screening examination to date of the final examination
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., Ltd
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place