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A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01942148
Recruitment Status : Completed
First Posted : September 13, 2013
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Aripiprazole
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 68
Completed 41
Not Completed 27
Reason Not Completed
Adverse Event             4
Lack of Efficacy             2
Physician Decision             11
Protocol Violation             1
Withdrawal by Subject             8
Use of the prohibition medicine             1
Arm/Group Title Aripiprazole
Hide Arm/Group Description 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 Number of Baseline Participants 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
<=18 years
68
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants
15.1  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
31
  45.6%
Male
37
  54.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 68 participants
68
1.Primary Outcome
Title Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
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 Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.9  (28.2)
2.Secondary Outcome
Title Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
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 Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (1.1)
3.Secondary Outcome
Title Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
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 Number of Participants Analyzed 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.6  (19.8)
Time Frame From the start date of screening examination to date of the final examination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole
Hide Arm/Group Description 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.
All-Cause Mortality
Aripiprazole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole
Affected / at Risk (%) # Events
Total   7/68 (10.29%)    
Injury, poisoning and procedural complications   
Intentional overdose  1  1/68 (1.47%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/68 (1.47%)  1
Psychiatric disorders   
Delusion  1  1/68 (1.47%)  1
Hallucination  1  1/68 (1.47%)  1
Schizophrenia  1  5/68 (7.35%)  5
Suicidal ideation  1  1/68 (1.47%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA/J Ver. 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole
Affected / at Risk (%) # Events
Total   61/68 (89.71%)    
Gastrointestinal disorders   
Dental caries  1  5/68 (7.35%)  5
Nausea  1  12/68 (17.65%)  15
Vomiting  1  11/68 (16.18%)  26
Infections and infestations   
Gastroenteritis  1  4/68 (5.88%)  4
Influenza  1  4/68 (5.88%)  4
Nasopharyngitis  1  31/68 (45.59%)  43
Otitis externa  1  4/68 (5.88%)  4
Injury, poisoning and procedural complications   
Excoriation  1  4/68 (5.88%)  4
Contusion  1  5/68 (7.35%)  8
Investigations   
Weight decreased  1  4/68 (5.88%)  4
Weight increased  1  8/68 (11.76%)  8
Nervous system disorders   
Akathisia  1  8/68 (11.76%)  10
Headache  1  9/68 (13.24%)  10
Somnolence  1  14/68 (20.59%)  15
Tremor  1  6/68 (8.82%)  6
Psychiatric disorders   
Insomnia  1  5/68 (7.35%)  8
Schizophrenia  1  6/68 (8.82%)  6
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  5/68 (7.35%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA/J Ver. 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Trials
Organization: Otsuka Pharmaceutical Co., Ltd
Phone: +81-3-6361-7366
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01942148     History of Changes
Other Study ID Numbers: 031-09-004
JapicCTI-101147 ( Other Identifier: JAPIC )
First Submitted: September 10, 2013
First Posted: September 13, 2013
Results First Submitted: December 27, 2016
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017