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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Aripiprazole
STARTED   68 
COMPLETED   41 
NOT COMPLETED   27 
Adverse Event                4 
Lack of Efficacy                2 
Physician Decision                11 
Protocol Violation                1 
Withdrawal by Subject                8 
Use of the prohibition medicine                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Aripiprazole 
Overall Participants Analyzed 
[Units: Participants]
 68 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      68 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.1  (1.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      31  45.6% 
Male      37  54.4% 
Region of Enrollment 
[Units: Participants]
 
Japan   68 


  Outcome Measures

1.  Primary:   Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: Basline and Week52 ]

2.  Secondary:   Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score   [ Time Frame: Basline and Week52 ]

3.  Secondary:   Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)   [ Time Frame: Baseline and Week52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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