An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01009047
First received: November 5, 2009
Last updated: June 20, 2013
Last verified: June 2013
Results First Received: March 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Paliperidone extended release (ER)
Drug: Aripiprazole

  Participant Flow
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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
Paliperidone Extended Release (ER) Paliperidone ER administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.

Participant Flow:   Overall Study
    Paliperidone Extended Release (ER)     Aripiprazole  
STARTED     113     115  
COMPLETED     85     89  
NOT COMPLETED     28     26  
Adverse Event                 5                 0  
Lost to Follow-up                 0                 2  
Lack of Efficacy                 4                 11  
Withdrawal by consent                 16                 11  
Unspecified                 3                 2  



  Baseline Characteristics
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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
Paliperidone Extended Release (ER) Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
Aripiprazole Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Total Total of all reporting groups

Baseline Measures
    Paliperidone Extended Release (ER)     Aripiprazole     Total  
Number of Participants  
[units: participants]
  112     114     226  
Age [1]
[units: Years]
Mean ± Standard Deviation
  15.3  ± 1.46     15.4  ± 1.45     15.3  ± 1.46  
Gender [1]
[units: Participants]
     
Female     39     38     77  
Male     73     76     149  
[1] Number of participants analyzed for this Baseline characteristic is intent to treat (ITT) population which included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.



  Outcome Measures
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1.  Primary:   Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56   [ Time Frame: Baseline and Day 56 ]

2.  Secondary:   Change From Baseline in PANSS Total Score at Day 182   [ Time Frame: Baseline and Day 182 ]

3.  Secondary:   Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182   [ Time Frame: Baseline, Day 56 and Day 182 ]

4.  Secondary:   Change From Baseline in Other Marder Factors Scores at Day 56 and 182   [ Time Frame: Baseline, Day 56 and 182 ]

5.  Secondary:   Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182   [ Time Frame: Baseline, Day 56 and 182 ]

6.  Secondary:   Number of Participants With Clinical Stability   [ Time Frame: Day 56 and 182 ]

7.  Secondary:   Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182   [ Time Frame: Baseline, Day 56 and 182 ]

8.  Secondary:   Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182   [ Time Frame: Baseline, Day 56 and Day 182 ]

9.  Secondary:   Number of Participants With PANSS Response   [ Time Frame: Day 56 and 182 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Director, Clinical Leader
Organization: Janssen Research & Development, LLC
phone: +1-609-730-2436


No publications provided


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01009047     History of Changes
Other Study ID Numbers: CR016675, R076477PSZ3003
Study First Received: November 5, 2009
Results First Received: March 29, 2013
Last Updated: June 20, 2013
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health