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A Double-blind, Placebo-controlled Study of the Safety and Efficacy of Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in Adolescent Patients

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00518323
First received: August 16, 2007
Last updated: May 17, 2011
Last verified: November 2010
History of Changes
Results First Received: March 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Paliperidone ER
Drug: Placebo

  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
Recruitment started 8 August 2007 in medical clinics located around the world. The study ended on 30 March 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who were eligible for the study had their current disallowed psychotropic medications washed out prior to assignment to treatment groups. Subjects who violated inclusion criteria before assignment (eg, because they continued to take a disallowed medication) were to be removed from the study.

Reporting Groups
  Description
Pali ER Low Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
Pali ER Medium Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
Pali ER High Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
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Participant Flow:   Overall Study
    Pali ER Low     Pali ER Medium     Pali ER High     Placebo  
STARTED     54     48     48     51  
COMPLETED     35     40     37     26  
NOT COMPLETED     19     8     11     25  
Lack of Efficacy                 14                 2                 4                 20  
Withdrawal by Subject                 1                 2                 4                 2  
Lost to Follow-up                 0                 2                 1                 3  
Adverse Event                 1                 1                 1                 0  
Prohibited medication and others                 3                 1                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Pali ER Low Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
Pali ER Medium Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
Pali ER High Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Pali ER Low     Pali ER Medium     Pali ER High     Placebo     Total  
Number of Participants  
[units: participants]
 		  54     48     48     51     201  
Age  
[units: participants]
 		         
<=18 years     54     48     48     51     201  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  15.1  ± 1.50     15.3  ± 1.60     15.5  ± 1.60     15.7  ± 1.40     15.4  ± 1.53  
Gender  
[units: participants]
 		         
Female     24     17     14     28     83  
Male     30     31     34     23     118  
Region of Enrollment  
[units: participants]
 		         
United States     8     6     7     9     30  
Ukraine     9     8     9     8     34  
Romania     2     3     3     2     10  
Russian Federation     22     20     19     21     82  
India     13     11     10     11     45  



  Outcome Measures
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1.  Primary:   Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study.   [ Time Frame: 6 weeks ]
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2.  Secondary:   Change From Baseline to End Point in Clinical Global Impression-Severity (CGI-S) Scale   [ Time Frame: 6 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline to End Point in Children's Global Assessment (CGAS) Score   [ Time Frame: 6 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep.   [ Time Frame: 6 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline to End Point in Sleep VAS for Daytime Drowsiness   [ Time Frame: 6 weeks ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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 information about longer-term (ie, >6 weeks) efficacy and safety in adolescents or in young (<12 years) children with schizophrenia. Results with doses less than 1.5 mg or more than 12 mg cannot be extrapolated from the data.  


Results Point of Contact:  
Name/Title: Compound Development Team Leader (CDTL)
Organization: Johnson & Johnson Pharmaceutical Research & Development
phone: 609-730-4530


No publications provided


Responsible Party: Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00518323     History of Changes
Other Study ID Numbers: CR002368, R076477PSZ3001
Study First Received: August 16, 2007
Results First Received: March 23, 2010
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration