Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00488319
First received: June 18, 2007
Last updated: November 12, 2013
Last verified: November 2013
Results First Received: July 12, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizophrenic Disorders
Psychotic Disorders
Dementia Praecox.
Intervention: Drug: Paliperidone ER

  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
This study evaluated the long-term (2 year) safety and tolerability of paliperidone extended release (ER) in adolescent patients with schizophrenia. This study was conducted from 27 June 2007 to 18 July 2012 at 55 centers in 10 countries. A total of 400 patients received at least 1 dose of the study drug and were included in the safety analysis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients enrolled in this study came from 3 different sources: patients who enrolled directly, patients who were randomly assigned to placebo in the R076477PSZ3001 (NCT00518323) study, and patients who were randomly assigned to paliperidone ER in the R076477PSZ3001 (NCT00518323) study.

Reporting Groups
  Description
Placebo/Paliperidone Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
Paliperidone (Double-blind)/Paliperidone Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
Paliperidone (No Double-blind)/Paliperidone Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.

Participant Flow:   Overall Study
    Placebo/Paliperidone     Paliperidone (Double-blind)/Paliperidone     Paliperidone (No Double-blind)/Paliperidone  
STARTED     39     118     243  
COMPLETED     24     75     121  
NOT COMPLETED     15     43     122  
Adverse Event                 1                 2                 23  
Lack of Efficacy                 6                 12                 27  
Lost to Follow-up                 3                 5                 16  
Withdrawal by Subject                 5                 20                 44  
Other reasons for withdrawal                 0                 4                 12  



  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
Placebo/Paliperidone Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
Paliperidone (Double-blind)/Paliperidone Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
Paliperidone (No Double-blind)/Paliperidone Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
Total Total of all reporting groups

Baseline Measures
    Placebo/Paliperidone     Paliperidone (Double-blind)/Paliperidone     Paliperidone (No Double-blind)/Paliperidone     Total  
Number of Participants  
[units: participants]
  39     118     243     400  
Age  
[units: participants]
       
<=18 years     39     118     243     400  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  15.8  ± 1.48     15.3  ± 1.59     15.3  ± 1.53     15.4  ± 1.55  
Gender  
[units: participants]
       
Female     21     44     92     157  
Male     18     74     151     243  
Region of Enrollment  
[units: participants]
       
Bulgaria     0     0     6     6  
Estonia     0     0     3     3  
Finland     0     0     3     3  
India     6     23     35     64  
Korea     0     0     40     40  
Poland     0     0     47     47  
Romania     2     8     10     20  
Russia     18     51     40     109  
Ukraine     8     22     18     48  
United States of America     5     14     41     60  



  Outcome Measures
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1.  Primary:   The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Up to 2 years ]

2.  Secondary:   Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward   [ Time Frame: Baseline, Week 104 or the last post-baseline assessment ]

3.  Secondary:   Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward   [ Time Frame: Baseline, Week 104 or the last post-baseline assessment ]

4.  Secondary:   Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward   [ Time Frame: Baseline, Week 104 or the last post-baseline assessment ]

5.  Secondary:   Change From Open-label Baseline to Open-label Endpoint in the Children’s Global Assessment Scale (CGAS) - Last Observation Carried Forward   [ Time Frame: Baseline, Week 104 or the last post-baseline assessment ]

6.  Secondary:   Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

7.  Secondary:   Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

8.  Secondary:   Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

9.  Secondary:   Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

10.  Secondary:   Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

11.  Secondary:   Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

12.  Secondary:   Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

13.  Secondary:   Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

14.  Secondary:   Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

15.  Secondary:   Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

16.  Secondary:   Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

17.  Secondary:   Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

18.  Secondary:   Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward   [ Time Frame: Baseline, Week 24 ]

19.  Secondary:   Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward   [ Time Frame: Baseline, Week 104 or the last post-baseline assessment ]

20.  Secondary:   Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward   [ Time Frame: Baseline, Week 104 or the last post-baseline assessment ]


  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: Director Clinical Research
Organization: Johnson & Johnson Research & Development, LLC
phone: 1-609-730-6771


No publications provided


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00488319     History of Changes
Other Study ID Numbers: CR012616, R076477PSZ3002
Study First Received: June 18, 2007
Results First Received: July 12, 2013
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health