An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01662310
First received: March 29, 2012
Last updated: September 15, 2014
Last verified: September 2014
Results First Received: April 30, 2014  
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
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
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: Run-in or Stabilization Phase Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 milligram per day (mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
Paliperidone: Double Blind (DB) Phase Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
Placebo: DB Phase Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
Paliperidone DB/Paliperidone Open-label (OL) Extension Phase Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
Placebo DB/Paliperidone OL Extension Phase Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.

Participant Flow for 3 periods

Period 1:   Run-In or Stabilization Phase
    Paliperidone: Run-in or Stabilization Phase     Paliperidone: Double Blind (DB) Phase     Placebo: DB Phase     Paliperidone DB/Paliperidone Open-label (OL) Extension Phase     Placebo DB/Paliperidone OL Extension Phase  
STARTED     201     0     0     0     0  
COMPLETED     136     0     0     0     0  
NOT COMPLETED     65     0     0     0     0  
Adverse Event                 11                 0                 0                 0                 0  
Lack of Efficacy                 9                 0                 0                 0                 0  
Lost to Follow-up                 4                 0                 0                 0                 0  
Protocol Violation                 15                 0                 0                 0                 0  
Withdrawal by Subject                 25                 0                 0                 0                 0  
unspecified                 1                 0                 0                 0                 0  

Period 2:   Double-Blind Phase
    Paliperidone: Run-in or Stabilization Phase     Paliperidone: Double Blind (DB) Phase     Placebo: DB Phase     Paliperidone DB/Paliperidone Open-label (OL) Extension Phase     Placebo DB/Paliperidone OL Extension Phase  
STARTED     0     65     71     0     0  
Treated     0     64     71     0     0  
COMPLETED     0     50     66     0     0  
NOT COMPLETED     0     15     5     0     0  
Adverse Event                 0                 0                 1                 0                 0  
Lost to Follow-up                 0                 3                 0                 0                 0  
Pregnancy                 0                 2                 0                 0                 0  
Withdrawal by Subject                 0                 9                 3                 0                 0  
unspecified                 0                 0                 1                 0                 0  
Randomized but not treated                 0                 1                 0                 0                 0  

Period 3:   Open-Label Extension Phase
    Paliperidone: Run-in or Stabilization Phase     Paliperidone: Double Blind (DB) Phase     Placebo: DB Phase     Paliperidone DB/Paliperidone Open-label (OL) Extension Phase     Placebo DB/Paliperidone OL Extension Phase  
STARTED     0     0     0     47     59  
COMPLETED     0     0     0     36     49  
NOT COMPLETED     0     0     0     11     10  
Adverse Event                 0                 0                 0                 3                 0  
Death                 0                 0                 0                 1                 0  
Lack of Efficacy                 0                 0                 0                 2                 2  
Lost to Follow-up                 0                 0                 0                 2                 1  
Pregnancy                 0                 0                 0                 1                 0  
Withdrawal by Subject                 0                 0                 0                 2                 7  



  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
Entire Study Population All the participants who were enrolled.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  201  
Age  
[units: years]
Mean ± Standard Deviation
  31.3  ± 10.52  
Gender  
[units: participants]
 
Female     110  
Male     91  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Double Blind (DB) Phase: Median Time to Relapse   [ Time Frame: DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year) ]

2.  Secondary:   Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14   [ Time Frame: Baseline and Week 14 ]

3.  Secondary:   Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint   [ Time Frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year]) ]

4.  Secondary:   Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)   [ Time Frame: Baseline and Week 14 ]

5.  Secondary:   Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint   [ Time Frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year]) ]

6.  Secondary:   Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14   [ Time Frame: Baseline and Week 14 ]

7.  Secondary:   Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint   [ Time Frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year]) ]

8.  Secondary:   Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14   [ Time Frame: Baseline and Week 14 ]

9.  Secondary:   Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint   [ Time Frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year]) ]

10.  Secondary:   Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14   [ Time Frame: Baseline and Week 14 ]

11.  Secondary:   Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint   [ Time Frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year]) ]

12.  Secondary:   Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)   [ Time Frame: DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year) ]

13.  Secondary:   Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint   [ Time Frame: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint) ]

14.  Secondary:   Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint   [ Time Frame: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint) ]

15.  Secondary:   Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint   [ Time Frame: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint) ]


  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
Independent Data Monitoring Committee (IDMC) conducted an interim analysis after 61st relapse in double-blind (DB) phase and DB phase completed on 09-Nov-2012 based on positive results of interim analysis.


  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: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01662310     History of Changes
Other Study ID Numbers: CR100427, R076477-SCH-3041
Study First Received: March 29, 2012
Results First Received: April 30, 2014
Last Updated: September 15, 2014
Health Authority: China: Food and Drug Administration
China: Ethics Committee