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Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01515423
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: PP3M 175 mg eq.
Drug: PP3M 263 mg eq.
Drug: PP3M 350 mg eq.
Drug: PP3M 525 mg eq.
Drug: Placebo (20% Intralipid)
Drug: PP1M 50 mg eq.
Drug: PP1M 75 mg eq.
Drug: PP1M 100 mg eq.
Drug: PP1M 150 mg eq.

  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
1429 participants received at least 1 dose of the study agent in the Open-label Phase, out of which 1016 participants were randomized into the Double blind Phase (Safety population).

Reporting Groups
  Description
Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.

Participant Flow for 2 periods

Period 1:   Open Label Phase
    Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation   Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation   Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation
STARTED   1429   0   0 
COMPLETED   1016   0   0 
NOT COMPLETED   413   0   0 
Adverse Event                57                0                0 
Death                2                0                0 
Lack of Efficacy                117                0                0 
Lost to Follow-up                21                0                0 
Withdrawal by Subject                118                0                0 
excluded from DB Phase                70                0                0 
Other                28                0                0 

Period 2:   DOUBLE BLIND
    Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation   Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation   Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation
STARTED   0   504   512 
COMPLETED   0   422   420 
NOT COMPLETED   0   82   92 
Adverse Event                0                15                13 
Death                0                1                2 
Lost to Follow-up                0                7                12 
Pregnancy                0                2                0 
Withdrawal by Subject                0                50                53 
Other                0                6                12 
Blind broken by investigator                0                1                0 



  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.
The safety analysis set included all participants who were randomly assigned to treatment during the Double-blind Phase and received at least 1 dose study drug.

Reporting Groups
  Description
Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
Total Total of all reporting groups

Baseline Measures
   Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation   Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation   Total 
Overall Participants Analyzed 
[Units: Participants]
 504   512   1016 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.0  (11.89)   38.3  (12.24)   38.6  (12.06) 
Gender 
[Units: Participants]
     
Female   246   231   477 
Male   258   281   539 
Region of Enrollment 
[Units: Participants]
     
China   104   106   210 
Russian Federation   75   75   150 
Japan   52   56   108 
United States   41   48   89 
Ukraine   35   29   64 
Czech Republic   31   29   60 
Hungary   21   19   40 
Poland   17   20   37 
Argentina   14   16   30 
Bulgaria   12   16   28 
Brazil   13   12   25 
Spain   11   14   25 
Slovakia   12   10   22 
Portugal   11   10   21 
Mexico   7   9   16 
Taiwan   7   7   14 
Romania   7   6   13 
Germany   8   4   12 
South Korea   7   5   12 
Belgium   7   4   11 
Greece   5   6   11 
Canada   3   6   9 
Australia   3   2   5 
France   1   2   3 
Austria   0   1   1 


  Outcome Measures

1.  Primary:   Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase   [ Time Frame: Up to 48 weeks ]

2.  Secondary:   Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48   [ Time Frame: DB Baseline (Week 17) and 48 week or DB Endpoint ]

3.  Secondary:   Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48   [ Time Frame: DB Baseline (Week 17) and 48 week or DB Endpoint ]

4.  Secondary:   Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48   [ Time Frame: DB Baseline (Week 17) and 48 week or DB Endpoint ]

5.  Secondary:   Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria   [ Time Frame: Weeks 41 to 65 ]

6.  Secondary:   Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48   [ Time Frame: DB Baseline (Week 17) and 48 week or DB Endpoint ]

7.  Secondary:   Change From Baseline in Marder Factor Subscale Score at Week 48   [ Time Frame: DB Baseline (Week 17) and 48 week or DB Endpoint ]


  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 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: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01515423     History of Changes
Other Study ID Numbers: CR100662
R092670PSY3011 ( Other Identifier: Janssen Research & Development, LLC )
2011-004889-15 ( EudraCT Number )
U1111-1135-7054 ( Other Identifier: Universal Trial Number )
First Submitted: January 17, 2012
First Posted: January 24, 2012
Results First Submitted: February 1, 2016
Results First Posted: May 2, 2016
Last Update Posted: May 2, 2016