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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.
Enrollment 1429
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation
Hide Arm/Group Description 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. 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. 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.
Period Title: Open Label Phase
Started 1429 0 0
Completed 1016 0 0
Not Completed 413 0 0
Reason Not Completed
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 Title: DOUBLE BLIND
Started 0 504 512
Completed 0 422 420
Not Completed 0 82 92
Reason Not Completed
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
Arm/Group Title Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 504 512 1016
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 504 participants 512 participants 1016 participants
39.0  (11.89) 38.3  (12.24) 38.6  (12.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 504 participants 512 participants 1016 participants
Female
246
  48.8%
231
  45.1%
477
  46.9%
Male
258
  51.2%
281
  54.9%
539
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 504 participants 512 participants 1016 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
1.Primary Outcome
Title Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase
Hide Description Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.
Time Frame Up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Double Blind: Paliperidone Palmitate 3 Month Formulation Double Blind: Paliperidone Palmitate 1 Month Formulation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 458 490
Measure Type: Number
Unit of Measure: Percentage of Participants
91.5 90.0
2.Secondary Outcome
Title Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
Hide Description The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).
Time Frame DB Baseline (Week 17) and 48 week or DB Endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Double Blind: Paliperidone Palmitate 3 Month Formulation Double Blind: Paliperidone Palmitate 1 Month Formulation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 481 503
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 57.4  (8.56) 58.1  (8.88)
Change from Baseline at DB End point -3.5  (12.50) -4.3  (11.78)
3.Secondary Outcome
Title Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48
Hide Description The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Time Frame DB Baseline (Week 17) and 48 week or DB Endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Double Blind: Paliperidone Palmitate 3 Month Formulation Double Blind: Paliperidone Palmitate 1 Month Formulation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 481 504
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.9  (0.57) 2.9  (0.66)
Change from Baseline at DB End point -0.1  (0.84) -0.1  (0.75)
4.Secondary Outcome
Title Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48
Hide Description The Personal and Social Performance (PSP) scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
Time Frame DB Baseline (Week 17) and 48 week or DB Endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Double Blind: Paliperidone Palmitate 3 Month Formulation Double Blind: Paliperidone Palmitate 1 Month Formulation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 474 495
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 65.5  (10.40) 65.0  (11.06)
Change from Baseline at DB End point 1.3  (10.22) 1.9  (9.21)
5.Secondary Outcome
Title Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria
Hide Description Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.
Time Frame Weeks 41 to 65
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Double Blind: Paliperidone Palmitate 3 Month Formulation Double Blind: Paliperidone Palmitate 1 Month Formulation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 483 512
Measure Type: Number
Unit of Measure: Percentage of Participants
58.4 59.2
6.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48
Hide Description The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).
Time Frame DB Baseline (Week 17) and 48 week or DB Endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Double Blind: Paliperidone Palmitate 3 Month Formulation Double Blind: Paliperidone Palmitate 1 Month Formulation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 483 512
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Positive subscale: Baseline 11.9  (3.12) 12.0  (3.19)
Positive subscale:Change at Endpoint -0.6  (4.31) -0.9  (3.70)
Negative subscale: Baseline 17.3  (4.27) 17.3  (4.11)
Negative subscale:Change at Endpoint -1.4  (3.63) -1.4  (3.67)
General psychopathology : Baseline 28.2  (4.55) 28.8  (4.79)
General psychopathology : Change at Endpoint -1.4  (6.77) -2.0  (6.57)
7.Secondary Outcome
Title Change From Baseline in Marder Factor Subscale Score at Week 48
Hide Description 5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.
Time Frame DB Baseline (Week 17) and 48 week or DB Endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
Arm/Group Title Double Blind: Paliperidone Palmitate 3 Month Formulation Double Blind: Paliperidone Palmitate 1 Month Formulation
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 483 512
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Positive symptoms factor: Baseline 15.7  (3.66) 15.8  (3.88)
Positive symptoms factor:Change at Endpoint -1.1  (4.61) -1.4  (4.16)
Negative symptoms factor: Baseline 16.2  (4.03) 16.3  (3.90)
Negative symptoms factor : Change at Endpoint -1.4  (3.57) -1.3  (3.80)
Disorganized thoughts factor :Baseline 14.2  (3.20) 14.3  (3.17)
Disorganized thoughts factor:Change at Endpoint -1.2  (3.36) -1.2  (3.24)
Uncontrolled hostility Factor:Baseline 5.2  (1.64) 5.4  (1.77)
Uncontrolled hostility Factor:Change at Endpoint 0.2  (2.31) -0.2  (2.21)
Anxiety/depression factor:Baseline 6.1  (2.02) 6.3  (2.12)
Anxiety/depression factor:Change at Endpoint -0.0  (2.69) -0.2  (2.43)
Time Frame From signing of informed consent form up to Follow-Up Visit (4 or 12 Weeks after study drug administration)
Adverse Event Reporting Description For Double-blind (DB) phase, safety analysis set included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study drug. For Open-label Phase, all participants who received at least 1 dose of open-label study drug and were included in summary of safety assessments for that phase.
 
Arm/Group Title Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   101/1429 (7.07%)   26/504 (5.16%)   37/512 (7.23%) 
Blood and lymphatic system disorders       
Pancytopenia * 1  0/1429 (0.00%)  0/504 (0.00%)  1/512 (0.20%) 
Thrombocytopenia * 1  0/1429 (0.00%)  1/504 (0.20%)  0/512 (0.00%) 
Cardiac disorders       
Cardiac Arrest * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Ear and labyrinth disorders       
Vertigo * 1  0/1429 (0.00%)  0/504 (0.00%)  1/512 (0.20%) 
Gastrointestinal disorders       
Gastrointestinal Disorder * 1  0/1429 (0.00%)  0/504 (0.00%)  1/512 (0.20%) 
Haemorrhoids * 1  0/1429 (0.00%)  0/504 (0.00%)  1/512 (0.20%) 
Pancreatitis Acute * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Vomiting * 1  2/1429 (0.14%)  0/504 (0.00%)  0/512 (0.00%) 
General disorders       
Chest Pain * 1  0/1429 (0.00%)  0/504 (0.00%)  1/512 (0.20%) 
Drug Ineffective * 1  2/1429 (0.14%)  0/504 (0.00%)  0/512 (0.00%) 
Drug Withdrawal Syndrome * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Immune system disorders       
Hypersensitivity * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Infections and infestations       
Diverticulitis * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Meningitis Bacterial * 1  0/1429 (0.00%)  0/504 (0.00%)  1/512 (0.20%) 
Pyelonephritis Acute * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Injury, poisoning and procedural complications       
Alcohol Poisoning * 1  0/1429 (0.00%)  1/504 (0.20%)  0/512 (0.00%) 
Head Injury * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Meniscus Injury * 1  0/1429 (0.00%)  1/504 (0.20%)  0/512 (0.00%) 
Overdose * 1  2/1429 (0.14%)  0/504 (0.00%)  0/512 (0.00%) 
Toxicity to Various Agents * 1  1/1429 (0.07%)  0/504 (0.00%)  1/512 (0.20%) 
Metabolism and nutrition disorders       
Diabetes Mellitus * 1  1/1429 (0.07%)  1/504 (0.20%)  0/512 (0.00%) 
Diabetic Ketoacidosis * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Hyponatraemia * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Musculoskeletal and connective tissue disorders       
Muscle Rigidity * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Osteoarthritis * 1  0/1429 (0.00%)  1/504 (0.20%)  0/512 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatocellular Carcinoma * 1  0/1429 (0.00%)  1/504 (0.20%)  0/512 (0.00%) 
Neoplasm Prostate * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Prostate Cancer * 1  0/1429 (0.00%)  1/504 (0.20%)  0/512 (0.00%) 
Nervous system disorders       
Akathisia * 1  4/1429 (0.28%)  0/504 (0.00%)  0/512 (0.00%) 
Dyskinesia * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Somnolence * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Stupor * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Syncope * 1  0/1429 (0.00%)  0/504 (0.00%)  1/512 (0.20%) 
Psychiatric disorders       
Acute Psychosis * 1  2/1429 (0.14%)  0/504 (0.00%)  0/512 (0.00%) 
Adjustment Disorder * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Agitation * 1  1/1429 (0.07%)  0/504 (0.00%)  1/512 (0.20%) 
Alcohol Abuse * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Anxiety * 1  4/1429 (0.28%)  0/504 (0.00%)  2/512 (0.39%) 
Anxiety Disorder * 1  2/1429 (0.14%)  1/504 (0.20%)  0/512 (0.00%) 
Delusion * 1  4/1429 (0.28%)  1/504 (0.20%)  2/512 (0.39%) 
Depressed Mood * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Depression * 1  2/1429 (0.14%)  1/504 (0.20%)  0/512 (0.00%) 
Hallucination * 1  1/1429 (0.07%)  0/504 (0.00%)  1/512 (0.20%) 
Hallucination, Auditory * 1  6/1429 (0.42%)  1/504 (0.20%)  0/512 (0.00%) 
Hostility * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Hypomania * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Insomnia * 1  2/1429 (0.14%)  0/504 (0.00%)  0/512 (0.00%) 
Irritability * 1  3/1429 (0.21%)  0/504 (0.00%)  0/512 (0.00%) 
Neurosis * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Persecutory Delusion * 1  1/1429 (0.07%)  0/504 (0.00%)  1/512 (0.20%) 
Psychiatric Symptom * 1  4/1429 (0.28%)  2/504 (0.40%)  2/512 (0.39%) 
Psychotic Disorder * 1  14/1429 (0.98%)  1/504 (0.20%)  2/512 (0.39%) 
Restlessness * 1  0/1429 (0.00%)  0/504 (0.00%)  1/512 (0.20%) 
Schizophrenia * 1  31/1429 (2.17%)  12/504 (2.38%)  11/512 (2.15%) 
Schizophrenia, Paranoid Type * 1  0/1429 (0.00%)  0/504 (0.00%)  2/512 (0.39%) 
Self Injurious Behaviour * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Substance-Induced Psychotic Disorder * 1  2/1429 (0.14%)  0/504 (0.00%)  1/512 (0.20%) 
Suicidal Ideation * 1  6/1429 (0.42%)  0/504 (0.00%)  0/512 (0.00%) 
Suicide Attempt * 1  3/1429 (0.21%)  0/504 (0.00%)  4/512 (0.78%) 
Tension * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Renal and urinary disorders       
Calculus Ureteric * 1  0/1429 (0.00%)  0/504 (0.00%)  1/512 (0.20%) 
Reproductive system and breast disorders       
Menstrual Disorder * 1  0/1429 (0.00%)  1/504 (0.20%)  0/512 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pneumothorax * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Vascular disorders       
Arteriosclerosis * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Hypertension * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Peripheral Artery Thrombosis * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
Thrombosis * 1  1/1429 (0.07%)  0/504 (0.00%)  0/512 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   457/1429 (31.98%)   212/504 (42.06%)   208/512 (40.63%) 
General disorders       
Injection Site Induration * 1  40/1429 (2.80%)  14/504 (2.78%)  6/512 (1.17%) 
Injection Site Pain * 1  127/1429 (8.89%)  12/504 (2.38%)  14/512 (2.73%) 
Infections and infestations       
Nasopharyngitis * 1  66/1429 (4.62%)  36/504 (7.14%)  33/512 (6.45%) 
Investigations       
Weight Decreased * 1  10/1429 (0.70%)  14/504 (2.78%)  14/512 (2.73%) 
Weight Increased * 1  64/1429 (4.48%)  105/504 (20.83%)  109/512 (21.29%) 
Nervous system disorders       
Akathisia * 1  78/1429 (5.46%)  20/504 (3.97%)  14/512 (2.73%) 
Headache * 1  46/1429 (3.22%)  18/504 (3.57%)  26/512 (5.08%) 
Psychiatric disorders       
Anxiety * 1  79/1429 (5.53%)  27/504 (5.36%)  22/512 (4.30%) 
Insomnia * 1  94/1429 (6.58%)  16/504 (3.17%)  24/512 (4.69%) 
Vascular disorders       
Hypertension * 1  11/1429 (0.77%)  12/504 (2.38%)  7/512 (1.37%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 17.1
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.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: Director Clinical Research
Organization: Janssen Research & Development, LLC
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