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    Clinical Trial Results:
    A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects with Schizophrenia

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2011-004889-15
    Trial protocol
    CZ   ES   BE   DE   PT   AT   HU   SE   DK   SK   FI   GR   BG  
    Global end of trial date
    02 Mar 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Jun 2016
    First version publication date
    04 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R092670PSY3011
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01515423
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan, United States, NJ 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to demonstrate in subjects stabilized on paliperidone palmitate 1 month formulation (PP1M), that paliperidone palmitate 3 month formulation (PP3M) was not less effective than PP1M in the treatment of symptoms of schizophrenia, based on the Kaplan-Meier 48-week cumulative estimate of survival (For example: percentage of subjects remaining relapse free).
    Protection of trial subjects
    The trial was performed in accordance with the principles of good clinical practices [GCP] as outlined in 21 code of federal regulations [CFR] Parts 50, 56, and 312 and the Declaration of Helsinki and its subsequent revisions, and the European Union Clinical Trials Directive that are consistent with Good Clinical Practices and applicable regulatory requirements. During the study, various safety evaluations were performed at different timepoints like clinical laboratory assessments (hematology, serum chemistry, metabolic chemistry and urinalysis), vital signs, 12-lead electrocardiograms (ECGs) and physical examination, all adverse events were reported from signing the informed consent until the follow-up visit.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 23
    Country: Number of subjects enrolled
    Spain: 42
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Taiwan: 20
    Country: Number of subjects enrolled
    Ukraine: 72
    Country: Number of subjects enrolled
    United States: 167
    Country: Number of subjects enrolled
    Argentina: 37
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Belgium: 23
    Country: Number of subjects enrolled
    Brazil: 31
    Country: Number of subjects enrolled
    Bulgaria: 38
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    China: 296
    Country: Number of subjects enrolled
    Czech Republic: 69
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 19
    Country: Number of subjects enrolled
    Greece: 14
    Country: Number of subjects enrolled
    Hungary: 51
    Country: Number of subjects enrolled
    Japan: 175
    Country: Number of subjects enrolled
    Korea, Republic of: 19
    Country: Number of subjects enrolled
    Mexico: 19
    Country: Number of subjects enrolled
    Poland: 56
    Country: Number of subjects enrolled
    Portugal: 30
    Country: Number of subjects enrolled
    Romania: 20
    Country: Number of subjects enrolled
    Russian Federation: 177
    Worldwide total number of subjects
    1429
    EEA total number of subjects
    398
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1408
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

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

    Period 1
    Period 1 title
    Open-Label
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Open-Label: Paliperidone Palmitate 1 month (PP1M)
    Arm description
    Subjects 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) subjects received the same dose of PP1M that was administered at Week 9.
    Arm type
    Experimental

    Investigational medicinal product name
    Paliperidone Palmitate
    Investigational medicinal product code
    R092670
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Paliperidone Palmitate 1 month formulation (PP1M) administered via intramuscular route in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8. At Week 5 (Day 36) and Week 9 (Day 64) given in flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) subjects received the same dose of PP1M that was administered at Week 9.

    Number of subjects in period 1
    Open-Label: Paliperidone Palmitate 1 month (PP1M)
    Started
    1429
    Completed
    1016
    Not completed
    413
         Failed to meet randomization criteria
    70
         Lack of efficacy
    117
         Adverse event, serious fatal
    2
         Adverse event, non-fatal
    40
         Consent withdrawn by subject
    118
         Unspecified
    28
         Adverse event, serious non-fatal
    17
         Lost to follow-up
    21
    Period 2
    Period 2 title
    Double-Blind
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation
    Arm description
    Subjects received Paliperidone Palmitate 3month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is subjects 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. Also the subjects received placebo injection (intralipid) at weeks 21, 25, 33 during the gap period, when they were not receiving PP3M to maintain the blind.
    Arm type
    Experimental

    Investigational medicinal product name
    Paliperidone Palmitate
    Investigational medicinal product code
    R092670
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Paliperidone Palmitate 3 month formulation (PP3M) administered via intramuscular route in a fixed dose fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received placebo injection (intralipid) at weeks 21, 25, 33 during the gap period, when they were not receiving PP3M to maintain the blind.

    Arm title
    Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Arm description
    Subjects 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, subjects received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
    Arm type
    Experimental

    Investigational medicinal product name
    Paliperidone Palmitate
    Investigational medicinal product code
    R092670
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Paliperidone Palmitate 1 month formulation (PP1M) administered via intramuscular route in a fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.).

    Number of subjects in period 2
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Started
    504
    512
    Completed
    422
    420
    Not completed
    82
    92
         Blind broken by investigator
    1
    -
         Pregnancy
    2
    -
         Adverse event, serious fatal
    1
    2
         Adverse event, non-fatal
    14
    10
         Consent withdrawn by subject
    50
    53
         Unspecified
    6
    12
         Adverse event, serious non-fatal
    1
    3
         Lost to follow-up
    7
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-Label: Paliperidone Palmitate 1 month (PP1M)
    Reporting group description
    Subjects 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) subjects received the same dose of PP1M that was administered at Week 9.

    Reporting group values
    Open-Label: Paliperidone Palmitate 1 month (PP1M) Total
    Number of subjects
    1429 1429
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    1408 1408
        From 65 to 84 years
    21 21
        85 years and over
    0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    38.4 ± 11.86 -
    Title for Gender
    Units: subjects
        Female
    647 647
        Male
    782 782

    End points

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    End points reporting groups
    Reporting group title
    Open-Label: Paliperidone Palmitate 1 month (PP1M)
    Reporting group description
    Subjects 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) subjects received the same dose of PP1M that was administered at Week 9.
    Reporting group title
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation
    Reporting group description
    Subjects received Paliperidone Palmitate 3month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is subjects 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. Also the subjects received placebo injection (intralipid) at weeks 21, 25, 33 during the gap period, when they were not receiving PP3M to maintain the blind.

    Reporting group title
    Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Reporting group description
    Subjects 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, subjects received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.

    Primary: Percentage Of Subjects Without Relapse At Week 48 During The Double-Blind

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    End point title
    Percentage Of Subjects Without Relapse At Week 48 During The Double-Blind
    End point description
    Relapse: Psychiatric hospitalization;subjects had an increase of 25 percent in total Positive and Negative Syndrome Scale (PANSS) score from randomization for 2 consecutive assessments separated by 37 days if score at randomization was greater than (>) 40; had 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 37 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 37 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 37 days in any above items if maximum score for these above PANSS items was 4 at randomization.
    End point type
    Primary
    End point timeframe
    Up to 48 weeks
    End point values
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Number of subjects analysed
    458
    490
    Units: Percentage of Subjects
        number (not applicable)
    91.2
    90
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The Kaplan-Meier method was used to estimate the 48-week cumulative estimate of survival (relapse-free). Non-inferiority of PP3M to PP1M was to be concluded if the lower limit of the 2-sided 95% confidence interval of the difference in relapse-free rates between PP3M and PP1M exceeded the pre-specified margin of -15%.
    Comparison groups
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation v Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Number of subjects included in analysis
    948
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Difference (PP3M-PP1M)
    Point estimate
    1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    5.1

    Secondary: Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48

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    End point title
    Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
    End point 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). The mITT analysis set included all subjects 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 subjects analysed is the total subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    DB Baseline (Week 17) and 48 week or DB Endpoint
    End point values
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Number of subjects analysed
    481
    503
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    57.4 ± 8.56
    58.1 ± 8.88
        Change from Baseline at DB End point
    -3.5 ± 12.5
    -4.3 ± 11.78
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Analysis of covariance (ANCOVA) model with treatment (PP1M, PP3M) and country as factors, and baseline value as a covariate was used. Difference in least squares (LS) means with corresponding 95% CI reported.
    Comparison groups
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation v Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Number of subjects included in analysis
    984
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Difference of Least Square Means
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.61
         upper limit
    2.34

    Secondary: Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48

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    End point title
    Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48
    End point description
    The Clinical Global Impression Severity (CGIS) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. 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 subjects". Higher scores indicate worsening. mITT analysis set included all subjects 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 subjects analysed is the total subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    DB Baseline (Week 17) and 48 week or DB Endpoint
    End point values
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Number of subjects analysed
    481
    504
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    2.9 ± 0.57
    2.9 ± 0.66
        Change from Baseline at DB End point
    -0.1 ± 0.84
    -0.1 ± 0.75
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Analysis of covariance (ANCOVA) model with treatment (PP1M, PP3M) and country as factors, and baseline value as a covariate was used. Difference in least squares (LS) means with corresponding 95% CI reported.
    Comparison groups
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation v Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Number of subjects included in analysis
    985
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Difference of Least Square Means
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.05
         upper limit
    0.13

    Secondary: Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48

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    End point title
    Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48
    End point description
    The Personal and Social Performance (PSP) scale assesses degree of a subject’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, selfcare, and disturbing and aggressive behavior. Score ranges from 1 to 100. Subjects 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. mITT analysis set included all subjects 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 subjects analysed is the total subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    DB Baseline (Week 17) and 48 week or DB Endpoint
    End point values
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Number of subjects analysed
    474
    495
    Units: Units of a scale
    arithmetic mean (standard deviation)
        Baseline
    65.5 ± 10.4
    65 ± 11.06
        Change from Baseline at DB End point
    1.3 ± 10.22
    1.9 ± 9.21
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Analysis of covariance (ANCOVA) model with treatment (PP1M, PP3M) and country as factors, and baseline value as a covariate was used. Difference in least squares (LS) means with corresponding 95% CI reported.
    Comparison groups
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation v Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Number of subjects included in analysis
    969
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Difference of Least Square Means
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.73
         upper limit
    0.64

    Secondary: Percentage Of Subjects Who Met The Criteria for Symptomatic Remission based on Andreasen criteria

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    End point title
    Percentage Of Subjects Who Met The Criteria for Symptomatic Remission based on Andreasen criteria
    End point 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. mITT analysis set included all subjects 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 subjects analysed is the total subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Weeks 41 to 65
    End point values
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Number of subjects analysed
    483
    512
    Units: Percentage of Subjects
        number (not applicable)
    58.4
    59.2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Positive and Negative Syndrome Subscales and Marder Factor Subscale Score at Week 48

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    End point title
    Change From Baseline in Positive and Negative Syndrome Subscales and Marder Factor Subscale Score at Week 48
    End point 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). 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.
    End point type
    Secondary
    End point timeframe
    DB Baseline (Week 17) and 48 week or DB Endpoint
    End point values
    Double-Blind:Paliperidone Palmitate 3 month (PP3M) Formulation Double-Blind:Paliperidone Palmitate 1 month (PP1M) Formulation
    Number of subjects analysed
    483
    512
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Positive subscale: Baseline
    11.9 ± 3.12
    12 ± 3.19
        Positive subscale: Change at Endpoint
    -0.6 ± 4.31
    -0.9 ± 3.7
        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 ± 6.57
        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 ± 3.9
        Negative symptoms factor: Change at Endpoint
    -1.4 ± 3.57
    -1.3 ± 3.8
        Disorganized thoughts factor: Baseline
    14.2 ± 3.2
    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 ± 2.69
    -0.2 ± 2.43
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of informed consent form up to Follow-Up Visit (4 or 12 Weeks after study drug administration)
    Adverse event reporting additional description
    For Double-blind (DB) phase, safety analysis set included all subjects who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study drug. For Open-label Phase, all subjects who received at least 1 dose of open-label study drug and were included in summary of safety assessments for that phase.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Open-Label: Paliperidone Palmitate 1 month (PP1M)
    Reporting group description
    Subjects 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) subjects received the same dose of PP1M that was administered at Week 9.

    Reporting group title
    Double-Blind: Paliperidone Palmitate 1 month (PP1M)
    Reporting group description
    Subjects 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, subjects received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.

    Reporting group title
    Double-Blind:Paliperidone Palmitate 3 month (PP3M)Formulation
    Reporting group description
    Subjects received Paliperidone Palmitate 3month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is subjects 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.

    Serious adverse events
    Open-Label: Paliperidone Palmitate 1 month (PP1M) Double-Blind: Paliperidone Palmitate 1 month (PP1M) Double-Blind:Paliperidone Palmitate 3 month (PP3M)Formulation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    101 / 1429 (7.07%)
    37 / 512 (7.23%)
    26 / 504 (5.16%)
         number of deaths (all causes)
    4
    3
    1
         number of deaths resulting from adverse events
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Artery Thrombosis
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular Carcinoma
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Neoplasm Prostate
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug Ineffective
         subjects affected / exposed
    2 / 1429 (0.14%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug Withdrawal Syndrome
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute Psychosis
         subjects affected / exposed
    2 / 1429 (0.14%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adjustment Disorder
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 1429 (0.07%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcohol Abuse
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    4 / 1429 (0.28%)
    2 / 512 (0.39%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety Disorder
         subjects affected / exposed
    2 / 1429 (0.14%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delusion
         subjects affected / exposed
    4 / 1429 (0.28%)
    2 / 512 (0.39%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depressed Mood
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 1429 (0.14%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 1429 (0.07%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination, Auditory
         subjects affected / exposed
    6 / 1429 (0.42%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hostility
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypomania
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    2 / 1429 (0.14%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Irritability
         subjects affected / exposed
    3 / 1429 (0.21%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurosis
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Persecutory Delusion
         subjects affected / exposed
    1 / 1429 (0.07%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric Symptom
         subjects affected / exposed
    4 / 1429 (0.28%)
    2 / 512 (0.39%)
    2 / 504 (0.40%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    14 / 1429 (0.98%)
    2 / 512 (0.39%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    10 / 15
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Restlessness
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    31 / 1429 (2.17%)
    11 / 512 (2.15%)
    12 / 504 (2.38%)
         occurrences causally related to treatment / all
    17 / 31
    2 / 11
    2 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia, Paranoid Type
         subjects affected / exposed
    0 / 1429 (0.00%)
    2 / 512 (0.39%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Self Injurious Behaviour
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Substance-Induced Psychotic Disorder
         subjects affected / exposed
    2 / 1429 (0.14%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    6 / 1429 (0.42%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    3 / 1429 (0.21%)
    4 / 512 (0.78%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Tension
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menstrual Disorder
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol Poisoning
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    2 / 1429 (0.14%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to Various Agents
         subjects affected / exposed
    1 / 1429 (0.07%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiac disorders
    Cardiac Arrest
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    4 / 1429 (0.28%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stupor
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal Disorder
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 1429 (0.14%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus Ureteric
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle Rigidity
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 1429 (0.00%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    1 / 504 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Ketoacidosis
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis Bacterial
         subjects affected / exposed
    0 / 1429 (0.00%)
    1 / 512 (0.20%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    1 / 1429 (0.07%)
    0 / 512 (0.00%)
    0 / 504 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Open-Label: Paliperidone Palmitate 1 month (PP1M) Double-Blind: Paliperidone Palmitate 1 month (PP1M) Double-Blind:Paliperidone Palmitate 3 month (PP3M)Formulation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    457 / 1429 (31.98%)
    208 / 512 (40.63%)
    212 / 504 (42.06%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    11 / 1429 (0.77%)
    7 / 512 (1.37%)
    12 / 504 (2.38%)
         occurrences all number
    16
    7
    13
    Investigations
    Weight Increased
         subjects affected / exposed
    64 / 1429 (4.48%)
    109 / 512 (21.29%)
    105 / 504 (20.83%)
         occurrences all number
    64
    113
    108
    Weight Decreased
         subjects affected / exposed
    10 / 1429 (0.70%)
    14 / 512 (2.73%)
    14 / 504 (2.78%)
         occurrences all number
    10
    15
    15
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    78 / 1429 (5.46%)
    14 / 512 (2.73%)
    20 / 504 (3.97%)
         occurrences all number
    82
    18
    29
    Headache
         subjects affected / exposed
    46 / 1429 (3.22%)
    26 / 512 (5.08%)
    18 / 504 (3.57%)
         occurrences all number
    52
    30
    20
    General disorders and administration site conditions
    Injection Site Pain
         subjects affected / exposed
    127 / 1429 (8.89%)
    14 / 512 (2.73%)
    12 / 504 (2.38%)
         occurrences all number
    178
    31
    21
    Injection Site Induration
         subjects affected / exposed
    40 / 1429 (2.80%)
    6 / 512 (1.17%)
    14 / 504 (2.78%)
         occurrences all number
    52
    6
    20
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    79 / 1429 (5.53%)
    22 / 512 (4.30%)
    27 / 504 (5.36%)
         occurrences all number
    87
    58
    32
    Insomnia
         subjects affected / exposed
    94 / 1429 (6.58%)
    24 / 512 (4.69%)
    16 / 504 (3.17%)
         occurrences all number
    109
    38
    16
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    66 / 1429 (4.62%)
    33 / 512 (6.45%)
    36 / 504 (7.14%)
         occurrences all number
    75
    60
    45

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jul 2013
    The amendment included that additional subjects were added to the planned number of subjects in the Open-label Phase to ensure that there were sufficient number of subjects in the per-protocol analysis set(approximately 380 per arm) and the study was statistically powered as originally planned, after a product manufacturing quality issue due to short syringe plungers was identified with one lot of study drug supply that resulted in some subjects (between 16 and 30 subjects) receiving approximately 75% of the intended dose during the Double-blind Phase; and other minor clarifications were included.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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