Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-017271-17
    Trial protocol
    		 BG  
    Global end of trial date
    22 Oct 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 May 2016
    First version publication date
    25 Jun 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    R092670-SCA-3004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01193153
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Scientific Affairs, LLC
    Sponsor organisation address
    1125 Trenton-Harbourton Road, Titusville, United States,
    Public contact
    Dong-Jing Fu, M.D., PhD, Ortho-McNeil Janssen Scientific Affairs, LLC, +1 609-730-4312, dfu@its.jnj.com
    Scientific contact
    Dong-Jing Fu, M.D., PhD, Ortho-McNeil Janssen Scientific Affairs, LLC, +1 609-730-4312, dfu@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
    22 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder and to assess the safety and tolerability of paliperidone palmitate in subjects with schizoaffective disorder.
    Protection of trial subjects
    Safety evaluations for this study included the monitoring of adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements (temperature, pulse, and blood pressure), weight, and the monitoring of extrapyramidal symptoms using the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A). Suicidality was assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). The protocol included strict requirements to ensure adequate protection of subjects participating in the study. Subjects were carefully screened using medical and psychiatric examinations and those with unstable medical conditions or suicidal behavior were excluded. In the double-blind Relapse Prevention Period, subjects who were clinically stable, exposed to double-blind medication, including placebo. The exposure of these subjects with schizoaffective disorder to placebo over an extended period under the well-controlled conditions of a clinical study was unlikely to result in any permanent damage or disability.
    Background therapy
    		 The protocol allowed subject to continue their stable doses of antidepressants and mood stabilizers. Approximately half of subjects in the study were on adjunctive antidepressants or mood stabilizers.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Sep 2010
    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
    Bulgaria: 39
    Country: Number of subjects enrolled
    India: 68
    Country: Number of subjects enrolled
    Malaysia: 17
    Country: Number of subjects enrolled
    Philippines: 17
    Country: Number of subjects enrolled
    Romania: 85
    Country: Number of subjects enrolled
    Ukraine: 116
    Country: Number of subjects enrolled
    United States: 316
    Country: Number of subjects enrolled
    South Africa: 9
    Worldwide total number of subjects
    667
    EEA total number of subjects
    124
    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)
    665
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects without previous exposure to paliperidone extended-release (ER) (Invega), or risperidone, received paliperidone ER 6 milligram per day (mg/day) for 4 to 6 days (during Screening) to test oral tolerability. Subjects, who had ability to tolerate the drug, as judged by treating physician, were eligible for enrollment in the study.

    Period 1
    Period 1 title
    Open Label
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Paliperidone Palmitate
    Arm description
    		 Open Label (OL) Lead-In (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. OL Stabilization (12 weeks): Same dose as Day 92 for Day 120 and 148. Double Blind (15 months): Same dose as Day 92 every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paliperidone Palmitate
    Investigational medicinal product code
    F013
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    OL (Open Label) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered OL stabilization period (12 weeks).

    Number of subjects in period 1
    		Paliperidone Palmitate
    Started
    667
    Completed
    334
    Not completed
    333
         Sub failed crit ent stab prd
    47
         Consent withdrawn by subject
    98
         > 6 weeks between 2 study drug
    4
         Death
    3
         Other
    22
         Pregnancy
    1
         Adverse event
    50
         Lost to follow-up
    42
         Sub failed crt db rel prv prd
    35
         Lack of efficacy
    31
    Period 2
    Period 2 title
    Double Blind Relapse Prevention Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Paliperidone Palmitate
    Arm description
    		 In Double Blind Relapse Prevention Period, on Day 176, subjects were randomized in a 1:1 ratio to receive either a fixed dose (fixed on day 92) injection every 4 weeks of paliperidone palmitate or matching placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paliperidone palmitate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Same dose as Day 92 once every 4 weeks until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.

    Arm title
    		 Placebo
    Arm description
    		 Subjects did not receive placebo during OL lead in period and OL stabilization period. Subjects received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks during double-blind relapse prevention period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks during double-blind relapse prevention period.

    Number of subjects in period 2
    		Paliperidone Palmitate Placebo
    Started
    164
    170
    Completed
    100
    65
    Not completed
    64
    105
         Consent withdrawn by subject
    19
    30
         Experienced relapse
    25
    57
         > 6 weeks between 2 study drug
    1
    3
         Death
    2
    -
         Other
    2
    3
         Pregnancy
    1
    -
         Adverse event
    12
    3
         Lost to follow-up
    2
    9

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Paliperidone Palmitate
    Reporting group description
    		 Open Label (OL) Lead-In (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. OL Stabilization (12 weeks): Same dose as Day 92 for Day 120 and 148. Double Blind (15 months): Same dose as Day 92 every 4 weeks.

    Reporting group values
    		 Paliperidone Palmitate Total
    Number of subjects
    		 667 667
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 665 665
        From 65 to 84 years
    		 2 2
        85 years and over
    		 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.5 ± 10.7 -
    Title for Gender
    Units: subjects
        Female
    		 310 310
        Male
    		 357 357

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Paliperidone Palmitate
    Reporting group description
    		 Open Label (OL) Lead-In (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. OL Stabilization (12 weeks): Same dose as Day 92 for Day 120 and 148. Double Blind (15 months): Same dose as Day 92 every 4 weeks.
    Reporting group title
    Paliperidone Palmitate
    Reporting group description
    		 In Double Blind Relapse Prevention Period, on Day 176, subjects were randomized in a 1:1 ratio to receive either a fixed dose (fixed on day 92) injection every 4 weeks of paliperidone palmitate or matching placebo.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects did not receive placebo during OL lead in period and OL stabilization period. Subjects received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks during double-blind relapse prevention period.

    Primary: Double-blind: Percentage of Participants Who Experienced Relapse

    		 Close Top of page
    End point title
    		 Double-blind: Percentage of Participants Who Experienced Relapse
    End point description
    Relapse was defined as occurrence of: psychiatric hospitalization/any intervention employed to prevent imminent hospitalization due to worsening symptoms or need for additional antipsychotic, antidepressants; deliberate self-injury, suicidal ideation that is clinically significant) determined by investigator, or violent behavior resulting in clinically significant injury to another person or property damage; worsening of any 1 or more of 8 selected Positive And Negative Syndrome Scale(PANSS) items to score of more than equal to (>= 6) after randomization (if the score for the corresponding item was <=4 at randomization); worsening of other measures at 2 consecutive visits. Relapse by subgroup of subjects on monotherapy, adjunctive therapy to antidepressants, subjects with psychotic and mood symptoms was examined. Double blind intent-to-treat (DB-ITT) analysis set included all subjects who received at least 1 dose of DB study medication. n= subjects evaluable at specific time-point.
    End point type
    Primary
    End point timeframe
    Day 1 up to Month 15 of double blind relapse prevention period
    End point values
    		 Paliperidone Palmitate Placebo
    Number of subjects analysed
    164
    170
    Units: percentage of participants
    number (not applicable)
        All Participants (n=164, 170)
    15.2
    33.5
        Monotherapy subset (n=78, 73)
    11.5
    32.9
        Adjunct therapy subset (n=86, 97)
    18.6
    34
        Psychotic Symptoms (n=164, 170)
    12.8
    31.2
        Mood Symptoms;Any Mood Symptoms (n=164, 170)
    11
    28.2
        Mood Symptoms;Manic (n=164, 170)
    3
    9.4
        Mood Symptoms;Depressive (n=164, 170)
    4.9
    13.5
        Mood Symptoms; Mixed (n=164, 170)
    3
    5.3
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    All participants: p-value was calculated using log-rank test on time to first relapse.
    Comparison groups
    Paliperidone Palmitate v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.55
         upper limit
    		 3.99
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Monotherapy subset: Hazard ratio and corresponding p-value, and 95% Confidence Interval (CI) were calculated from Cox proportional hazard regression model.
    Comparison groups
    Paliperidone Palmitate v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    3.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.57
         upper limit
    		 7.28
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Adjunct therapy subset: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
    Comparison groups
    Paliperidone Palmitate v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 3.68
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Psychotic Symptoms: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
    Comparison groups
    Paliperidone Palmitate v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 4.67
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Mood Symptoms (Any Mood Symptoms): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
    Comparison groups
    Paliperidone Palmitate v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 5.04
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Mood Symptoms (Manic): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
    Comparison groups
    Paliperidone Palmitate v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    3.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.32
         upper limit
    		 9.89
    Statistical analysis title
    		 Statistical Analysis 7
    Statistical analysis description
    Mood Symptoms (Depressive): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
    Comparison groups
    Paliperidone Palmitate v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    3.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.39
         upper limit
    		 6.98
    Statistical analysis title
    		 Statistical Analysis 8
    Statistical analysis description
    Mood Symptoms (Mixed): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.
    Comparison groups
    Paliperidone Palmitate v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.238
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 5.78

    Secondary: Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])

    		 Close Top of page
    End point title
    		 Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])
    End point description
    The PSP scale was designed to assess the degree of dysfunction a subject exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of less than equal to (<=) 30 indicated functioning so poor that participant required intensive supervision. DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind medication. Here 'n' signifies subjects who were evaluable at each specified time point for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 64 of double blind relapse prevention period
    End point values
    		 Paliperidone Palmitate Placebo
    Number of subjects analysed
    164
    170
    Units: Units on a scale
    least squares mean (standard error)
        Baseline (n=164, 170)
    72.8 ± 0.81
    74.5 ± 0.81
        Change at Week 64 (n=98, 65)
    2 ± 0.92
    -1.3 ± 1.03
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The null hypothesis is that there is no difference in the mean of the PSP total score between the two treatment groups.
    Comparison groups
    Paliperidone Palmitate v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.014
    Method
    		 MMRM ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 5.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.33

    Secondary: Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint

    		 Close Top of page
    End point title
    		 Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint
    End point description
    The PSP scale was designed to assess the degree of dysfunction a subject exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 = good functioning; 31 and 70 = varying degrees of difficulty, and a score of less than equal to (<=) 30 indicated functioning so poor that participant required intensive supervision. OL ITT analysis set which included all subjects who received at least one injection of open-label study medication. Last Observation Carried Forward (LOCF) method was used to impute missing values. Here 'n' signifies participants who were evaluable at each specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
    End point values
    		 Paliperidone Palmitate
    Number of subjects analysed
    667
    Units: Units on a Scale
    arithmetic mean (standard deviation)
        OL Lead-in Period:Baseline (n=667)
    51.4 ± 11.02
        OL Lead-in Period:Change at Endpoint (n=622)
    12.6 ± 13.71
        OL Stabilization Period:Change at Endpoint (n=622)
    13.8 ± 14.92
    No statistical analyses for this end point

    Secondary: Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint

    		 Close Top of page
    End point title
    		 Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint
    End point description
    The PSP scale was designed to assess the degree of dysfunction a subject exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision. DB ITT analysis set which included all randomly assigned participants w ho received at least one injection of double-blind study medication. LOCF method was used to impute missing values. Here 'n' signifies subjects who were evaluable at each specified time point for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 64/LOCF) in double-blind period
    End point values
    		 Paliperidone Palmitate Placebo
    Number of subjects analysed
    164
    170
    Units: Units on a Scale
    least squares mean (standard error)
        Double-blind: Baseline (n=164, 170)
    74.5 ± 0.81
    72.8 ± 0.81
        Double-blind: Change at Endpoint (n=161,168)
    0.5 ± 1.15
    -4.1 ± 1.13
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Paliperidone Palmitate v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.94
         upper limit
    		 7.15

    Secondary: Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores

    		 Close Top of page
    End point title
    		 Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores
    End point description
    The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. Number of participants in each specific category; good functioning (PSP total score >70), variable functioning (PSP total score between 31 and 70), and poor functioning (PSP total score <=30) were assessed. DB ITT analysis set which included all randomly assigned participants w ho received at least one injection of double-blind study medication. LOCF method was used to impute missing values. Here 'n' signifies subjects who were evaluable at each specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 64/LOCF) in DB period
    End point values
    		 Paliperidone Palmitate Placebo
    Number of subjects analysed
    164
    170
    Units: participants
        Baseline: Poor (n=164, 170)
    0
    0
        Baseline: Variable (n=164, 170)
    69
    84
        Baseline: Good (n=164, 170)
    95
    86
        Endpoint: Poor (n=161, 168)
    1
    4
        Endpoint: Variable (n=161, 168)
    65
    95
        Endpoint: Good (n=161, 168)
    95
    69
    No statistical analyses for this end point

    Secondary: Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint

    		 Close Top of page
    End point title
    		 Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint
    End point description
    The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Open Label (OL) Intent-to-treat (ITT) analysis set which included all subjects who received at least one injection of open-label study medication. LOCF method was used to impute missing values. Here 'n' signifies subjects who were evaluable at each specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
    End point values
    		 Paliperidone Palmitate
    Number of subjects analysed
    667
    Units: Units on a scale
    arithmetic mean (standard deviation)
        OL Lead-in Period:Baseline (n=667)
    85.8 ± 12.76
        OL Lead-in Period:Change at Endpoint (n=653)
    -21.8 ± 16.39
        OL Stabilization Period:Change at Endpoint (n=653)
    -23.8 ± 18.3
    No statistical analyses for this end point

    Secondary: Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint

    		 Close Top of page
    End point title
    		 Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint
    End point description
    The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. Here 'n' signifies subjects who were evaluable at each specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 64/LOCF) in double-blind period
    End point values
    		 Paliperidone Palmitate Placebo
    Number of subjects analysed
    164
    170
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Double-blind: Baseline (n=164, 170)
    51.1 ± 9.5
    51.8 ± 9.47
        Double-blind: Change at Endpoint (n=161, 168)
    0.5 ± 14.01
    7.4 ± 18.53
    No statistical analyses for this end point

    Secondary: Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint

    		 Close Top of page
    End point title
    		 Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
    End point description
    The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63. OL ITT analysis set which included all subjects who received at least one injection of open-label study medication. LOCF method was used to impute missing values. Here 'n' signifies subjects who were evaluable at each specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
    End point values
    		 Paliperidone Palmitate
    Number of subjects analysed
    667
    Units: Units on a scale
    arithmetic mean (standard deviation)
        OL Lead-in Period:Baseline (n=667)
    20.4 ± 7.81
        OL Lead-in Period:Change at Endpoint (n=653)
    -9.7 ± 8.53
        OL Stabilization Period:Change at Endpoint (n=653)
    -9.9 ± 9.08
    No statistical analyses for this end point

    Secondary: Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint

    		 Close Top of page
    End point title
    		 Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
    End point description
    The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63. DB ITT analysis set which included all randomly assigned subjects w ho received at least one injection of double-blind study medication. LOCF method was used to impute missing values. Here 'n' signifies subjects who were evaluable at each specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 64/LOCF) in double-blind period
    End point values
    		 Paliperidone Palmitate Placebo
    Number of subjects analysed
    164
    170
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Double-blind: Baseline (n=164, 170)
    5.7 ± 3.24
    5.6 ± 3.32
        Double-blind: Change at Endpoint (n=161, 168)
    0.8 ± 5.4
    3.4 ± 7.42
    No statistical analyses for this end point

    Secondary: Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint

    		 Close Top of page
    End point title
    		 Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint
    End point description
    The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment, and to detect a return of manic symptoms. YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8(that is, 0, 2, 4, 6, 8). The item score is based on participant's report and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60. OL ITT analysis set which included all subjects who received at least 1 injection of OL study medication. Here 'n' signifies participants who were evaluable at each point.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
    End point values
    		 Paliperidone Palmitate
    Number of subjects analysed
    667
    Units: Units on a scale
    arithmetic mean (standard deviation)
        OL Lead-in Period:Baseline (n=667)
    18.6 ± 9.48
        OL Lead-in Period:Change at Endpoint (n=653)
    -9.9 ± 9.45
        OL Stabilization Period:Change at Endpoint (n=653
    -10.5 ± 10.14
    No statistical analyses for this end point

    Secondary: Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint

    		 Close Top of page
    End point title
    		 Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint
    End point description
    The YMRS was designed to measure the severity of manic symptoms, the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4/0 to 8. Seven items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 (that is, 0, 2, 4, 6, 8). The item score is based on subject's report of his or her condition and clinician's behavioral observations during the interview. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60. DB ITT analysis set which included all randomly assigned participants who received at least 1 injection of OL study medication. Here 'n' signifies subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 64/LOCF) in double-blind period
    End point values
    		 Paliperidone Palmitate Placebo
    Number of subjects analysed
    164
    170
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Double-blind: Baseline (n=164, 170)
    4.4 ± 3.46
    4.4 ± 3.4
        Double-blind: Change at Endpoint (n=161,168)
    -0.1 ± 5.47
    3.2 ± 7.21
    No statistical analyses for this end point

    Secondary: Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint

    		 Close Top of page
    End point title
    		 Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint
    End point description
    The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit". OL ITT analysis set which included all subjects who received at least one injection of open-label study medication. LOCF method was used to impute missing values. Here 'n' signifies subjects who were evaluable at each specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period
    End point values
    		 Paliperidone Palmitate
    Number of subjects analysed
    667
    Units: Units on a scale
    arithmetic mean (standard deviation)
        OL Lead-in Period:Baseline (n=667)
    4.4 ± 0.58
        OL Lead-in Period:Change at Endpoint (n=652)
    -1.3 ± 0.99
        OL Stabilization Period:Change at Endpoint (n=652)
    -1.3 ± 1.07
    No statistical analyses for this end point

    Secondary: Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint

    		 Close Top of page
    End point title
    		 Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint
    End point description
    The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit". DB ITT analysis set which included all randomly assigned subjects who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. Here 'n' signifies subjects who were evaluable at each specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Endpoint (Week 64/LOCF) in double-blind period
    End point values
    		 Paliperidone Palmitate Placebo
    Number of subjects analysed
    164
    170
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Double-blind: Baseline (n=164, 170)
    2.4 ± 0.68
    2.5 ± 0.69
        Double-blind: Change at Endpoint (n=161,168)
    0 ± 1.02
    0.4 ± 1.15
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Day 176
    Adverse event reporting additional description
    Adverse events were recorded for all participants according to each period. Number of participants analyzed were all participants in Open Label period who received paliperidone palmitate, participants in double Blind - paliperidone palmitate and participants in double Blind period who received Placebo.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Open Label - Paliperidone Palmitate
    Reporting group description
    		 -

    Reporting group title
    Double Blind - Placebo
    Reporting group description
    		 -

    Reporting group title
    Double Blind - Paliperidone Palmitate
    Reporting group description
    		 -

    Serious adverse events
    		 Open Label - Paliperidone Palmitate Double Blind - Placebo Double Blind - Paliperidone Palmitate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    54 / 667 (8.10%)
    16 / 170 (9.41%)
    9 / 164 (5.49%)
         number of deaths (all causes)
    4
    1
    2
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Brain Contusion
         subjects affected / exposed
    0 / 667 (0.00%)
    1 / 170 (0.59%)
    0 / 164 (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
    Multiple Injuries
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Overdose
         subjects affected / exposed
    0 / 667 (0.00%)
    0 / 170 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Road Traffic Accident
         subjects affected / exposed
    0 / 667 (0.00%)
    1 / 170 (0.59%)
    0 / 164 (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
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    2 / 667 (0.30%)
    0 / 170 (0.00%)
    0 / 164 (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
    Cardiac disorders
    Atrioventricular Block Complete
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 667 (0.00%)
    0 / 170 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic Shock
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Congestive Cardiomyopathy
         subjects affected / exposed
    0 / 667 (0.00%)
    0 / 170 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    0 / 667 (0.00%)
    0 / 170 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Myocardial Infarction
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Surgical and medical procedures
    Therapy Regimen Changed
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Nervous system disorders
    Coma
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Viith Nerve Paralysis
         subjects affected / exposed
    0 / 667 (0.00%)
    1 / 170 (0.59%)
    0 / 164 (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
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 667 (0.00%)
    0 / 170 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Ear and labyrinth disorders
    Meniere's Disease
         subjects affected / exposed
    0 / 667 (0.00%)
    1 / 170 (0.59%)
    0 / 164 (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
    Colitis
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 667 (0.00%)
    0 / 170 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Completed Suicide
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Confusional State
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Delusion
         subjects affected / exposed
    0 / 667 (0.00%)
    1 / 170 (0.59%)
    0 / 164 (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
    Depression
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    2 / 164 (1.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression Suicidal
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Depressive Symptom
         subjects affected / exposed
    2 / 667 (0.30%)
    0 / 170 (0.00%)
    0 / 164 (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
    Hallucination, Auditory
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Homicidal Ideation
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Mania
         subjects affected / exposed
    3 / 667 (0.45%)
    1 / 170 (0.59%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paranoia
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Psychotic Disorder
         subjects affected / exposed
    4 / 667 (0.60%)
    2 / 170 (1.18%)
    2 / 164 (1.22%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Restlessness
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Schizoaffective Disorder
         subjects affected / exposed
    16 / 667 (2.40%)
    7 / 170 (4.12%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    2 / 17
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    15 / 667 (2.25%)
    2 / 170 (1.18%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    1 / 16
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    2 / 667 (0.30%)
    0 / 170 (0.00%)
    0 / 164 (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
    Bladder Prolapse
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Bronchitis
         subjects affected / exposed
    0 / 667 (0.00%)
    0 / 170 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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
    Lobar Pneumonia
         subjects affected / exposed
    1 / 667 (0.15%)
    0 / 170 (0.00%)
    0 / 164 (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 Double Blind - Placebo Double Blind - Paliperidone Palmitate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    332 / 667 (49.78%)
    62 / 170 (36.47%)
    79 / 164 (48.17%)
    Investigations
    Glycosylated Haemoglobin Increased
         subjects affected / exposed
    1 / 667 (0.15%)
    4 / 170 (2.35%)
    2 / 164 (1.22%)
         occurrences all number
    1
    4
    2
    Blood Prolactin Increased
         subjects affected / exposed
    4 / 667 (0.60%)
    2 / 170 (1.18%)
    4 / 164 (2.44%)
         occurrences all number
    4
    2
    4
    Weight Decreased
         subjects affected / exposed
    2 / 667 (0.30%)
    2 / 170 (1.18%)
    5 / 164 (3.05%)
         occurrences all number
    2
    2
    5
    Weight Increased
         subjects affected / exposed
    57 / 667 (8.55%)
    8 / 170 (4.71%)
    14 / 164 (8.54%)
         occurrences all number
    58
    9
    14
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    74 / 667 (11.09%)
    3 / 170 (1.76%)
    5 / 164 (3.05%)
         occurrences all number
    85
    3
    5
    Dyskinesia
         subjects affected / exposed
    14 / 667 (2.10%)
    3 / 170 (1.76%)
    1 / 164 (0.61%)
         occurrences all number
    14
    4
    1
    Headache
         subjects affected / exposed
    36 / 667 (5.40%)
    6 / 170 (3.53%)
    9 / 164 (5.49%)
         occurrences all number
    48
    6
    16
    Parkinsonism
         subjects affected / exposed
    43 / 667 (6.45%)
    3 / 170 (1.76%)
    3 / 164 (1.83%)
         occurrences all number
    47
    4
    3
    Somnolence
         subjects affected / exposed
    21 / 667 (3.15%)
    2 / 170 (1.18%)
    2 / 164 (1.22%)
         occurrences all number
    26
    2
    2
    Tremor
         subjects affected / exposed
    23 / 667 (3.45%)
    4 / 170 (2.35%)
    2 / 164 (1.22%)
         occurrences all number
    24
    5
    2
    General disorders and administration site conditions
    Injection Site Pain
         subjects affected / exposed
    71 / 667 (10.64%)
    2 / 170 (1.18%)
    1 / 164 (0.61%)
         occurrences all number
    109
    3
    1
    Fatigue
         subjects affected / exposed
    20 / 667 (3.00%)
    0 / 170 (0.00%)
    3 / 164 (1.83%)
         occurrences all number
    20
    0
    5
    Pyrexia
         subjects affected / exposed
    8 / 667 (1.20%)
    2 / 170 (1.18%)
    6 / 164 (3.66%)
         occurrences all number
    8
    2
    6
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    14 / 667 (2.10%)
    0 / 170 (0.00%)
    2 / 164 (1.22%)
         occurrences all number
    16
    0
    3
    Diarrhoea
         subjects affected / exposed
    20 / 667 (3.00%)
    2 / 170 (1.18%)
    4 / 164 (2.44%)
         occurrences all number
    23
    2
    8
    Dry Mouth
         subjects affected / exposed
    15 / 667 (2.25%)
    1 / 170 (0.59%)
    0 / 164 (0.00%)
         occurrences all number
    15
    1
    0
    Nausea
         subjects affected / exposed
    17 / 667 (2.55%)
    3 / 170 (1.76%)
    2 / 164 (1.22%)
         occurrences all number
    18
    3
    2
    Toothache
         subjects affected / exposed
    8 / 667 (1.20%)
    2 / 170 (1.18%)
    5 / 164 (3.05%)
         occurrences all number
    8
    2
    6
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    18 / 667 (2.70%)
    2 / 170 (1.18%)
    3 / 164 (1.83%)
         occurrences all number
    18
    2
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 667 (1.50%)
    2 / 170 (1.18%)
    5 / 164 (3.05%)
         occurrences all number
    11
    4
    5
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    9 / 667 (1.35%)
    4 / 170 (2.35%)
    3 / 164 (1.83%)
         occurrences all number
    9
    4
    3
    Schizoaffective Disorder
         subjects affected / exposed
    6 / 667 (0.90%)
    3 / 170 (1.76%)
    4 / 164 (2.44%)
         occurrences all number
    8
    3
    4
    Insomnia
         subjects affected / exposed
    67 / 667 (10.04%)
    12 / 170 (7.06%)
    8 / 164 (4.88%)
         occurrences all number
    81
    13
    27
    Suicidal Ideation
         subjects affected / exposed
    16 / 667 (2.40%)
    2 / 170 (1.18%)
    5 / 164 (3.05%)
         occurrences all number
    19
    2
    5
    Endocrine disorders
    Hyperprolactinaemia
         subjects affected / exposed
    9 / 667 (1.35%)
    2 / 170 (1.18%)
    7 / 164 (4.27%)
         occurrences all number
    9
    2
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    14 / 667 (2.10%)
    3 / 170 (1.76%)
    2 / 164 (1.22%)
         occurrences all number
    16
    4
    2
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    14 / 667 (2.10%)
    4 / 170 (2.35%)
    7 / 164 (4.27%)
         occurrences all number
    14
    4
    12
    Nasopharyngitis
         subjects affected / exposed
    9 / 667 (1.35%)
    6 / 170 (3.53%)
    9 / 164 (5.49%)
         occurrences all number
    10
    8
    11
    Urinary Tract Infection
         subjects affected / exposed
    8 / 667 (1.20%)
    4 / 170 (2.35%)
    5 / 164 (3.05%)
         occurrences all number
    8
    4
    5
    Metabolism and nutrition disorders
    Increased Appetite
         subjects affected / exposed
    18 / 667 (2.70%)
    0 / 170 (0.00%)
    0 / 164 (0.00%)
         occurrences all number
    18
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jan 2011
    The original protocol (dated: 24 Nov 2009 ) was updated 4 times. Out of which the third amendment dated (04 Jan 2011) was considered substantial. The amendment stated that: Additional analysis of the long-term antidepressants effects of paliperidone palmitate should be performed at the request of the European Regulatory Authority using the Hamilton Rating Scale for Depression (HAM-D-17), which was the first 17 items in the currently collected HAM-D- 21. In addition, switch-to-depression, worsening of preexisting depression, and de novo depression were to be evaluated at the request of the European Regulatory Authority. Change in the upper limit of age for inclusion in the study has been removed to allow for evaluation of efficacy and safety in subjects older than 65 years of age made at the request of the European Regulatory Authority. Clarification of adjunctive therapy including stable dose definition and addition of definition for essentially free of mood stabilizers or antidepressants use was allowed for subjects with limited use of mood stabilizers or antidepressants within 30 days prior to screening to be enrolled in the monotherapy group. At the request of the European Regulatory Authority, additional analysis were carried out for time to early discontinuation of study medication during the double-blind period for any reason including relapse (not including termination of the study by the sponsor) and for any reason not including relapse.

    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.
    In studies for regulatory submission, subject population was chosen to minimize confounding factors. The study had a fixed duration of 15-month DB treatment. The findings may differ for other durations. There was no comparator group in OL evaluation.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 18 23:20:02 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA