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    Clinical Trial Results:
    A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3-Month Formulation for the Treatment of Subjects with Schizophrenia

    Summary
    EudraCT number
    		 2011-004676-11
    Trial protocol
    		 RO  
    Global end of trial date
    09 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2016
    First version publication date
    15 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    R092670-PSY-3012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01529515
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    Archimedsweg 29-2333CM, Leiden, Netherlands, B235-0
    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
    09 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of paliperidone palmitate 3-month formulation (PP3M) compared with placebo in delaying the time to first occurrence of relapse of the symptoms of schizophrenia.
    Protection of trial subjects
    The safety assessments included treatment emergent adverse events (TEAEs) pre- and post-baseline, laboratory results (including HOMA modeling and glucose abnormalities), vital sign measurement, weight, waist circumference, BMI, ECG data, EPS ratings and assessment scales (AIMS, BARS, SAS), use of anticholinergic medication, injection site evaluations, and the Columbia Suicide Severity Rating Scale (C-SSRS) was administered to assess suicidality. Adverse events and vital signs were monitored throughout the study.
    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?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Colombia: 41
    Country: Number of subjects enrolled
    Korea, Republic of: 10
    Country: Number of subjects enrolled
    Mexico: 28
    Country: Number of subjects enrolled
    Malaysia: 29
    Country: Number of subjects enrolled
    Romania: 42
    Country: Number of subjects enrolled
    Turkey: 17
    Country: Number of subjects enrolled
    Ukraine: 181
    Country: Number of subjects enrolled
    United States: 158
    Worldwide total number of subjects
    506
    EEA total number of subjects
    42
    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)
    504
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 509 participants were enrolled in to the study and 506 participants were entered the Open label Transition and received at least one dose of study drug (PP1M). 2 participants were enrolled but not received study drug and 1 participant was screen failure.

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

    Arms
    Arm title
    		 Open-Label Transition Phase: Paliperidone Palmitate 1-Month
    Arm description
    		 Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paliperidone Palmitate - extended release suspension for injection - 50 mg eq.
    Investigational medicinal product code
    R092670
    Other name
    Paliperidone Palmitate
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were administered Paliperidone palmitate intramuscular (IM) injection at a dose of 100 mg eq.

    Investigational medicinal product name
    Paliperidone Palmitate - extended release suspension for injection - 75 mg eq.
    Investigational medicinal product code
    R092670
    Other name
    Paliperidone Palmitate
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were administered Paliperidone Palmitate intramuscular (IM) injection at a dose of 75 mg eq.

    Investigational medicinal product name
    Paliperidone Palmitate - extended release suspension for injection - 100 mg eq.
    Investigational medicinal product code
    R092670
    Other name
    Paliperidone Palmitate
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were administered Paliperidone Palmitate intramuscular (IM) injection at a dose of 100 mg eq.

    Investigational medicinal product name
    Paliperidone Palmitate - extended release suspension for injection - 150 mg eq.
    Investigational medicinal product code
    R092670
    Other name
    Paliperidone Palmitate
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were administered Paliperidone Palmitate intramuscular (IM) injection at a dose of 150 mg eq.

    Number of subjects in period 1
    		Open-Label Transition Phase: Paliperidone Palmitate 1-Month
    Started
    506
    Completed
    379
    Not completed
    127
         Consent withdrawn by subject
    51
         Adverse event, non-fatal
    16
         Death
    1
         Failed Maintenance Phase Criteria
    8
         Unspecified
    9
         Lost to follow-up
    19
         Lack of efficacy
    19
         Protocol deviation
    4
    Period 2
    Period 2 title
    Open Label Maintenance Phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month
    Arm description
    		 Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paliperidone Palmitate - extended release suspension for injection
    Investigational medicinal product code
    R092670
    Other name
    Paliperidone Palmitate
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Paliperidone palmitate IM was administered at a dose of 3.5-fold multiple of the PP1M dose (175 mg eq. to 525 mg eq.) received on Day 92 during the Transition Phase.

    Number of subjects in period 2
    		Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month
    Started
    379
    Completed
    305
    Not completed
    74
         Consent withdrawn by subject
    15
         Failed Randomization Criteria
    13
         Adverse event, non-fatal
    10
         Unspecified
    10
         Lost to follow-up
    5
         Lack of efficacy
    9
         Protocol deviation
    12
    Period 3
    Period 3 title
    Double Blind Phase
    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 Phase: Placebo
    Arm description
    		 Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
    Arm type
    		 Experimental

    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
    Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection.

    Arm title
    		 Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Arm description
    		 Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paliperidone Palmitate - extended release suspension for injection
    Investigational medicinal product code
    R092670
    Other name
    Paliperidone Palmitate
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were administered Paliperidone Palmitate IM at a dose of 175 mg eq., 263 mg eq., 350 mg eq. or 525 mg eq. every 12 weeks.

    Number of subjects in period 3
    		Double-Blind Phase: Placebo Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Started
    145
    160
    Completed
    122
    148
    Not completed
    23
    12
         Consent withdrawn by subject
    10
    7
         Adverse event, non-fatal
    1
    -
         Pregnancy
    1
    -
         Unspecified
    9
    2
         Lost to follow-up
    1
    3
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-Label Transition Phase: Paliperidone Palmitate 1-Month
    Reporting group description
    		 Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.

    Reporting group values
    		 Open-Label Transition Phase: Paliperidone Palmitate 1-Month Total
    Number of subjects
    		 506 506
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 504 504
        From 65 to 84 years
    		 2 2
        85 years and over
    		 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.4 ± 11.15 -
    Title for Gender
    Units: subjects
        Female
    		 127 127
        Male
    		 379 379

    End points

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    End points reporting groups
    Reporting group title
    Open-Label Transition Phase: Paliperidone Palmitate 1-Month
    Reporting group description
    		 Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.
    Reporting group title
    Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month
    Reporting group description
    		 Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
    Reporting group title
    Double-Blind Phase: Placebo
    Reporting group description
    		 Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.

    Reporting group title
    Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Reporting group description
    		 Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.

    Subject analysis set title
    Intent-to-treat (ITT) double blind (DB)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during the Double-blind Phase and received at least one dose of Double-blind study agent.

    Primary: Time to Relapse During the Double-Blind Phase

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    End point title
    		 Time to Relapse During the Double-Blind Phase
    End point description
    Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method. The value '99999' indicates data for this time points is not available.
    End point type
    Primary
    End point timeframe
    Approximately Week 60
    End point values
    		 Double-Blind Phase: Placebo Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Number of subjects analysed
    145
    160
    Units: Percentage of days
        median (confidence interval 95%)
    395 (274 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    		 Statistical Analysis-I
    Comparison groups
    Double-Blind Phase: Placebo v Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    3.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.08
         upper limit
    		 6.99

    Secondary: Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase

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    End point title
    		 Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
    End point description
    The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
    End point values
    		 Double-Blind Phase: Placebo Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Number of subjects analysed
    142
    159
    Units: Units on a Scale
    arithmetic mean (standard deviation)
        Baseline
    54.3 ± 9.2
    54.8 ± 9.96
        Change at Endpoint (Approximately Week 60)
    6.7 ± 14.4
    -0.5 ± 8.36
    Statistical analysis title
    		 Statistical Analysis I
    Comparison groups
    Double-Blind Phase: Placebo v Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Difference of LS Means
    Point estimate
    -7.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.87
         upper limit
    		 -4.6

    Secondary: Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase

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    End point title
    		 Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
    End point description
    The CGI-S rating scale used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
    End point values
    		 Double-Blind Phase: Placebo Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Number of subjects analysed
    142
    159
    Units: Units on a Scale
    arithmetic mean (standard deviation)
        Baseline
    2.8 ± 0.65
    2.7 ± 0.68
        Change at Endpoint (Approximately Week 60)
    0.4 ± 0.87
    0.1 ± 0.6
    Statistical analysis title
    		 Statistical Analysis-I
    Comparison groups
    Double-Blind Phase: Placebo v Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Difference of LS Means
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.18

    Secondary: Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase

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    End point title
    		 Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
    End point description
    The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
    End point values
    		 Double-Blind Phase: Placebo Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Number of subjects analysed
    142
    157
    Units: Units on a Scale
    arithmetic mean (standard deviation)
        Baseline
    68.5 ± 8.93
    68.9 ± 9.34
        Change at Endpoint (Approximately Week 60)
    -4.2 ± 9.7
    -0.5 ± 6.63
    Statistical analysis title
    		 Statistical Analysis I
    Comparison groups
    Double-Blind Phase: Placebo v Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Difference of LS Means
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.89
         upper limit
    		 5.65

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 92
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    PP3M
    Reporting group description
    		 Paliperidone Palmitate 3-month formulation

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 PP3M Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 160 (2.50%)
    15 / 145 (10.34%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Transaminases Increased
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 160 (0.63%)
    11 / 145 (7.59%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia, Paranoid Type
         subjects affected / exposed
    1 / 160 (0.63%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    2 / 160 (1.25%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 PP3M Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 160 (44.38%)
    65 / 145 (44.83%)
    Investigations
    Blood Glucose Increased
         subjects affected / exposed
    3 / 160 (1.88%)
    3 / 145 (2.07%)
         occurrences all number
    3
    3
    Weight Decreased
         subjects affected / exposed
    2 / 160 (1.25%)
    11 / 145 (7.59%)
         occurrences all number
    2
    12
    Weight Increased
         subjects affected / exposed
    14 / 160 (8.75%)
    5 / 145 (3.45%)
         occurrences all number
    14
    5
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    7 / 160 (4.38%)
    1 / 145 (0.69%)
         occurrences all number
    7
    1
    Headache
         subjects affected / exposed
    14 / 160 (8.75%)
    6 / 145 (4.14%)
         occurrences all number
    17
    6
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    1 / 160 (0.63%)
    3 / 145 (2.07%)
         occurrences all number
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 160 (3.13%)
    3 / 145 (2.07%)
         occurrences all number
    5
    3
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    2 / 160 (1.25%)
    3 / 145 (2.07%)
         occurrences all number
    2
    3
    Anxiety
         subjects affected / exposed
    13 / 160 (8.13%)
    15 / 145 (10.34%)
         occurrences all number
    14
    19
    Insomnia
         subjects affected / exposed
    11 / 160 (6.88%)
    17 / 145 (11.72%)
         occurrences all number
    12
    17
    Schizophrenia
         subjects affected / exposed
    1 / 160 (0.63%)
    8 / 145 (5.52%)
         occurrences all number
    1
    8
    Suicidal Ideation
         subjects affected / exposed
    0 / 160 (0.00%)
    3 / 145 (2.07%)
         occurrences all number
    0
    3
    Infections and infestations
    Influenza
         subjects affected / exposed
    3 / 160 (1.88%)
    3 / 145 (2.07%)
         occurrences all number
    5
    3
    Nasopharyngitis
         subjects affected / exposed
    9 / 160 (5.63%)
    2 / 145 (1.38%)
         occurrences all number
    9
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    6 / 160 (3.75%)
    3 / 145 (2.07%)
         occurrences all number
    7
    3
    Urinary Tract Infection
         subjects affected / exposed
    5 / 160 (3.13%)
    2 / 145 (1.38%)
         occurrences all number
    5
    2
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 160 (0.63%)
    3 / 145 (2.07%)
         occurrences all number
    1
    3
    Hyperglycaemia
         subjects affected / exposed
    0 / 160 (0.00%)
    4 / 145 (2.76%)
         occurrences all number
    0
    4

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Feb 2012
    The overall reason for the amendment was to include the following changes:1) Procedures to initiate study agent administration in participants 2) Inclusion and exclusion criteria were changed 3) Patient Stated-choice Preference Survey was added.4) Instructions for collection, handling, and shipping of samples for PK analysis and for screening of prohibited antipsychotics were revised, and addition of urine drug screen test strip for investigators was included.5) Blood type Rh factor was removed from the Time and Events Schedule due to logistical difficulties .6) The Double-blind Phase eligibility criteria and number of blood samples collected per participants were corrected.7) Study Agent Administrator task clarified.
    02 Jul 2012
    The overall reason for the amendment was to include the following changes from :1) The United States (US) Food and Drug Administration (FDA) instructed to increase the number of relapse events at interim analysis and the use of error spending function based on the O’Brien Fleming method was started.2) As per IEC/IRB and/or investigators visits were added to monitor for potential impending relapses during the Double-blind Phase. 3) Changes in the exclusion criteria were made to remove that was too restrictive wording.
    13 May 2013
    The overall reason for the amendment was to include the following changes 1) A new biomarker component was incorporated to measure serum biomarkers that predict : impending symptom exacerbation,symptom stability correlations with systemic drug exposure of paliperidone during the Maintenance and Double-blind Phases.
    25 Jul 2013
    The overall reason for the amendment was to include following changes: (1) Countries that were to participate in the biomarker component of the study were specified; (2) Clarification on where urine drug screen was to be performed was provided, (3) Clarification on procedures for serum biomarker sample handling was added. Minor formatting and edits were made for consistency and clarity. At the time of this amendment, 506 subjects were enrolled in the study.

    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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