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   44335   clinical trials with a EudraCT protocol, of which   7366   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 28-week, randomised, open-label study evaluating the effectiveness of aripiprazole once-monthly versus paliperidone palmitate in adult patients with schizophrenia

    Summary
    EudraCT number
    		 2012-002785-12
    Trial protocol
    		 SE   IT   DE   ES   CZ   EE   GB  
    Global end of trial date
    29 Sep 2014

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    14724A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01795547
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, , LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, , LundbeckClinicalTrials@lundbeck.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
    29 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2013
    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
    Spain: 38
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Czech Republic: 28
    Country: Number of subjects enrolled
    Estonia: 30
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Italy: 32
    Country: Number of subjects enrolled
    United States: 100
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    France: 15
    Worldwide total number of subjects
    295
    EEA total number of subjects
    183
    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)
    295
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aripiprazol
    Arm description
    		 Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets was taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aripiprazole (tablet)
    Investigational medicinal product code
    Other name
    Abilify
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 to 30 mg/day during three week Oral Conversion. Followed by one week 10-30 mg/day. Then 400 mg injection followed by two weeks with 10-20 mg/day (5, 10, and 15 mg tablets, orally. )

    Investigational medicinal product name
    Aripiprazole (injection)
    Investigational medicinal product code
    Other name
    Abilify
    Pharmaceutical forms
    Powder and solvent for prolonged-release suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    400 and 300 mg every 4 weeks (once-monthly). Total 6 times total during week 5 to 28

    Arm title
    		 Paliperidone
    Arm description
    		 Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paliperidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 to 12 mg/day during three week Oral Conversion. (3, 6, and 9 mg tablets, orally. )

    Investigational medicinal product name
    Paliperidone (injection)
    Investigational medicinal product code
    Other name
    Xeplion®, Invega®, Sustenna®
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    150 mg and 300 mg every 4 weeks (once-monthly). Total 6 times total during week 5 to 28

    Number of subjects in period 1
    		Aripiprazol Paliperidone
    Started
    148
    147
    Treated
    144
    137
    Completed
    100
    83
    Not completed
    48
    64
         non-compliance with IMP
    1
    1
         Consent withdrawn by subject
    7
    12
         not treated
    4
    10
         Others
    4
    1
         Adverse event, non-fatal
    16
    27
         Lost to follow-up
    2
    5
         Not stated
    -
    1
         Lack of efficacy
    8
    3
         Protocol deviation
    6
    4

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Aripiprazol
    Reporting group description
    		 Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets was taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24

    Reporting group title
    Paliperidone
    Reporting group description
    		 Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI

    Reporting group values
    		 Aripiprazol Paliperidone Total
    Number of subjects
    		 148 147 295
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 148 147 295
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.6 ( 10.83 ) 41 ( 10.87 ) -
    Gender categorical
    Units: Subjects
        Female
    		 59 59 118
        Male
    		 89 88 177
    Race
    Units: Subjects
        Asian
    		 1 3 4
        White
    		 102 102 204
        American Indian or Alaska Native
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 44 38 82
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 4 5

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Aripiprazol
    Reporting group description
    		 Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets was taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24

    Reporting group title
    Paliperidone
    Reporting group description
    		 Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI

    Primary: Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score

    		 Close Top of page
    End point title
    		 Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score
    End point description
    The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.
    End point type
    Primary
    End point timeframe
    Baseline to Week 28
    End point values
    		 Aripiprazol Paliperidone
    Number of subjects analysed
    136
    132
    Units: units on a scale
        least squares mean (standard error)
    7.47 ( 1.53 )
    2.8 ( 1.62 )
    Statistical analysis title
    		 Aripiprazol vs Paliperidone
    Comparison groups
    Aripiprazol v Paliperidone
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.036
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    4.666
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.316
         upper limit
    		 9.015
    Notes
    [1] - Non-inferiority of the primary endpoint was considered confirmed if the lower bound of the 2-sided 95% CI at Week 28 was > -5 or equivalently if the p-value for the 1-sided test of H0: D ≤ -5 against H1: D > -5 was ≤2.5%, where D was the mean treatment difference (aripiprazole minus paliperidone). Superiority was then tested as pre-specified with the FAS and demonstrated for aripiprazole over paliperidone, since the lower bound of the 95% CI was >0

    Secondary: Investigator’s Assessment Questionnaire (IAQ) Total Score at Week 28

    		 Close Top of page
    End point title
    		 Investigator’s Assessment Questionnaire (IAQ) Total Score at Week 28
    End point description
    The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS (other than akathisia) and other safety or tolerability issues. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable. The sum of the 12 items ranged from 12 (the current medication was much better than previous antipsychotic medication) to 60 (the current medication was much worse than previous antipsychotic medication).
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Aripiprazol Paliperidone
    Number of subjects analysed
    133
    131
    Units: units on a scale
        least squares mean (standard error)
    32.32 ( 0.52 )
    33.81 ( 0.55 )
    Statistical analysis title
    		 Aripiprazol vs Paliperidone
    Comparison groups
    Aripiprazol v Paliperidone
    Number of subjects included in analysis
    264
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.043
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -1.492
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.935
         upper limit
    		 -0.049

    Secondary: Change From Baseline to Week 28 in CGI-S Score

    		 Close Top of page
    End point title
    		 Change From Baseline to Week 28 in CGI-S Score
    End point description
    Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 28
    End point values
    		 Aripiprazol Paliperidone
    Number of subjects analysed
    136
    132
    Units: units on a scale
        least squares mean (standard error)
    -0.75 ( 0.07 )
    -0.46 ( 0.07 )
    Statistical analysis title
    		 Aripiprazol vs Paliperidone
    Comparison groups
    Aripiprazol v Paliperidone
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.283
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.477
         upper limit
    		 -0.09

    Secondary: Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score

    		 Close Top of page
    End point title
    		 Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score
    End point description
    The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning
    End point type
    Secondary
    End point timeframe
    Baseline, Week 28
    End point values
    		 Aripiprazol Paliperidone
    Number of subjects analysed
    136
    132
    Units: units on a scale
        least squares mean (standard error)
    0.52 ( 0.16 )
    0.18 ( 0.17 )
    Statistical analysis title
    		 Aripiprazol vs Paliperidone
    Comparison groups
    Aripiprazol v Paliperidone
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.149
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.331
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.782

    Secondary: Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score

    		 Close Top of page
    End point title
    		 Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score
    End point description
    The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 28
    End point values
    		 Aripiprazol Paliperidone
    Number of subjects analysed
    136
    132
    Units: units on a scale
        least squares mean (standard error)
    2.25 ( 0.59 )
    0.5 ( 0.63 )
    Statistical analysis title
    		 Aripiprazol vs Paliperidone
    Comparison groups
    Aripiprazol v Paliperidone
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.039
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    1.753
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.093
         upper limit
    		 3.412

    Secondary: Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score

    		 Close Top of page
    End point title
    		 Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score
    End point description
    The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning
    End point type
    Secondary
    End point timeframe
    Baseline, Week 28
    End point values
    		 Aripiprazol Paliperidone
    Number of subjects analysed
    136
    132
    Units: units on a scale
        least squares mean (standard error)
    3.24 ( 0.68 )
    1.47 ( 0.72 )
    Statistical analysis title
    		 Aripiprazol vs Paliperidone
    Comparison groups
    Aripiprazol v Paliperidone
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.07
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    1.764
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.143
         upper limit
    		 3.672

    Secondary: Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score

    		 Close Top of page
    End point title
    		 Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score
    End point description
    The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 28
    End point values
    		 Aripiprazol Paliperidone
    Number of subjects analysed
    136
    132
    Units: units on a scale
        least squares mean (standard error)
    1.76 ( 0.42 )
    0.83 ( 0.45 )
    Statistical analysis title
    		 Aripiprazol vs Paliperidone
    Comparison groups
    Aripiprazol v Paliperidone
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.13
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.922
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.275
         upper limit
    		 2.119

    Secondary: Change From Baseline to Week 28 in SWN-S Total Score

    		 Close Top of page
    End point title
    		 Change From Baseline to Week 28 in SWN-S Total Score
    End point description
    The SWN-S is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 28
    End point values
    		 Aripiprazol Paliperidone
    Number of subjects analysed
    136
    132
    Units: units on a scale
        least squares mean (standard error)
    4.82 ( 1.24 )
    3.81 ( 1.31 )
    Statistical analysis title
    		 Aripiprazol vs Paliperidone
    Comparison groups
    Aripiprazol v Paliperidone
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.561
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    1.007
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.402
         upper limit
    		 4.417

    Secondary: Change From Baseline to Week 28 in the TooL Total Score

    		 Close Top of page
    End point title
    		 Change From Baseline to Week 28 in the TooL Total Score
    End point description
    Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 28
    End point values
    		 Aripiprazol Paliperidone
    Number of subjects analysed
    136
    132
    Units: units on a scale
        least squares mean (standard error)
    -1.75 ( 0.3 )
    -1.05 ( 0.32 )
    Statistical analysis title
    		 Aripiprazol vs Paliperidone
    Comparison groups
    Aripiprazol v Paliperidone
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.095
    Method
    		 Mixed models analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.695
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.511
         upper limit
    		 0.121

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    First dose to follow-up
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    PALIPERIDONE
    Reporting group description
    		 PALIPERIDONE

    Reporting group title
    ARIPIPRAZOLE
    Reporting group description
    		 ARIPIPRAZOLE

    Serious adverse events
    		 PALIPERIDONE ARIPIPRAZOLE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 137 (7.30%)
    12 / 144 (8.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Nasopharyngeal cancer
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cirrhosis alcoholic
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    4 / 137 (2.92%)
    5 / 144 (3.47%)
         occurrences causally related to treatment / all
    3 / 4
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 137 (0.73%)
    5 / 144 (3.47%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 144 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PALIPERIDONE ARIPIPRAZOLE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    74 / 137 (54.01%)
    65 / 144 (45.14%)
    Investigations
    Weight increased
         subjects affected / exposed
    19 / 137 (13.87%)
    13 / 144 (9.03%)
         occurrences all number
    21
    13
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    13 / 137 (9.49%)
    30 / 144 (20.83%)
         occurrences all number
    15
    37
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    12 / 137 (8.76%)
    5 / 144 (3.47%)
         occurrences all number
    12
    5
    Akathisia
         subjects affected / exposed
    6 / 137 (4.38%)
    8 / 144 (5.56%)
         occurrences all number
    8
    10
    Headache
         subjects affected / exposed
    11 / 137 (8.03%)
    3 / 144 (2.08%)
         occurrences all number
    12
    3
    Somnolence
         subjects affected / exposed
    8 / 137 (5.84%)
    9 / 144 (6.25%)
         occurrences all number
    8
    10
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 137 (5.11%)
    4 / 144 (2.78%)
         occurrences all number
    8
    5
    Injection site pain
         subjects affected / exposed
    11 / 137 (8.03%)
    4 / 144 (2.78%)
         occurrences all number
    14
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 137 (5.84%)
    3 / 144 (2.08%)
         occurrences all number
    9
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    12 / 137 (8.76%)
    8 / 144 (5.56%)
         occurrences all number
    13
    9
    Insomnia
         subjects affected / exposed
    17 / 137 (12.41%)
    17 / 144 (11.81%)
         occurrences all number
    19
    21
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 137 (5.84%)
    6 / 144 (4.17%)
         occurrences all number
    9
    6

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Sep 2013
    Adjustment of the study design (including the addition of up to 2 further cohorts and therefore a change in the number of subjects planned) to explore and better define the safety window of Lu AF34134 Timing of Change: Prior to Cohort 5

    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
    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-Sat May 10 03:44:54 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA