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    Clinical Trial Results:
    A Long-Term Multicenter, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients with Schizophrenia

    Summary
    EudraCT number
    2010-020987-39
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    12 Dec 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Mar 2016
    First version publication date
    09 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    31-09-266
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01149655
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Sponsor organisation address
    2440 Research Boulevard, Rockville, United States, Maryland 20850
    Public contact
    Matthew Media Group, Matthew Media Group, ATTAINstudyinfo@mmgct.com
    Scientific contact
    Matthew Media Group, Matthew Media Group, ATTAINstudyinfo@mmgct.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000235-PIP02-10
    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
    12 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of aripiprazole compared with placebo, as measured by time to exacerbation of psychotic symptoms/impending relapse, in adolescent schizophrenic subjects who have maintained stability for 2 consecutive weekly time points on oral aripiprazole with at least 7 weeks of treatment. The secondary objective was to evaluate the safety and tolerability of oral aripiprazole as maintenance treatment in adolescent participants with schizophrenia.
    Protection of trial subjects
    The study was conducted in accordance with the protocol, legal and regulatory requirements, as well as in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines for conducting, recording, and reporting clinical studies. Consistent with ethical principles for the protection of human research participants, no study procedures were performed on study candidates until written consent had been obtained from them. The informed consent form (ICF), protocol, and amendments for this study were submitted to and approved by the institutional review board (IRB) or independent ethics committee (IEC) for each respective trial site or country.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Aug 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    United States: 12
    Country: Number of subjects enrolled
    India: 59
    Country: Number of subjects enrolled
    Malaysia: 3
    Country: Number of subjects enrolled
    Philippines: 15
    Country: Number of subjects enrolled
    Romania: 21
    Country: Number of subjects enrolled
    Russian Federation: 89
    Worldwide total number of subjects
    201
    EEA total number of subjects
    21
    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)
    201
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 244 participants were screened, 201 entered the trial and 146 were randomized into the double-blind maintenance phase. The participants were recruited from 69 trial sites in the United States of America, Russia, Romania, India, Philippines, Malaysia, and Taiwan.

    Pre-assignment
    Screening details
    Participants were titrated to oral aripiprazole in Period 1. Participants who converted to aripiprazole and who already received aripiprazole were in Period 2. Participants met stability criteria were randomized in 2:1 ratio (aripiprazole: placebo) in Period 3. Disposition presented for the overall study.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    During the double-blind phase, treatment assignment code list was available only to an independent biostatistician and the clinical supply operations group. All other personnel were blinded to the identity of the treatment assignments until every participant had completed trial treatment and the database was locked.

    Arms
    Arm title
    All participants
    Arm description
    Data for all participants was analysed
    Arm type
    Experimental

    Investigational medicinal product name
    Aripiprazole
    Investigational medicinal product code
    Other name
    Abilify, OPC-14597
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who had received oral aripiprazole 2 to 10 milligram (mg) for 2 Weeks in combination with any other antipsychotic were in conversion phase. Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg per day for 2 Weeks. Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole titrated from 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.

    Number of subjects in period 1
    All participants
    Started
    201
    Completed
    21
    Not completed
    180
         Lack of efficacy or relapse
    37
         Adverse event without lack of efficacy
    11
         Physician decision
    6
         Met withdrawal criteria
    8
         Sponsor discontinued trial
    97
         Consent withdrawn by subject
    20
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All participants
    Reporting group description
    Data for all participants was analysed

    Reporting group values
    All participants Total
    Number of subjects
    201 201
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    15.1 ± 1.2 -
    Gender categorical
    Units: Subjects
        Female
    68 68
        Male
    133 133

    End points

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    End points reporting groups
    Reporting group title
    All participants
    Reporting group description
    Data for all participants was analysed

    Subject analysis set title
    Aripiprazole double-blind maintenance
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The Intent-to-Treat (ITT) data set comprised all participants randomized to the double-blind treatment.

    Subject analysis set title
    Placebo double-blind maintenance
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The ITT data set comprised all subjects randomized to the double-blind treatment.

    Primary: Overall relapse rate (in percent) from randomization to exacerbation of psychotic symptoms/impending relapse.

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    End point title
    Overall relapse rate (in percent) from randomization to exacerbation of psychotic symptoms/impending relapse.
    End point description
    Overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behaviour, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behaviour or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behaviour resulting in clinically significant injury. The intent-to-treat (ITT) population was analysed.
    End point type
    Primary
    End point timeframe
    Baseline to Week 55/End of Double-Blind phase visit
    End point values
    All participants Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    146
    98
    48
    Units: Percent
        number (not applicable)
    25.3
    19.39
    37.5
    Statistical analysis title
    Statistical analysis 1 at Week 52
    Statistical analysis description
    ITT data set was used for the analysis. Participants who were lost to follow-up or who were still in the study at the end of Week 52 were considered as censored on their date of last efficacy evaluation. The ITT set comprised participants randomized to the double-blind phase. Total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 randomization ratio to achieve at least 80% power and to preserve overall nominal alpha level of 0.05 (2-sided).
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.0161
    Method
    Logrank
    Parameter type
    Cox proportional hazard
    Point estimate
    0.461
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.242
         upper limit
    0.879
    Notes
    [1] - Hazard ratios and their 95% confidence intervals were derived from the Cox Proportional Hazard model with treatment as term. Hazard ratio < 1 is in favour of oral aripiprazole 10-30 mg group for superiority test.

    Secondary: Percentage of participants meeting exacerbation of psychotic symptoms/impending relapse criteria.

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    End point title
    Percentage of participants meeting exacerbation of psychotic symptoms/impending relapse criteria.
    End point description
    Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behaviour or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behaviour resulting in clinically significant injury. The ITT data set comprised of all participants who were randomised to the double-blind phase.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52/End of Double-Blind phase visit.
    End point values
    Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    98
    48
    Units: Percentage
    number (not applicable)
        CGI-I + PANSS
    16.33
    33.33
        CGI-I of 6 of 7
    11.22
    25
        Hospitalisation
    1.02
    10.42
        Suicidal behaviour
    1.02
    0
        Violent behaviour
    4.08
    10.42
    No statistical analyses for this end point

    Secondary: Percentage of participants who had achieved remission.

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    End point title
    Percentage of participants who had achieved remission.
    End point description
    Percentage of participants who had achieved remission, where remission was defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions, unusual thought content, hallucinatory behaviour, conceptual disorganization, mannerisms/ posturing, blunted affect, social withdrawal, and lack of spontaneity. The ITT data set comprised of all participants who were randomised to the double-blind phase. For evaluation of remission, 48 of 98 aripiprazole participants and 19 of 48 placebo participants met the 6 month threshold for remission analysis. Of those, 21 of 48 aripiprazole participants and 8 of 19 placebo participants met criteria for remission.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52/End of Double-Blind phase visit.
    End point values
    Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    48
    19
    Units: Percentage of participants
        number (not applicable)
    43.8
    42.1
    Statistical analysis title
    Statistical analysis 1 at Week 52
    Statistical analysis description
    The ITT data set comprised of participants who were randomized to the double-blind treatment. For evaluation of remission, 48 of 98 aripiprazole participants and 19 of 48 placebo participants met the 6 month threshold for remission analysis. Of those, 21 of 48 aripiprazole participants and 8 of 19 placebo participants met criteria for remission.
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    = 0.9025
    Method
    Chi-squared
    Confidence interval
    Notes
    [2] - The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).

    Secondary: Percentage of participants who discontinued due to all reasons other than sponsor discontinued Study.

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    End point title
    Percentage of participants who discontinued due to all reasons other than sponsor discontinued Study.
    End point description
    Percentage of participants discontinued due to all reasons other than sponsor discontinued study were noted. The ITT data set comprised of all participants who were randomised to the double-blind phase.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52/End of Double-Blind phase visit
    End point values
    Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    98
    48
    Units: Percentage
        number (not applicable)
    25.51
    47.92
    Statistical analysis title
    Statistical analysis 1 at Week 52
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0076
    Method
    Logrank
    Confidence interval

    Secondary: Mean change from Baseline to endpoint in PANSS total score.

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    End point title
    Mean change from Baseline to endpoint in PANSS total score.
    End point description
    The PANSS consisted of 3 subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale were positive subscale, negative subscale and general psychopathology subscale. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The ITT data set comprised of participants randomized to double-blind period. LOCF (last observation carried forward) method was used to impute missing data. Week 1 had only 95 and 45 participants analysed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52/End of Double-Blind phase visit.
    End point values
    Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    98 [3]
    48 [4]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 1
    0.22 ± 5.62
    -0.27 ± 4.66
        Week 2
    0.09 ± 5.77
    -0.58 ± 6.01
        Week 3
    -0.36 ± 6.41
    1.81 ± 9.66
        Week 4
    -0.64 ± 6.9
    1.56 ± 11.13
        Week 6
    -1.2 ± 8.28
    2.92 ± 13.39
        Week 8
    -1.62 ± 9.2
    3.71 ± 14.29
        Week 10
    -1.2 ± 9.61
    3.9 ± 14.8
        Week 12
    -0.19 ± 10.57
    4.52 ± 16.17
        Week 14
    -0.18 ± 11.06
    5.5 ± 17.21
        Week 16
    -0.78 ± 11.72
    5.56 ± 17.33
        Week 18
    -0.68 ± 12.3
    5.57 ± 17.24
        Week 20
    -0.57 ± 12.46
    6.06 ± 17.84
        Week 22
    -0.31 ± 12.37
    6.1 ± 18.98
        Week 24
    -0.36 ± 12.36
    5.92 ± 19.22
        Week 26
    -0.88 ± 12.41
    5.81 ± 19.65
        Week 28
    -0.85 ± 12.52
    5.65 ± 19.82
        Week 30
    -0.96 ± 12.71
    5.6 ± 19.96
        Week 32
    -0.99 ± 12.74
    6.21 ± 20.43
        Week 34
    -1.12 ± 13.05
    5.79 ± 19.85
        Week 36
    -0.55 ± 13.04
    5.4 ± 20.2
        Week 38
    -0.84 ± 13.17
    5.21 ± 20.27
        Week 40
    -0.92 ± 13.21
    5.1 ± 20.34
        Week 42
    -1.14 ± 13.26
    4.94 ± 20.36
        Week 44
    -0.96 ± 13.32
    4.88 ± 20.47
        Week 46
    -1.02 ± 13.35
    4.83 ± 20.54
        Week 48
    -0.99 ± 13.34
    4.67 ± 20.72
        Week 50
    -1.19 ± 13.43
    4.71 ± 20.66
        Week 52
    -1.31 ± 13.47
    4.79 ± 20.6
    Notes
    [3] - At Week 1, data were available for 55 participants
    [4] - At Week 1, data were available for 45 participants
    No statistical analyses for this end point

    Secondary: Mean change from Baseline to endpoint in PANSS negative subscale.

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    End point title
    Mean change from Baseline to endpoint in PANSS negative subscale.
    End point description
    The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 negative symptom constructs were blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The ITT data set comprised of participants randomized to the double-blind phase. LOCF method was used to impute missing data. Week 1 participants analysed were 94 and 45.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52/End of Double-Blind phase visit.
    End point values
    Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    98
    48
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 1 (Aripiprazole N= 95, Placebo N= 45)
    0.03 ± 1.57
    -0.09 ± 1.4
        Week 2
    -0.07 ± 1.68
    -0.23 ± 2.35
        Week 3
    -0.39 ± 1.89
    0.48 ± 3.17
        Week 4
    -0.27 ± 2.12
    0.44 ± 3.41
        Week 6
    -0.42 ± 2.37
    0.9 ± 3.57
        Week 8
    -0.41 ± 2.37
    0.77 ± 3.76
        Week 10
    -0.33 ± 2.47
    0.71 ± 3.82
        Week 12
    -0.38 ± 2.91
    0.79 ± 0.79
        Week 14
    -0.41 ± 3.13
    1.15 ± 4.63
        Week 16
    -0.51 ± 3.31
    1.19 ± 4.77
        Week 18
    -0.47 ± 3.45
    1.19 ± 4.77
        Week 20
    -0.47 ± 3.54
    1.1 ± 4.93
        Week 22
    -0.43 ± 3.55
    1.06 ± 5.26
        Week 24
    -0.42 ± 3.54
    0.79 ± 5.41
        Week 26
    -0.54 ± 3.6
    0.81 ± 5.43
        Week 28
    -0.51 ± 3.63
    0.83 ± 5.43
        Week 30
    -0.56 ± 3.57
    0.67 ± 5.55
        Week 32
    -0.52 ± 3.6
    0.98 ± 5.89
        Week 34
    -0.64 ± 3.68
    0.56 ± 0.56
        Week 36
    -0.47 ± 3.71
    0.65 ± 5.69
        Week 38
    -0.62 ± 0.37
    0.54 ± 5.84
        Week 40
    -0.64 ± 3.78
    0.54 ± 5.78
        Week 42
    0.77 ± 3.79
    0.42 ± 5.75
        Week 44
    -0.72 ± 3.87
    0.46 ± 5.76
        Week 46
    -0.68 ± 3.84
    0.35 ± 5.83
        Week 48
    -0.73 ± 3.83
    0.33 ± 5.88
        Week 50
    -0.8 ± 3.84
    0.29 ± 5.96
        Week 52
    -0.78 ± 3.81
    0.4 ± 5.87
    No statistical analyses for this end point

    Secondary: Percentage of responders in each treatment group

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    End point title
    Percentage of responders in each treatment group
    End point description
    Percentage of responders in each treatment group (i.e, response defined as meeting stability criteria). Participants stabilized on aripiprazole (trial drug) within the approved dose range of 10 to 30 mg/day and are tolerable based on clinical judgment. The ITT data set comprised of all participants who were randomised to the double-blind phase.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52/End of Double-Blind phase visit
    End point values
    Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    98
    48
    Units: Percentage
    number (not applicable)
        Week 1 (Arirpiprazole N= 95, Placebo
    96.8
    97.8
        Week 2 (N= 91, 46)
    92.3
    95.7
        Week 3 (N= 86, 45)
    93
    86.7
        Week 4 (N= 91, 43)
    93.4
    90.7
        Week 6 (N= 87, 41)
    90.8
    92.7
        Week 8 (N= 82, 38)
    97.6
    89.5
        Week 10 (N= 74, 32)
    94.6
    93.8
        Week 12 (N= 71, 30)
    94.4
    93.3
        Week 14 (N= 68, 26)
    94.1
    92.3
        Week 16 (N= 65, 25)
    96.9
    96
        Week 18 (N= 59, 23)
    94.9
    91.3
        Week 20 (N= 57, 23)
    94.7
    91.3
        Week 22 (N= 55, 21)
    92.7
    95.2
        Week 24 (N= 51, 19)
    98
    100
        Week 26 (N= 48, 19)
    97.9
    100
        Week 28 (N= 42, 17)
    97.6
    100
        Week 30 (N= 40, 16)
    95
    100
        Week 32 (N= 39, 16)
    94.9
    93.8
        Week 34 (N= 38, 14)
    94.7
    100
        Week 36 (N= 36, 15)
    94.4
    100
        Week 38 (N= 33, 12)
    100
    100
        Week 40 (N= 29, 11)
    100
    100
        Week 42 (N= 27, 11)
    100
    100
        Week 44 (N= 21, 8)
    100
    100
        Week 46 (N= 18, 8)
    88.9
    100
        Week 48 (N= 17, 8)
    94.1
    100
        Week 50 (N= 17, 6)
    88.2
    100
        Week 52 (N= 14, 7)
    100
    100
        Last Visit (N= 98, 48)
    77.6
    64.6
    Statistical analysis title
    Statistical analysis 1 at Last Visit
    Statistical analysis description
    Statistical Analysis for Last Visit. The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0962
    Method
    Chi-squared
    Confidence interval

    Other pre-specified: Mean change from Baseline to endpoint in CGI-S score.

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    End point title
    Mean change from Baseline to endpoint in CGI-S score.
    End point description
    The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-s, the Investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0= not assessed; 1= normal, not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants. The ITT data set comprised of participants randomised to the double-blind phase. LOCF method was used to impute missing data. Week 1 participants analysed were 94 and 45 and Week 2 to Week 52 participants analysed were 97 and 48.
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 52/End of Double-Blind Phase visit.
    End point values
    Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    98
    48
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 1 (Aripiprazole N= 94, Placebo N= 45)
    0.01 ± 0.23
    0.02 ± 0.34
        Week 2 (N= 97, 48)
    0 ± 0.32
    0.02 ± 0.44
        Week 3
    0.01 ± 0.4
    0.13 ± 0.64
        Week 4
    0.03 ± 0.44
    0.1 ± 0.69
        Week 6
    0.44 ± 0.52
    0.15 ± 0.77
        Week 8
    0.04 ± 0.63
    0.19 ± 0.79
        Week 10
    0.02 ± 0.71
    0.25 ± 0.81
        Week 12
    0.05 ± 0.77
    0.31 ± 0.85
        Week 14
    0.03 ± 0.78
    0.35 ± 1.04
        Week 16
    0.02 ± 0.83
    0.33 ± 1.06
        Week 18
    0.04 ± 0.83
    0.35 ± 1.06
        Week 20
    0.05 ± 0.85
    0.4 ± 1.12
        Week 22
    0.08 ± 0.87
    0.38 ± 1.14
        Week 24
    0.06 ± 0.88
    0.35 ± 1.18
        Week 26
    0.05 ± 0.89
    0.35 ± 1.18
        Week 28
    0.05 ± 0.92
    0.33 ± 1.19
        Week 30
    0.04 ± 0.91
    0.33 ± 1.19
        Week 32
    0.04 ± 0.92
    0.31 ± 1.21
        Week 34
    0.05 ± 0.93
    0.29 ± 1.22
        Week 36
    0.07 ± 0.95
    0.29 ± 1.22
        Week 38
    0.07 ± 0.95
    0.29 ± 1.22
        Week 40
    0.07 ± 0.95
    0.29 ± 1.22
        Week 42
    0.06 ± 0.94
    0.29 ± 1.22
        Week 44
    0.08 ± 0.95
    0.31 ± 1.21
        Week 46
    0.07 ± 0.95
    0.31 ± 1.21
        Week 48
    0.06 ± 0.94
    0.29 ± 1.22
        Week 50
    0.05 ± 0.95
    0.27 ± 1.25
        Week 52
    0.05 ± 0.95
    0.29 ± 1.22
    No statistical analyses for this end point

    Other pre-specified: Mean CGI-I score at endpoint.

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    End point title
    Mean CGI-I score at endpoint.
    End point description
    Baseline for the double-blind maintenance phase was defined as the last visit with available data in the stabilization phase, and the CGI-I scale was completed prior to or on the first dose date in the double-blind maintenance phase. Response choices included: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse. The ITT data set comprised of participants randomised to double-blind phase. LOCF method was used to impute missing data. Week 1 participants analysed were 94 and 45 and Week 2 to Week 52 participants analysed were 97 and 48.
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 52/End of Double-Blind phase visit.
    End point values
    Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    98
    48
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    2.4 ± 0.8
    2.52 ± 0.82
        Week 1 (Aripiprazole N= 94, Placebo N= 45)
    3.49 ± 0.84
    3.51 ± 0.84
        Week 2 (N= 97, 48)
    3.48 ± 0.88
    3.52 ± 0.95
        Week 3
    3.47 ± 0.89
    3.63 ± 1.06
        Week 4
    3.6 ± 0.92
    3.6 ± 1.2
        Week 6
    3.53 ± 1
    3.73 ± 1.3
        Week 8
    3.46 ± 1.09
    3.83 ± 1.45
        Week 10
    3.38 ± 1.13
    3.9 ± 1.49
        Week 12
    3.45 ± 1.19
    3.96 ± 1.44
        Week 14
    3.44 ± 1.23
    4.04 ± 1.56
        Week 16
    3.32 ± 1.25
    4 ± 1.57
        Week 18
    3.35 ± 1.29
    4.02 ± 1.58
        Week 20
    3.4 ± 1.3
    4.08 ± 1.54
        Week 22
    3.43 ± 1.34
    4.04 ± 1.6
        Week 24
    3.41 ± 1.31
    4.08 ± 1.6
        Week 26
    3.41 ± 1.34
    4.04 ± 1.6
        Week 28
    3.43 ± 1.34
    4.02 ± 4.02
        Week 30
    3.44 ± 1.36
    4 ± 1.66
        Week 32
    3.46 ± 1.37
    3.98 ± 1.68
        Week 34
    3.47 ± 1.36
    3.94 ± 1.71
        Week 36
    3.48 ± 1.39
    3.94 ± 1.71
        Week 38
    3.45 ± 1.38
    3.94 ± 1.71
        Week 40
    3.45 ± 1.38
    3.92 ± 1.72
        Week 42
    3.45 ± 1.38
    3.92 ± 1.72
        Week 44
    3.45 ± 1.38
    3.94 ± 1.71
        Week 46
    3.46 ± 1.37
    3.94 ± 1.71
        Week 48
    3.46 ± 1.38
    3.92 ± 1.72
        Week 50
    3.46 ± 1.38
    3.92 ± 1.72
        Week 52
    3.42 ± 1.39
    3.92 ± 1.72
    Statistical analysis title
    Statistical analysis at Baseline
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3862 [5]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [5] - The Cochran-Mantel-Haenszel (CMH) method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 1
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8861 [6]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [6] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 2
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8189 [7]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [7] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 3
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3689 [8]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [8] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 4
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9723 [9]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [9] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 6
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2985 [10]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [10] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 8
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0883 [11]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [11] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 10
    Comparison groups
    Placebo double-blind maintenance v Aripiprazole double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0228 [12]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [12] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 12
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0274 [13]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [13] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 14
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0135 [14]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [14] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 16
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0059 [15]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [15] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 18
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0076 [16]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [16] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 20
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0065 [17]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [17] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 22
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0175 [18]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [18] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 24
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0107 [19]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [19] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 26
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0118 [20]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [20] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 28
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0232 [21]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [21] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 30
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0337 [22]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [22] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 32
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0507 [23]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [23] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 34
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0791 [24]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [24] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 36
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0898 [25]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [25] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 38
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0686 [26]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [26] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 40
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0833 [27]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [27] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 42
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0824 [28]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [28] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 44
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0686 [29]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [29] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 46
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0737 [30]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [30] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 48
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0893 [31]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [31] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 50
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0706 [32]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [32] - CMH method was based on raw mean score statistics.
    Statistical analysis title
    Statistical analysis at Week 52
    Comparison groups
    Aripiprazole double-blind maintenance v Placebo double-blind maintenance
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0657 [33]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [33] - CMH method was based on raw mean score statistics.

    Other pre-specified: Mean change from Baseline to endpoint in PANSS positive subscale.

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    End point title
    Mean change from Baseline to endpoint in PANSS positive subscale.
    End point description
    The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 positive symptom constructs were delusions, conceptual disorganization, hallucinatory behaviour, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The ITT data set comprised of participants randomised to the double-blind phase. LOCF method was used to impute missing data. Week 1 participants analysed were 94 and 45.
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 52/End of Double-Blind phase visit.
    End point values
    Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    98
    48
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 1 (Aripiprazole N= 95, Placebo N= 45)
    0.08 ± 1.84
    0.07 ± 2.41
        Week 2
    0.09 ± 2.05
    -0.04 ± 2.87
        Week 3
    0.01 ± 2.36
    0.56 ± 3.34
        Week 4
    -0.12 ± 2.65
    0.58 ± 3.8
        Week 6
    -0.2 ± 2.9
    1.1 ± 4.85
        Week 8
    -0.19 ± 3.23
    1.56 ± 5.11
        Week 10
    -0.16 ± 3.28
    1.63 ± 5.45
        Week 12
    0.23 ± 3.58
    1.96 ± 5.78
        Week 14
    0.28 ± 3.77
    2.27 ± 6.03
        Week 16
    0.32 ± 3.77
    2.17 ± 6.05
        Week 18
    0.24 ± 3.98
    2.15 ± 6.14
        Week 20
    0.18 ± 4
    2.44 ± 6.32
        Week 22
    0.39 ± 4.12
    2.6 ± 6.44
        Week 24
    0.38 ± 4.23
    2.65 ± 6.36
        Week 26
    0.22 ± 4.23
    2.58 ± 6.45
        Week 28
    0.17 ± 4.28
    2.56 ± 6.51
        Week 30
    0.22 ± 4.41
    2.6 ± 6.59
        Week 32
    0.18 ± 4.45
    2.71 ± 6.64
        Week 34
    0.29 ± 4.45
    2.58 ± 2.58
        Week 36
    0.22 ± 4.55
    2.48 ± 6.6
        Week 38
    0.27 ± 4.56
    2.46 ± 6.63
        Week 40
    0.24 ± 4.52
    2.44 ± 6.69
        Week 42
    0.27 ± 4.52
    2.35 ± 6.73
        Week 44
    0.27 ± 4.52
    2.33 ± 6.76
        Week 46
    0.21 ± 4.52
    2.42 ± 6.69
        Week 48
    0.3 ± 4.53
    2.29 ± 6.77
        Week 50
    0.2 ± 4.52
    2.33 ± 6.75
        Week 52
    0.16 ± 4.55
    6.75 ± 6.75
    No statistical analyses for this end point

    Other pre-specified: Mean change from Baseline to endpoint in Children's Global Assessment Scale (CGAS).

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    End point title
    Mean change from Baseline to endpoint in Children's Global Assessment Scale (CGAS).
    End point description
    The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS is a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. CGAS score (range 1-100) was a single item score for rating a child's general level of functioning on a health-illness continuum, with higher scores represented better functioning. The ITT data set comprised of participants randomised to the double-blind phase. LOCF method was used to impute missing data. Week 1 participants analysed were 95 and 45.
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 52/End of Double-Blind phase visit.
    End point values
    Aripiprazole double-blind maintenance Placebo double-blind maintenance
    Number of subjects analysed
    98
    48
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 1 (Aripiprazole N= 95, Placebo N= 45)
    0 ± 2.74
    -0.09 ± 2.02
        Week 2
    -0.1 ± 3.9
    -0.31 ± 4.03
        Week 3
    0.35 ± 4.36
    -1.04 ± 7.21
        Week 4
    0.29 ± 5.22
    -1.23 ± 7.78
        Week 6
    0.4 ± 6.01
    -2.08 ± 9.14
        Week 8
    0.98 ± 6.9
    -2.4 ± 9.93
        Week 10
    1.11 ± 7.47
    -2.31 ± 11.63
        Week 12
    1.08 ± 8.21
    -2.85 ± 11.4
        Week 14
    1.06 ± 8.49
    -3.52 ± 12.4
        Week 16
    1.57 ± 8.69
    -2.69 ± 12.96
        Week 18
    1.55 ± 9.41
    -2.9 ± 13.07
        Week 20
    1.28 ± 9.88
    -4.06 ± 14.84
        Week 22
    1.17 ± 10.15
    -3.77 ± 15.05
        Week 24
    1.33 ± 10.33
    -3.67 ± 15.2
        Week 26
    1.61 ± 10.37
    -3.69 ± 15.29
        Week 28
    1.73 ± 10.73
    -3.75 ± 15.26
        Week 30
    1.92 ± 10.89
    -3.44 ± 15.45
        Week 32
    1.86 ± 11.03
    -3.33 ± 15.47
        Week 34
    2.05 ± 11.19
    -3 ± 15.85
        Week 36
    1.87 ± 11.41
    -3.1 ± 15.7
        Week 38
    2 ± 11.59
    -2.85 ± 15.95
        Week 40
    1.9 ± 11.68
    -2.85 ± 15.99
        Week 42
    1.9 ± 11.74
    -2.69 ± 16.17
        Week 44
    1.83 ± 11.86
    -2.67 ± 16.18
        Week 46
    2.13 ± 11.74
    -2.67 ± 16.17
        Week 48
    2.17 ± 11.79
    -2.4 ± 16.42
        Week 50
    2.29 ± 11.74
    -2.31 ± 16.51
        Week 52
    2.35 ± 11.85
    -2.25 ± 16.58
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were recorded from the time the informed consent form was signed (with 4-Week Post-Trial Follow-up).
    Adverse event reporting additional description
    Serious adverse event was any untoward medical occurrence that results in death, was life-threatening, required inpatient hospitalisation or prolonged hospitalisation. An AE was an exacerbation of existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by physician.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Aripiprazole-Conversion Phase
    Reporting group description
    Participants had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.

    Reporting group title
    Aripiprazole-Stabilisation Phase
    Reporting group description
    Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.

    Reporting group title
    Aripiprazole-Double Blind Maintenance Treatment
    Reporting group description
    Participants who met stability criteria in period 2 (stabilisation phase) had received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).

    Reporting group title
    Placebo-Double Blind Maintenance Treatment
    Reporting group description
    Participants who met stability criteria in period 2 (stabilisation phase) had received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).

    Serious adverse events
    Aripiprazole-Conversion Phase Aripiprazole-Stabilisation Phase Aripiprazole-Double Blind Maintenance Treatment Placebo-Double Blind Maintenance Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 186 (1.08%)
    4 / 183 (2.19%)
    3 / 98 (3.06%)
    6 / 48 (12.50%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 183 (0.55%)
    0 / 98 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Hallucinations, mixed
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 183 (0.00%)
    0 / 98 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 186 (0.00%)
    1 / 183 (0.55%)
    2 / 98 (2.04%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 186 (0.54%)
    2 / 183 (1.09%)
    1 / 98 (1.02%)
    5 / 48 (10.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Aripiprazole-Conversion Phase Aripiprazole-Stabilisation Phase Aripiprazole-Double Blind Maintenance Treatment Placebo-Double Blind Maintenance Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 186 (27.96%)
    56 / 183 (30.60%)
    41 / 98 (41.84%)
    25 / 48 (52.08%)
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 186 (0.00%)
    13 / 183 (7.10%)
    8 / 98 (8.16%)
    5 / 48 (10.42%)
         occurrences all number
    0
    14
    8
    5
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    11 / 186 (5.91%)
    14 / 183 (7.65%)
    3 / 98 (3.06%)
    3 / 48 (6.25%)
         occurrences all number
    11
    16
    3
    3
    Headache
         subjects affected / exposed
    12 / 186 (6.45%)
    13 / 183 (7.10%)
    6 / 98 (6.12%)
    4 / 48 (8.33%)
         occurrences all number
    14
    13
    6
    4
    Somnolence
         subjects affected / exposed
    19 / 186 (10.22%)
    12 / 183 (6.56%)
    0 / 98 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    23
    12
    0
    0
    Tremor
         subjects affected / exposed
    6 / 186 (3.23%)
    13 / 183 (7.10%)
    4 / 98 (4.08%)
    4 / 48 (8.33%)
         occurrences all number
    6
    16
    4
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    16 / 186 (8.60%)
    14 / 183 (7.65%)
    5 / 98 (5.10%)
    9 / 48 (18.75%)
         occurrences all number
    16
    16
    5
    14
    Psychotic disorder
         subjects affected / exposed
    1 / 186 (0.54%)
    0 / 183 (0.00%)
    7 / 98 (7.14%)
    4 / 48 (8.33%)
         occurrences all number
    1
    0
    7
    4
    Schizophrenia
         subjects affected / exposed
    1 / 186 (0.54%)
    6 / 183 (3.28%)
    9 / 98 (9.18%)
    8 / 48 (16.67%)
         occurrences all number
    1
    6
    9
    8
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 186 (0.00%)
    0 / 183 (0.00%)
    1 / 98 (1.02%)
    3 / 48 (6.25%)
         occurrences all number
    0
    0
    1
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 186 (0.00%)
    0 / 183 (0.00%)
    7 / 98 (7.14%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    8
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Apr 2011
    This amendment included a new warning from the European Summary of Product Characteristics on venous thromboembolism and an explanation of the occurrence of suicidal behaviour in participants with psychotic illnesses; to provide clearer instructions to investigators on trial procedures; to correct several errors in the protocol that were inconsistent with the Schedule of Trial Assessments.
    20 Nov 2012
    The aim of this amendment was: to reduce the statistical power of the trial from 90% to 80% while keeping the randomization ratio at 2:1 to limit the number of participants exposed to placebo. Consequently, the total number of events was reduced from 49 to 37. The total number of randomized participants was decreased from 138 to 105: in the aripiprazole group, from 96 to 70, and in the placebo group, from 48 to 35; to reduce the number of interim analyses from two to one; to extend the 2-year recruitment period by 1 year, making it a 3-year recruitment period; to add a missing “not” to Inclusion Criterion #3 “as long as the subject does not require prohibited medication.”; to update the protocol amendment with information from the aripiprazole Investigator Brochure, Version No. 16; to update the protocol amendment with text from the new protocol template; to remove mention of collecting thyroid stimulating hormone at the conversion phase baseline visit; to make clarifications about the following: (1) stability criterion 5, (2) the intent-to-treat Population, (3) the rationale for using aripiprazole doses higher than 15 mg, (4) the minimum duration of aripiprazole exposure needed with the 2 weeks of stabilization, and (5) the rationale for an interim analysis.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 Oct 2013
    The sponsor terminated the trial after the 37th event of exacerbation of psychotic symptoms/impending relapse occurred. This was to reduced the overall risk to participants by minimizing exposure to placebo.
    -

    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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