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    Clinical Trial Results:
    A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients with Schizophrenia

    Summary
    EudraCT number
    2012-003806-28
    Trial protocol
    LV  
    Global end of trial date
    17 Feb 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    31-12-297
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01683058
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Sponsor organisation address
    2440 Research Boulevard, Rockville, Maryland, United States, 20850
    Public contact
    Timothy Peters-Strickland, Otsuka Pharmaceutical Development & Commercialization, +1 609-249-6559, Tim.Peters-Strickland@otsuka-us.com
    Scientific contact
    Timothy Peters-Strickland, Otsuka Pharmaceutical Development & Commercialization, +1 609-249-6559, Tim.Peters-Strickland@otsuka-us.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
    10 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this open-label trial was to evaluate the safety and tolerability of aripiprazole intramuscular (IM) depot administered for 26 weeks to participants with schizophrenia.
    Protection of trial subjects
    The trial was conducted in compliance with the protocol, International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Consolidated Guideline, and the applicable local laws and regulatory requirements of the countries in which the trial was conducted, copies of the protocol, amendments, and informed consent form (ICF) were reviewed and approved by the governing institutional review board (IRB) or independent ethics committee (IEC) for each investigational site or country, as appropriate, prior to trial start or prior to implementation of the amendment at that site or country.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Jan 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 68
    Country: Number of subjects enrolled
    Croatia: 5
    Country: Number of subjects enrolled
    Latvia: 1
    Worldwide total number of subjects
    74
    EEA total number of subjects
    6
    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)
    74
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A multicenter, open-label, single-arm rollover trial designed to demonstrate the safety of aripiprazole intramuscular (IM) depot [400 or 300 milligrams (mg)] for the acute treatment of participants with schizophrenia, who met completion criteria in the registration trial 2012-003805-86. 74 participants were enrolled in this trial.

    Pre-assignment
    Screening details
    Participants entered this trial after completing the Week 12/Early Termination (ET) visit of trial 2012-003805-86 as it served as the Baseline evaluations for this trial.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This was an open-label trial.

    Arms
    Arm title
    Aripiprazole IM Depot 400/300 mg
    Arm description
    All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Aripiprazole
    Investigational medicinal product code
    OPC-14597, Lu AF41155
    Other name
    Abilify
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All participants received aripiprazole IM depot 400 mg/ 300 mg every 4 weeks for 24 weeks.

    Number of subjects in period 1
    Aripiprazole IM Depot 400/300 mg
    Started
    74
    Completed
    45
    Not completed
    29
         Met withdrawal criteria
    5
         Adverse event
    6
         Lack of efficacy
    2
         Consent withdrawn by subject
    7
         Lost to follow-up
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aripiprazole IM Depot 400/300 mg
    Reporting group description
    All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for 24 weeks.

    Reporting group values
    Aripiprazole IM Depot 400/300 mg Total
    Number of subjects
    74 74
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    74 74
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43 ± 11.7 -
    Gender categorical
    Units: Subjects
        Female
    18 18
        Male
    56 56

    End points

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    End points reporting groups
    Reporting group title
    Aripiprazole IM Depot 400/300 mg
    Reporting group description
    All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for 24 weeks.

    Primary: Percentage of participants reporting treatment emergent adverse events (TEAEs)

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    End point title
    Percentage of participants reporting treatment emergent adverse events (TEAEs) [1]
    End point description
    A TEAE was defined as an AE that began after the first injection or was continuous from Baseline for serious AEs, drug-related AEs and AEs resulting in death were also reported. In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for Percentage of participants reporting treatment emergent adverse events (TEAEs), severe TEAEs, discontinued investigational medicinal product (IMP) due to AEs, serious TEAEs and outcome of death
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: percentage of participants
    number (not applicable)
        Participants with TEAEs
    66.2
        Participants with serious TEAEs
    6.8
        Participants with severe TEAEs
    6.8
        Participants discontinued IMP due to AEs
    8.1
        Deaths
    0
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in suicidal ideation intensity total score by the Columbia Suicide Severity Rating Scale (C-SSRS)

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    End point title
    Mean change from Baseline in suicidal ideation intensity total score by the Columbia Suicide Severity Rating Scale (C-SSRS)
    End point description
    Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die, active suicidal thought, active suicidal thought with method, active suicidal thought with intent, active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 4 (N= 69)
    -0.1 ± 2.3
        Week 8 (N= 61)
    -0.1 ± 2.2
        Week 12 (N= 57)
    -0.3 ± 2
        Week 16 (N= 52)
    0.7 ± 4.7
        Week 20 (N= 44)
    0.3 ± 2
        Week 24 (N= 45)
    0 ± 0
        Last Visit (N= 71)
    0.6 ± 4.2
    No statistical analyses for this end point

    Secondary: Mean change from Baseline by Week by Extrapyramidal Symptoms (EPS) evaluated using the Simpson-Angus Scale (SAS)

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    End point title
    Mean change from Baseline by Week by Extrapyramidal Symptoms (EPS) evaluated using the Simpson-Angus Scale (SAS)
    End point description
    The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    72
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 12 (N= 66)
    0.19 ± 1.51
        Week 24 (N= 70)
    0.04 ± 1.62
    No statistical analyses for this end point

    Secondary: Mean change from Baseline by Week by EPS evaluated using the Abnormal Involuntary Movement Scale (AIMS)

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    End point title
    Mean change from Baseline by Week by EPS evaluated using the Abnormal Involuntary Movement Scale (AIMS)
    End point description
    EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    73
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 12 (N= 65)
    -0.06 ± 0.81
        Week 24 (N= 70)
    0.07 ± 1.28
    No statistical analyses for this end point

    Secondary: Mean change from Baseline by Week by EPS evaluated using Barnes Akathisia Rating Scale (BARS)

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    End point title
    Mean change from Baseline by Week by EPS evaluated using Barnes Akathisia Rating Scale (BARS)
    End point description
    The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Participants were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    73
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 12 (N= 65)
    0.19 ± 0.73
        Week 24 (N= 70)
    0.14 ± 0.91
    No statistical analyses for this end point

    Secondary: Mean change in body temperature from Baseline in all participants.

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    End point title
    Mean change in body temperature from Baseline in all participants.
    End point description
    The body temperature, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: °C
    arithmetic mean (standard deviation)
        Week 4 (N= 69)
    0.1 ± 0.4
        Week 8 (N= 61)
    0 ± 0.4
        Week 12 (N= 58)
    0 ± 0.4
        Week 16 (N= 53)
    0 ± 0.3
        Week 20 (N= 44)
    0.1 ± 0.4
        Week 24 (N= 45)
    0.1 ± 0.4
        Last visit (N= 72)
    0 ± 0.4
    No statistical analyses for this end point

    Secondary: Mean change in supine heart rate from Baseline in all participants.

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    End point title
    Mean change in supine heart rate from Baseline in all participants.
    End point description
    The heart rate supine, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: beats per minute
    arithmetic mean (standard deviation)
        Week 4 (N= 69)
    3.8 ± 10.9
        Week 8 (N= 61)
    2.3 ± 11.2
        Week 12 (N= 58)
    1.3 ± 10.8
        Week 16 (N= 53)
    4.7 ± 12
        Week 20 (N= 44)
    3.6 ± 9.8
        Week 24 (N= 45)
    1.7 ± 12.7
        Last visit (N= 72)
    3.4 ± 12.1
    No statistical analyses for this end point

    Secondary: Mean change in supine systolic blood pressure (BP) from Baseline in all participants.

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    End point title
    Mean change in supine systolic blood pressure (BP) from Baseline in all participants.
    End point description
    The systolic supine BP, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: mmHg
    arithmetic mean (standard deviation)
        Week 4 (N= 69)
    1.9 ± 12.8
        Week 8 (N= 61)
    1.3 ± 12.2
        Week 12 (N= 58)
    -0.2 ± 12.4
        Week 16 (N= 53)
    2 ± 12.4
        Week 20 (N= 44)
    4.8 ± 12.8
        Week 24 (N= 45)
    0.7 ± 11.3
        Last visit (N= 72)
    0.4 ± 13.1
    No statistical analyses for this end point

    Secondary: Mean change in supine diastolic BP from Baseline in all participants.

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    End point title
    Mean change in supine diastolic BP from Baseline in all participants.
    End point description
    The diastolic supine BP, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: mmHg
    arithmetic mean (standard deviation)
        Week 4 (N= 69)
    0.1 ± 8.6
        Week 8 (N= 61)
    -1.3 ± 8.1
        Week 12 (N= 58)
    -0.9 ± 7.7
        Week 16 (N= 53)
    0.3 ± 8.6
        Week 20 (N= 44)
    0 ± 9.6
        Week 24 (N= 45)
    0.4 ± 9.7
        Last visit (N= 72)
    0.5 ± 9.9
    No statistical analyses for this end point

    Secondary: Mean change in sitting heart rate from Baseline in all participants.

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    End point title
    Mean change in sitting heart rate from Baseline in all participants.
    End point description
    The heart rate sitting, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: beats per minute
    arithmetic mean (standard deviation)
        Week 4 (N= 69)
    1.2 ± 9.1
        Week 8 (N= 61)
    1.4 ± 10.1
        Week 12 (N= 58)
    -1.1 ± 10.8
        Week 16 (N= 53)
    4.3 ± 12
        Week 20 (N= 44)
    3.3 ± 10.1
        Week 24 (N= 45)
    0.6 ± 13.6
        Last visit (N= 72)
    1.9 ± 13
    No statistical analyses for this end point

    Secondary: Mean change in sitting systolic BP from Baseline in all participants.

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    End point title
    Mean change in sitting systolic BP from Baseline in all participants.
    End point description
    The systolic sitting BP, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: mmHg
    arithmetic mean (standard deviation)
        Week 4 (N= 69)
    -0.1 ± 13
        Week 8 (N= 61)
    -0.3 ± 11.3
        Week 12 (N= 58)
    -0.7 ± 11.3
        Week 16 (N= 53)
    1.6 ± 12.1
        Week 20 (N= 44)
    1 ± 11.5
        Week 24 (N= 45)
    -0.4 ± 12.5
        Last visit (N= 72)
    -0.7 ± 13.4
    No statistical analyses for this end point

    Secondary: Mean change in sitting diastolic BP from Baseline in all participants.

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    End point title
    Mean change in sitting diastolic BP from Baseline in all participants.
    End point description
    The diastolic sitting BP, which is a vital sign parameter was one of the parameters to measure the safety and tolerability of individual participants. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: mmHg
    arithmetic mean (standard deviation)
        Week 4 (N= 69)
    -0.9 ± 9.7
        Week 8 (N= 61)
    -1.7 ± 9.4
        Week 12 (N= 58)
    -0.2 ± 7.9
        Week 16 (N= 53)
    0.8 ± 7.8
        Week 20 (N= 44)
    -0.2 ± 10
        Week 24 (N= 45)
    0.4 ± 9.8
        Last visit (N= 72)
    1.4 ± 10
    No statistical analyses for this end point

    Secondary: Mean change in ventricular rate from Baseline in all participants.

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    End point title
    Mean change in ventricular rate from Baseline in all participants.
    End point description
    The measurement ventricular rate is an ECG parameter which was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: beats per minute
    arithmetic mean (standard deviation)
        Week 12 (N= 56)
    -1.5 ± 12
        Week 24 (N= 43)
    -1.1 ± 12.3
        Last visit (N= 70)
    -0.1 ± 13.7
    No statistical analyses for this end point

    Secondary: Mean change in PR interval from Baseline in all participants.

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    End point title
    Mean change in PR interval from Baseline in all participants.
    End point description
    The measurement PR interval is an ECG parameter was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: msec
    arithmetic mean (standard deviation)
        Week 12 (N= 56)
    3.5 ± 11.1
        Week 24 (N= 43)
    0.5 ± 12.5
        Last visit (N= 70)
    0.9 ± 11.6
    No statistical analyses for this end point

    Secondary: Mean change in RR interval from Baseline in all participants.

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    End point title
    Mean change in RR interval from Baseline in all participants.
    End point description
    The measurement RR interval is an ECG parameter which was one of the primary parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: msec
    arithmetic mean (standard deviation)
        Week 12 (N= 56)
    23.7 ± 140.9
        Week 24 (N= 43)
    23.3 ± 152.2
        Last visit (N= 70)
    8 ± 158.4
    No statistical analyses for this end point

    Secondary: Mean change in QRS interval from Baseline in all participants.

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    End point title
    Mean change in QRS interval from Baseline in all participants.
    End point description
    The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 12 (N= 56)
    -0.1 ± 5
        Week 24 (N= 43)
    0.4 ± 5.3
        Last visit (N= 70)
    0 ± 5.7
    No statistical analyses for this end point

    Secondary: Mean change in QT interval from Baseline in all participants.

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    End point title
    Mean change in QT interval from Baseline in all participants.
    End point description
    The measurement QT interval is an ECG parameter which was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: msec
    arithmetic mean (standard deviation)
        Week 12 (N= 56)
    3.1 ± 21.5
        Week 24 (N= 43)
    1.5 ± 24.9
        Last visit (N= 70)
    1 ± 25.7
    No statistical analyses for this end point

    Secondary: Mean change in QTcB interval from Baseline in all participants.

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    End point title
    Mean change in QTcB interval from Baseline in all participants.
    End point description
    The measurement QTcB interval is an ECG parameter which was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: msec
    arithmetic mean (standard deviation)
        Week 12 (N= 56)
    -1.6 ± 20.2
        Week 24 (N= 43)
    -2.4 ± 19.4
        Last visit (N= 70)
    0.3 ± 19
    No statistical analyses for this end point

    Secondary: Mean change in QTcF interval from Baseline in all participants.

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    End point title
    Mean change in QTcF interval from Baseline in all participants.
    End point description
    The measurement QTcF interval is an ECG parameter which was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: msec
    arithmetic mean (standard deviation)
        Week 12 (N= 56)
    -0.2 ± 13.9
        Week 24 (N= 43)
    -1.3 ± 14
        Last visit (N= 70)
    0.3 ± 12.9
    No statistical analyses for this end point

    Secondary: Mean change in QTcN interval from Baseline in all participants.

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    End point title
    Mean change in QTcN interval from Baseline in all participants.
    End point description
    The measurement QTcN interval is an ECG parameter which was one of the parameters to measure the safety and tolerability of individual participants. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: msec
    arithmetic mean (standard deviation)
        Week 12 (N= 56)
    -0.5 ± 14.7
        Week 24 (N= 43)
    -1.7 ± 14.3
        Last visit (N= 70)
    0.3 ± 13.4
    No statistical analyses for this end point

    Secondary: Mean change in clinically relevant body weight changes from Baseline in all participants.

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    End point title
    Mean change in clinically relevant body weight changes from Baseline in all participants.
    End point description
    Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: kilogram(s)
    arithmetic mean (standard deviation)
        Week 12 (N= 57)
    -0.1 ± 4.5
        Week 24 (N= 44)
    1.3 ± 6
        Last visit (N= 71)
    0.5 ± 5.8
    No statistical analyses for this end point

    Secondary: Mean change in clinically relevant body mass index from Baseline in all participants.

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    End point title
    Mean change in clinically relevant body mass index from Baseline in all participants.
    End point description
    Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: Kg/m2
    arithmetic mean (standard deviation)
        Week 12 (N= 57)
    0 ± 1.5
        Week 24 (N= 44)
    0.5 ± 2
        Last visit (N= 71)
    0.2 ± 1.9
    No statistical analyses for this end point

    Secondary: Mean change in clinically relevant waist circumference from Baseline in all participants.

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    End point title
    Mean change in clinically relevant waist circumference from Baseline in all participants.
    End point description
    Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). Only Week 24 and last visit data was included. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: centimetre
    arithmetic mean (standard deviation)
        Week 24 (N= 44)
    1.6 ± 6.6
        Last visit (N= 64)
    1.3 ± 6
    No statistical analyses for this end point

    Secondary: Number of participants with clinically relevant laboratory values.

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    End point title
    Number of participants with clinically relevant laboratory values.
    End point description
    The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). There were no clinically relevant findings with regard to laboratory values reported in this study.
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Number of participants with clinically relevant physical examination.

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    End point title
    Number of participants with clinically relevant physical examination.
    End point description
    The physical examination evaluation was one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). None of the abnormalities or findings were noted during physical examination were considered clinically relevant.
    End point type
    Secondary
    End point timeframe
    Baseline to last visit
    End point values
    Aripiprazole IM Depot 400/300 mg
    Number of subjects analysed
    74
    Units: participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were recorded from the time the ICF was signed until follow-up for safety 14 (±2) days after the last trial visit.
    Adverse event reporting additional description
    A SAE was any untoward medical occurrence that results in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. An AE was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Aripiprazole IM depot 400/300 mg
    Reporting group description
    All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.

    Serious adverse events
    Aripiprazole IM depot 400/300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 74 (6.76%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 74 (2.70%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Schizophrenia
         subjects affected / exposed
    2 / 74 (2.70%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Aripiprazole IM depot 400/300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 74 (54.05%)
    Investigations
    Weight decreased
         subjects affected / exposed
    6 / 74 (8.11%)
         occurrences all number
    6
    Weight increased
         subjects affected / exposed
    22 / 74 (29.73%)
         occurrences all number
    23
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    9 / 74 (12.16%)
         occurrences all number
    10
    Headache
         subjects affected / exposed
    6 / 74 (8.11%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    4 / 74 (5.41%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Sep 2012
    The changes in this amendment were made to reflect the updates to Protocol 31-12-291 (Trial 2012-003805-86) which eliminated an Interim Analysis. This change required trial 2012-003806-28 remove references to participants who were discontinued from Trial 2012-003805-86 due to a positive interim analysis. General revisions to the protocol were; added Lundbeck Protocol Number Lu AF41155 to cover page and synopsis and made minor formatting corrections.
    12 Oct 2012
    The change in this amendment was made to reflect the correction to needle gauge based on Body Mass Index (BMI). General revisions were made to this protocol such as; Deleted all reference to needle: 21 gauge, 1.5 inch for BMI ≤28 kg/m2 participants in the active treatment phase of Trial 2012-003805-86 who were discontinued from that trial due to a positive interim analysis (IA), changed text to needle: 22 gauge, 1.5 inch for BMI ≤28 and minor formatting corrections.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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