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    Clinical Trial Results:
    Aripiprazol Addon – Treatment to improve cognitive function in bipolar disorder (Cognitive impairment in bipolar disorder treated with aripiprazole)

    Summary
    EudraCT number
    		 2009-017581-22
    Trial protocol
    		 DE  
    Global end of trial date
    31 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2021
    First version publication date
    18 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20091003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin , Germany, 10117
    Public contact
    PD Dr. med. Mazda Adli, Charité - Universitätsmedizin Berlin, +49 30 450 517146, mazda.adli@charite.de
    Scientific contact
    PD Dr. med. Mazda Adli, Charité - Universitätsmedizin Berlin, +49 30 450 517146, mazda.adli@charite.de
    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
    31 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To improve baseline cognitive functioning regarding verbal memory by 12 weeks aripiprazole add-on therapy in bipolar, euthymic patients.
    Protection of trial subjects
    No SAE and no SUSAR occurred. An impairment of the safety of the subjects in the sense of a risk-benefit analysis cannot be assumed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jan 2011
    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
    Germany: 62
    Worldwide total number of subjects
    62
    EEA total number of subjects
    62
    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)
    6
    Adults (18-64 years)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at study centers Charité-UnversitätsmedizinKlinik für Psychiatrie und Psychotherapie in Germany, between 27/01/2011 and 28/02/2013.

    Pre-assignment
    Screening details
    		 A total of 44 subjects entered the screening period according the inclusion criteria for Bipolar disorder (Bipolar I+II patients , Euthymic interval for at least 6 months,HAMD-21 < 10 and YMRS < 12, subjectively reported neurocognitive impairment, assessed by FEDA. N= 3 sreening failures N= 21 healthy control group match to the patient group

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aripiprazol Group
    Arm description
    		 Subjects received up to 15 mg of Aripiprazol
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aripiprazol
    Investigational medicinal product code
    N 05 AX 12
    Other name
    Abilify
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    daily, duration 12 weeks, three dosage units are available for this study (5mg, 10mg, 15mg) depending on weight

    Arm title
    		 Control group
    Arm description
    		 21 healthy control subjects were included in the study. The control group was matched to the patient group in age and sex in parallel .
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Aripiprazol Group Control group
    Started
    41
    21
    Completed
    21
    21
    Not completed
    20
    0
         Consent withdrawn by subject
    9
    -
         Adverse event, non-fatal
    9
    -
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aripiprazol Group
    Reporting group description
    		 Subjects received up to 15 mg of Aripiprazol

    Reporting group title
    Control group
    Reporting group description
    		 21 healthy control subjects were included in the study. The control group was matched to the patient group in age and sex in parallel .

    Reporting group values
    		 Aripiprazol Group Control group Total
    Number of subjects
    		 41 21 62
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 6 0 6
        Adults (18-64 years)
    		 35 21 56
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 26.2 (12 to 52) 26.2 (18 to 60) -
    Gender categorical
    Units: Subjects
        Female
    		 22 11 33
        Male
    		 19 10 29
    Status
    Sociodemographic Data
    Units: Subjects
        single
    		 13 6 19
        married living together
    		 13 13 26
        married living separated
    		 2 0 2
        living together in partnership
    		 2 1 3
        divorced
    		 3 1 4
        n/a
    		 8 0 8
    High school degree
    Units: Subjects
        Highschool
    		 2 0 2
        O-Level
    		 7 4 11
        A-Level
    		 25 17 42
        n/a
    		 7 0 7
    Highest professional qualification
    Units: Subjects
        Apprenticeship
    		 12 3 15
        Technical school
    		 3 2 5
        College / University
    		 17 12 29
        Not yet finished
    		 1 0 1
        No qualification
    		 1 4 5
        n/a
    		 7 0 7
    Current professional situation
    Units: Subjects
        employed, fulltime
    		 10 13 23
        employed, part-time
    		 5 3 8
        Housewife /-man, not employed
    		 3 0 3
        Protected employment
    		 1 0 1
        unemployed
    		 3 1 4
        Occupational/disability pension, Pension procedure
    		 7 0 7
        Retirement pension/ pension
    		 1 0 1
        Pupil / student
    		 2 3 5
        Training/ Apprenticeship
    		 1 1 2
        n/a
    		 8 0 8
    Netto income / month in Euro
    Units: Subjects
        less than 500
    		 7 2 9
        500-1000
    		 6 3 9
        1000-2000
    		 11 5 16
        2000-3000
    		 5 7 12
        3000-5000
    		 2 4 6
        more than 5000
    		 1 0 1
        n/a
    		 9 0 9
    Number of episodes: total
    Units: Scale
        arithmetic mean (standard deviation)
    		 12.4 ( 8.56 ) 0 ( 0 ) -
    Number of episodes: depressive
    Units: Scale
        arithmetic mean (standard deviation)
    		 7.0 ( 5.29 ) 0 ( 0 ) -
    Number of episodes: manic
    Units: Scale
        arithmetic mean (standard deviation)
    		 2.9 ( 2.33 ) 0 ( 0 ) -
    Number of episodes: mixed
    Units: Scale
        arithmetic mean (standard deviation)
    		 1.2 ( 2.04 ) 0 ( 0 ) -
    Number of episodes: sub depressive
    Units: Scale
        arithmetic mean (standard deviation)
    		 0.1 ( 0.49 ) 0 ( 0 ) -
    Number of episodes: hypomanic
    Units: Scale
        arithmetic mean (standard deviation)
    		 3.5 ( 4.23 ) 0 ( 0 ) -
    HAMD
    Hamilton rating scale for depression
    Units: Score
        arithmetic mean (standard deviation)
    		 3.7 ( 3.42 ) 0 ( 0 ) -
    YMRS
    Young Mania Rating Scale
    Units: Score
        arithmetic mean (standard deviation)
    		 0.9 ( 1.72 ) 0 ( 0 ) -
    FAST total score
    Functional Arm Scale for Throwers
    Units: Score
        arithmetic mean (standard deviation)
    		 22.30 ( 12.32 ) 0 ( 0 ) -
    CSS total score
    calibrated severity scores
    Units: Score
        arithmetic mean (standard deviation)
    		 20.00 ( 16.38 ) 0 ( 0 ) -

    End points

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    End points reporting groups
    Reporting group title
    Aripiprazol Group
    Reporting group description
    		 Subjects received up to 15 mg of Aripiprazol

    Reporting group title
    Control group
    Reporting group description
    		 21 healthy control subjects were included in the study. The control group was matched to the patient group in age and sex in parallel .

    Primary: Change in verbal memory function measured with California Verbal Learning Test

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    End point title
    		 Change in verbal memory function measured with California Verbal Learning Test
    End point description
    Regarding to the primary hypothesis, there were no significant differences between patient and control group in declarative verbal memory on the scales Absolute recall performance after temporal delay, loss after interference as well as loss after time delay (See attachment table 14 and figure 4 for more details ). Even after 12 weeks of treatment with aripiprazole, no improvement was observed with regard to verbal memory.
    End point type
    Primary
    End point timeframe
    12 Weeks
    End point values
    		 Aripiprazol Group Control group
    Number of subjects analysed
    41
    21
    Units: Score
    number (not applicable)
        Total score
    52.9
    54.7
        Absolute recall performance after temporal delay
    12.3
    10.7
        Loss after interference
    1.9
    4.8
        Loss after time delay
    1.7
    2.5
    Attachments
    		 Table 14 and Figure 4
    Statistical analysis title
    		 Comparison of the Auditory Verbal Learning Test
    Statistical analysis description
    The collected data were analyzed according to the intention-to-treat principle. The statistical analyses were calculated by SPSS. Group differences were calculated by using T-tests for independent samples and analyses of variance.
    Comparison groups
    Aripiprazol Group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.2
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: the psychosocial functioning level: FAST

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    End point title
    		 the psychosocial functioning level: FAST
    End point description
    The psychosocial functioning level of the patient group differs significantly from the healthy control group on all scales (cognitive and professional functioning, independence, financial affairs, interpersonal relationships, spare time). For further detailed results see attachment, table 8 and figur 1.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Aripiprazol Group Control group
    Number of subjects analysed
    41
    21
    Units: Score
    number (not applicable)
        Total score
    22.3
    5.7
        Scale_cognitive function
    5.6
    2.2
        Scale_professionial function
    6.4
    0.7
        Scale_independence
    2.1
    0.6
        Scale_financial affairs
    1.2
    0.3
        Scale_interpersonal relationships
    5.7
    1.3
        Scale_spare time
    2.6
    0.5
    Attachments
    		 Tables and Figures
    No statistical analyses for this end point

    Secondary: the neuropsychological examination: FEDA

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    End point title
    		 the neuropsychological examination: FEDA
    End point description
    The subjective perception of attention and memory performance measured by FEDA shows a difference between the patient and control groups. The group difference is significant on all three scales (cognition, fatigue, motivation)
    End point type
    Secondary
    End point timeframe
    12 Weeks
    End point values
    		 Aripiprazol Group Control group
    Number of subjects analysed
    41
    21
    Units: Score
    number (not applicable)
        Total score
    96.6
    122.6
        Scale cognition
    45.9
    57.3
        Scale fatigue
    28.4
    36.9
        Scale motivation
    20.1
    27.8
    Attachments
    		 Table 9 and Figure 2
    Statistical analysis title
    		 Comparison of mean values of the scales of the FED
    Statistical analysis description
    The collected data were analyzed according to the intention-to-treat principle. The statistical analyses were calculated by SPSS. Group differences were calculated by using T-tests for independent samples and analyses of variance.
    Comparison groups
    Aripiprazol Group v Control group
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Alsterdorfer Face Test

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    End point title
    		 Alsterdorfer Face Test
    End point description
    There was no significant difference between patient and control groups for direct retrieval, delayed retrieval after direct retrieval, or no direct retrieval in face recognition (see Table 10, Figure 3 for more informations).
    End point type
    Secondary
    End point timeframe
    12 Weeks
    End point values
    		 Aripiprazol Group Control group
    Number of subjects analysed
    41
    21
    Units: Score
    number (not applicable)
        Direct recall
    67.9
    67.6
        Delayed recall after direct recall
    56.8
    59.3
        Delayed recall without direct recall
    48.9
    47.4
    Attachments
    		 Table and Figure
    No statistical analyses for this end point

    Secondary: Regensburger Word Fluency Test

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    End point title
    		 Regensburger Word Fluency Test
    End point description
    Mean comparisons in terms of word fluency, assessed with the Regensburg Word Fluency Test, also show no group difference (see Table 12 for more informations)
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Aripiprazol Group Control group
    Number of subjects analysed
    41
    21
    Units: Score
    number (not applicable)
        Subtest 1
    18.8
    20.7
        Subtest 2
    19.3
    20.3
    Attachments
    		 Untitled (Filename: Table 12.pdf)
    No statistical analyses for this end point

    Secondary: Wechsler Adult Intelligence Scale

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    End point title
    		 Wechsler Adult Intelligence Scale
    End point description
    Mean analyses of the Wechsler Intelligence Test show that the patient and control groups differ significantly. The patient group is superior to the comparison population in the subscales Number Reasoning and Number Symbol Test (for more informations see Table 13).
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Aripiprazol Group Control group
    Number of subjects analysed
    41
    21
    Units: Score
    number (not applicable)
        Matrix reasoning
    10.9
    12.1
        Digit span
    10.8
    9.3
        Letter-Number Sequencing
    9.1
    11.7
    Attachments
    		 Untitled (Filename: Table 13.pdf)
    No statistical analyses for this end point

    Secondary: Tests for Attentional Performance (TAP)

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    End point title
    		 Tests for Attentional Performance (TAP)
    End point description
    TAP shows no significant difference between patient and control group (for more informations see Table 15)
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Aripiprazol Group Control group
    Number of subjects analysed
    41
    21
    Units: Score
    number (not applicable)
        Working memory
    619.9
    527.7
        Alertness without warning signal
    274.1
    271.1
        Alertness with warning signal
    271.1
    261.3
        Flexibility total
    791.6
    791.1
    Attachments
    		 Untitled (Filename: Table 15.pdf)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 Weeks
    Adverse event reporting additional description
    Patients discontinued the study due to ADR (1x drowsiness, 2x sleep disturbance/early awakening, 1x inner restlessness, 1x manic relapse, 1x depressive relapse, 2x visual disturbances, 1x headache and dizziness).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Aripiprazol Group
    Reporting group description
    		 -

    Serious adverse events
    		 Aripiprazol Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Aripiprazol Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 41 (21.95%)
    Psychiatric disorders
    ADR
    Additional description: Adverse Drug Reaction
         subjects affected / exposed
    9 / 41 (21.95%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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