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    Clinical Trial Results:
    The Bergen Psychosis Project 2

    Summary
    EudraCT number
    		 2010-022307-22
    Trial protocol
    		 NO   AT  
    Global end of trial date
    20 Dec 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    BergenPsychosisProject2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01446328
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Haukeland University Hospital
    Sponsor organisation address
    Jonas Liesvei 65, Bergen, Norway,
    Public contact
    Department of Research, Sandviken, Haukeland University Hospital, Division of Psychiatry, Department of Research, +47 55958400, erij@helse-bergen.no
    Scientific contact
    Department of Research, Sandviken, Haukeland University Hospital, Division of Psychiatry, Department of Research, +47 55958400, erij@helse-bergen.no
    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
    20 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare the clinical effectiveness of amisulpride, aripiprazole, and olanzapine, in patients with schizophrenia and related psychotic disorders, in a head-to-head pragmatic, randomized trial funded independently of the pharmaceutical industry; and , through a translational approach, to link drug-induced changes in symptoms, neurocognitive functioning and side effects, to changes in biological substrates on neurochemical, functional and structural levels. .
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 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
    Norway: 24
    Country: Number of subjects enrolled
    Austria: 120
    Worldwide total number of subjects
    144
    EEA total number of subjects
    144
    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)
    142
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment from mental health hospital wards and outpatient clinics between October 20, 2011 and December 30, 2016. Recruitment in Bergen, Stavanger and Trondheim in Norway, and Innsbruck in Austria.

    Pre-assignment
    Screening details
    		 Egible pastiens were adults (18 years or more of age), with schizophrenia-spectrum disorder (ICD-10 F20-29), and ongoing psychosis. A total of 359 patients assessed for eligibility. 215 patients were excluded (107 did not meet inclusion criteria, 82 declined to participate, and 26 other reasons).

    Pre-assignment period milestones
    Number of subjects started
    		 144
    Number of subjects completed
    		 144

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    According to the pragmatic design aiming to mimick usual clinical practice, only assessors were binded to treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Amisulpride
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Amisulpride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50-1200 mg per day

    Arm title
    		 Aripiprazole
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aripiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5-30 mg per day

    Arm title
    		 Olanzapine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Olanzapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5-20 mg per day

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: According to the pragmatic design aiming to mimick usual clinical practice, only assessors were binded to treatment.
    Number of subjects in period 1
    		Amisulpride Aripiprazole Olanzapine
    Started
    44
    48
    52
    Completed
    44
    48
    52
    Period 2
    Period 2 title
    Overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [2]
    Blinding implementation details
    According to the pragmatic design aiming to mimick usual clinical practice, only assessors were binded to treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Amisulpride
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Amisulpride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50-1200 mg per day

    Arm title
    		 Aripiprazole
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aripiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5-30 mg per day

    Arm title
    		 Olanzapine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Olanzapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5-20 mg per day

    Investigational medicinal product name
    Olanzapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5-20 mg per day

    Notes
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: According to the pragmatic design aiming to mimick usual clinical practice, only assessors were binded to treatment.
    Number of subjects in period 2
    		Amisulpride Aripiprazole Olanzapine
    Started
    44
    48
    52
    Completed
    21
    13
    25
    Not completed
    23
    35
    27
         Lost to follow-up
    23
    35
    27

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 144 144
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 142 142
        From 65-84 years
    		 2 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.7 ( 12.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 51 51
        Male
    		 93 93
    Subject analysis sets

    Subject analysis set title
    Amisulpride
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants allocated to amisulpride

    Subject analysis set title
    Aripiprazole
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants allocated to aripiprazole

    Subject analysis set title
    Olanzapine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants allocated to olanzapine

    Subject analysis sets values
    		 Amisulpride Aripiprazole Olanzapine
    Number of subjects
    44
    48
    52
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    43
    47
    52
        From 65-84 years
    1
    1
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    30.6 ( 11.7 )
    32.1 ( 13.1 )
    32.2 ( 13.3 )
    Gender categorical
    Units: Subjects
        Female
    16
    16
    19
        Male
    28
    32
    33

    End points

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    End points reporting groups
    Reporting group title
    Amisulpride
    Reporting group description
    		 -

    Reporting group title
    Aripiprazole
    Reporting group description
    		 -

    Reporting group title
    Olanzapine
    Reporting group description
    		 -
    Reporting group title
    Amisulpride
    Reporting group description
    		 -

    Reporting group title
    Aripiprazole
    Reporting group description
    		 -

    Reporting group title
    Olanzapine
    Reporting group description
    		 -

    Subject analysis set title
    Amisulpride
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants allocated to amisulpride

    Subject analysis set title
    Aripiprazole
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants allocated to aripiprazole

    Subject analysis set title
    Olanzapine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants allocated to olanzapine

    Primary: PANSS total score

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    End point title
    		 PANSS total score
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Amisulpride Aripiprazole Olanzapine Amisulpride Aripiprazole Olanzapine Amisulpride Aripiprazole Olanzapine
    Number of subjects analysed
    44
    48
    52
    44
    48
    52
    44
    48
    52
    Units: PANSS
        arithmetic mean (standard deviation)
    -32.7 ( 3.1 )
    -21.9 ( 3.9 )
    -23.3 ( 2.9 )
    -32.7 ( 3.1 )
    -21.9 ( 3.9 )
    -23.3 ( 2.9 )
    -32.7 ( 3.1 )
    -21.9 ( 3.9 )
    -23.3 ( 2.9 )
    Statistical analysis title
    		 Primary outcome
    Comparison groups
    Amisulpride v Aripiprazole v Olanzapine
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0-12 months
    Adverse event reporting additional description
    Information about adverse events were systematically collected by use of the UKU-Side Effect Rating Scale, patient-rated version at each assessment point.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Amisulpride
    Reporting group description
    		 Participants allocated amisulpride

    Reporting group title
    Aripiprazole
    Reporting group description
    		 Participants allocated aripiprazole

    Reporting group title
    Olanzapine
    Reporting group description
    		 Participants allocated olanzapine

    Serious adverse events
    		 Amisulpride Aripiprazole Olanzapine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 44 (9.09%)
    10 / 48 (20.83%)
    6 / 52 (11.54%)
         number of deaths (all causes)
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Accident
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somatic admission
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pregnancy
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychosis exacerbation
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Readmission
         subjects affected / exposed
    2 / 44 (4.55%)
    7 / 48 (14.58%)
    6 / 52 (11.54%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prolonged hospitalization
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Amisulpride Aripiprazole Olanzapine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 44 (38.64%)
    9 / 48 (18.75%)
    13 / 52 (25.00%)
    Nervous system disorders
    Extrapyramidal disorder
         subjects affected / exposed
    5 / 44 (11.36%)
    5 / 48 (10.42%)
    6 / 52 (11.54%)
         occurrences all number
    5
    5
    6
    Reproductive system and breast disorders
    Sexual dysfunction
         subjects affected / exposed
    4 / 44 (9.09%)
    4 / 48 (8.33%)
    2 / 52 (3.85%)
         occurrences all number
    4
    4
    2
    Endocrine disorders
    Hyperprolactinaemia
         subjects affected / exposed
    14 / 44 (31.82%)
    3 / 48 (6.25%)
    10 / 52 (19.23%)
         occurrences all number
    14
    3
    10

    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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