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    Clinical Trial Results:
    Clinical Effectiveness Of The Newer Antipsychotic Compounds Olanzapine, Quetiapine And Aripiprazole In Comparison With Low Dose Conventional Antipsychotics (Haloperidol And Flupentixol) In Patients With Schizophrenia The Neuroleptic Strategy Study - NeSSy

    Summary
    EudraCT number
    		 2009-010966-47
    Trial protocol
    		 DE  
    Global end of trial date
    31 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Feb 2020
    First version publication date
    29 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NeSSy_200901
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01164059
    WHO universal trial number (UTN)
    		 U1111-1112-9727
    Other trial identifiers
    		 DRKS-ID: DRKS00000304
    Sponsors
    Sponsor organisation name
    Universität Bremen
    Sponsor organisation address
    Bibliothekstr. 1, Bremen, Germany, D 28359
    Public contact
    Prof. Dr. Jürgen Timm Secretary : Kai Baumgarte , Kompetenzzentrum für Klinische Studien Bremen, 0049 421218 63780, timm@uni-bremen.de
    Scientific contact
    Prof. Dr. Jürgen Timm Secretary : Kai Baumgarte , Kompetenzzentrum für Klinische Studien Bremen, 0049 421218 63780, timm@uni-bremen.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 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparing newer and conventional drugs with respect to contentment with treatment in 1) patients and 2) psychiatrists; Patient: SF-36 (interviewer version with a time frame of one week); Psychiatrist: CGI.
    Protection of trial subjects
    Monitoring of safety laboratory measures, serum level of study drugs, adverse events, metabolic side effects, vital signs. Intervention in case of clinical relevant developments.
    Background therapy
    		 standard of care for psychiatric patients in Germany
    Evidence for comparator
    		 Comparation of typical representatives of newer antipsychotic compounds Olanzapine, Quetiapine, Aripiprazol with typical conventional antipsychotics Haoperidol, Flupentixol. These representatives were chosen based on practical importance for the therapy of schizophrenia in German hospitals discussed by the leading Germen psychiatries during the planning phase of the study (2008-2009) and agreed on by the international referees.
    Actual start date of recruitment
    08 Apr 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 149
    Worldwide total number of subjects
    149
    EEA total number of subjects
    149
    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)
    149
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrollment: first patient in Apri. 8 2010; last patient out August 22, 2013. Recruitment in Germany.

    Pre-assignment
    Screening details
    		 Screening criteria: New patients presenting schizophrenia at the acting centers. Check for in/out criteria; screened: 2374, not fulfilling in/out criteria: 1863, denying particiption: 362

    Pre-assignment period milestones
    Number of subjects started
    		 149
    Number of subjects completed
    		 149

    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    The study drugs were uniquily capsuled, a neutral parcel with the individual medication for each patient was packed using a random list by a central institute and shipped to the acting centre. The serum level measurement by a special central lab were kept blinded, too. Only in case of danger for the patient an unblinding procedure was used.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 newer antipsychotics
    Arm description
    		 Treatment with an newer antipsychotic namely one of the compounds olanzapine, quetiapine or aripiprazol
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Olanzapine
    Investigational medicinal product code
    EU/1/96/022/029
    Other name
    Zyprexa
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg per capsule, 2 to 4 capsules p.d.

    Investigational medicinal product name
    Quetiapine
    Investigational medicinal product code
    70562.00.00
    Other name
    Seroquel Prolong
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg per capsule, 2 to 4 capsules p.d.

    Investigational medicinal product name
    Aripiprazol
    Investigational medicinal product code
    EU/1/04/276/001-005
    Other name
    Abilify
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg per capsule 2 to 4 capsules p.d.

    Arm title
    		 conventional antipsychotics
    Arm description
    		 therapy with conventional antipsychotics, namely haloperidol or flupentixol
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Haloperidol
    Investigational medicinal product code
    PL 00530/0370
    Other name
    Serenace
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1,5 mg per capsule, 2 to 4 capsules p.d.

    Investigational medicinal product name
    Flupentixol
    Investigational medicinal product code
    PL 0458/0076
    Other name
    Fluanxol, Depixol
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3 mg per capsule, 2 to 4 capsules p.d.

    Number of subjects in period 1
    		newer antipsychotics conventional antipsychotics
    Started
    80
    69
    Completed
    73
    63
    Not completed
    7
    6
         Protocol deviation
    7
    6
    Period 2
    Period 2 title
    main trial
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    The study drugs were uniquily capsuled, a neutral parcel with the individual medication for each patient was packed using a random list by a central institute and shipped to the acting centre. The serum level measurement by a special central lab were kept blinded, too. Only in case of danger for the patient an unblinding procedure was used.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 newer antipsychotics
    Arm description
    		 Treatment with an newer antipsychotic namely one of the compounds olanzapine, quetiapine or aripiprazol
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Olanzapine
    Investigational medicinal product code
    EU/1/96/022/029
    Other name
    Zyprexa
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg per capsule, 2 to 4 capsules p.d.

    Investigational medicinal product name
    Quetiapine
    Investigational medicinal product code
    70562.00.00
    Other name
    Seroquel Prolong
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg per capsule, 2 to 4 capsules p.d.

    Investigational medicinal product name
    Aripiprazol
    Investigational medicinal product code
    EU/1/04/276/001-005
    Other name
    Abilify
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg per capsule 2 to 4 capsules p.d.

    Arm title
    		 conventional antipsychotics
    Arm description
    		 therapy with conventional antipsychotics, namely haloperidol or flupentixol
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Haloperidol
    Investigational medicinal product code
    PL 00530/0370
    Other name
    Serenace
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1,5 mg per capsule, 2 to 4 capsules p.d.

    Investigational medicinal product name
    Flupentixol
    Investigational medicinal product code
    PL 0458/0076
    Other name
    Fluanxol, Depixol
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3 mg per capsule, 2 to 4 capsules p.d.

    Number of subjects in period 2
    		newer antipsychotics conventional antipsychotics
    Started
    73
    63
    Completed
    21
    11
    Not completed
    52
    52
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    6
    9
         Protocol deviation
    45
    43

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    newer antipsychotics
    Reporting group description
    		 Treatment with an newer antipsychotic namely one of the compounds olanzapine, quetiapine or aripiprazol

    Reporting group title
    conventional antipsychotics
    Reporting group description
    		 therapy with conventional antipsychotics, namely haloperidol or flupentixol

    Reporting group values
    		 newer antipsychotics conventional antipsychotics Total
    Number of subjects
    		 80 69 149
    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)
    		 34.53 ( 10.42 ) 34.43 ( 10.65 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 16 44
        Male
    		 45 47 92
        not in FAS
    		 7 6 13
    smoker
    Units: Subjects
        yes
    		 53 37 90
        no
    		 19 24 43
        unknown
    		 1 2 3
        not in FAS
    		 7 6 13
    Duration of illness
    Time since first diagnosis until randomisation
    Units: years
        arithmetic mean (standard deviation)
    		 4.86 ( 5.88 ) 7.11 ( 7.37 ) -
    SF36
    Total score SF36
    Units: scores
        arithmetic mean (standard deviation)
    		 76.92 ( 13.92 ) 76.59 ( 16.83 ) -
    BMI
    body mass index
    Units: score
        arithmetic mean (standard deviation)
    		 26.39 ( 6.13 ) 27.96 ( 7.04 ) -
    CGI-S
    Clinical global impression scale
    Units: Scores
        arithmetic mean (standard deviation)
    		 5.10 ( 0.85 ) 5.06 ( 0.77 ) -
    PANSS
    Positive and negative syndrom scale
    Units: scores
        arithmetic mean (standard deviation)
    		 81.4 ( 22.8 ) 83.6 ( 16.9 ) -
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised patients with at least one drug application

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    136
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.48 ( 10.53 )
    Gender categorical
    Units: Subjects
        Female
    44
        Male
    92
        not in FAS
    0
    smoker
    Units: Subjects
        yes
    90
        no
    43
        unknown
    3
        not in FAS
    0
    Duration of illness
    Time since first diagnosis until randomisation
    Units: years
        arithmetic mean (standard deviation)
    5.90 ( 6.61 )
    SF36
    Total score SF36
    Units: scores
        arithmetic mean (standard deviation)
    76.77 ( 15.34 )
    BMI
    body mass index
    Units: score
        arithmetic mean (standard deviation)
    26.33 ( 6.48 )
    CGI-S
    Clinical global impression scale
    Units: Scores
        arithmetic mean (standard deviation)
    5.08 ( 0.81 )
    PANSS
    Positive and negative syndrom scale
    Units: scores
        arithmetic mean (standard deviation)
    82.42 ( 20.28 )

    End points

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    End points reporting groups
    Reporting group title
    newer antipsychotics
    Reporting group description
    		 Treatment with an newer antipsychotic namely one of the compounds olanzapine, quetiapine or aripiprazol

    Reporting group title
    conventional antipsychotics
    Reporting group description
    		 therapy with conventional antipsychotics, namely haloperidol or flupentixol
    Reporting group title
    newer antipsychotics
    Reporting group description
    		 Treatment with an newer antipsychotic namely one of the compounds olanzapine, quetiapine or aripiprazol

    Reporting group title
    conventional antipsychotics
    Reporting group description
    		 therapy with conventional antipsychotics, namely haloperidol or flupentixol

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised patients with at least one drug application

    Primary: SF36 AUC

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    End point title
    		 SF36 AUC
    End point description
    Area under curve of SF36 values with log-time scale.
    End point type
    Primary
    End point timeframe
    during main period
    End point values
    		 newer antipsychotics conventional antipsychotics
    Number of subjects analysed
    67 [1]
    60 [2]
    Units: Scores
        arithmetic mean (standard deviation)
    85.1 ( 14.7 )
    79.8 ( 17.2 )
    Attachments
    		 SF36 values baseline corrected (%)
    Notes
    [1] - 6 cases of full analysis set not assessable
    [2] - 3 cases of full analysis set not assessable
    Statistical analysis title
    		 SF36 ANCOVA
    Statistical analysis description
    Testing contrast for both groups after ANCOVA with all 5 drugs as factors.
    Comparison groups
    newer antipsychotics v conventional antipsychotics
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0118 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.6
         upper limit
    		 8
    Variability estimate
    Standard deviation
    Dispersion value
    15.4
    Notes
    [3] - A 5% Bonferroni-Holm procedure was applied and p<0.025 is significant.

    Primary: CGI AUC

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    End point title
    		 CGI AUC
    End point description
    Area under curve of CGI values on logtime scale
    End point type
    Primary
    End point timeframe
    during main trial period
    End point values
    		 newer antipsychotics conventional antipsychotics
    Number of subjects analysed
    73
    63
    Units: Score
        arithmetic mean (standard deviation)
    3.26 ( 0.92 )
    3.38 ( 0.88 )
    Attachments
    		 CGI development
    Statistical analysis title
    		 CGI ANCOVA
    Statistical analysis description
    Testing contrast of comparison groups with ANCOVA involving all 5 drugs as factors
    Comparison groups
    newer antipsychotics v conventional antipsychotics
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3701 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 0.08
    Variability estimate
    Standard deviation
    Dispersion value
    0.9
    Notes
    [4] - A 5% Bonferroni-Holm procedure was applied. p>0.025 is not significant (preplanned analysis). Due to deviation from normality a sensitvty analysis with Mann-Whitney-test was conducted. Result: P=0.3037 confirming the non significant result.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    main trial period
    Adverse event reporting additional description
    questionaire at each of 6 visits (week 1,2,4,6,12,24)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Newer compounds
    Reporting group description
    		 -

    Reporting group title
    conventional compounds
    Reporting group description
    		 -

    Serious adverse events
    		 Newer compounds conventional compounds
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 73 (13.70%)
    6 / 63 (9.52%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    suspected drug misuse
    Additional description: death; same patient tried suicide about 2 months ago. She was at home 2 months after last application of study medication.
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    sleepless, angst
    Additional description: increasing angst, sleepless, restiveness
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Iridocyclitis
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    pneumonia; lung embolism
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suizidversuch, Suizidgedanken
         subjects affected / exposed
    2 / 73 (2.74%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    psychotische Decompensation, Exazerbation, emotionaler Einbruch etcerb
    Additional description: combination of SAEs with varying descriptions
         subjects affected / exposed
    7 / 73 (9.59%)
    6 / 63 (9.52%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Newer compounds conventional compounds
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 73 (43.84%)
    24 / 63 (38.10%)
    General disorders and administration site conditions
    General physical condition decreased
         subjects affected / exposed
    5 / 73 (6.85%)
    3 / 63 (4.76%)
         occurrences all number
    5
    3
    Reproductive system and breast disorders
    Libido decreased
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Psychiatric evaluation abnormal
         subjects affected / exposed
    6 / 73 (8.22%)
    3 / 63 (4.76%)
         occurrences all number
    6
    3
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    3 / 73 (4.11%)
    1 / 63 (1.59%)
         occurrences all number
    3
    1
    Nervous system disorders
    Nervous system disorder
         subjects affected / exposed
    18 / 73 (24.66%)
    18 / 63 (28.57%)
         occurrences all number
    18
    18
    Eye disorders
    Visual acuity reduced
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Gastric disorder
         subjects affected / exposed
    6 / 73 (8.22%)
    6 / 63 (9.52%)
         occurrences all number
    6
    6
    Hepatobiliary disorders
    Hepatitis C
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Skin disorder
         subjects affected / exposed
    5 / 73 (6.85%)
    0 / 63 (0.00%)
         occurrences all number
    5
    0
    Renal and urinary disorders
    Renal disorder
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal disorder
         subjects affected / exposed
    0 / 73 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Metabolic disorder
         subjects affected / exposed
    2 / 73 (2.74%)
    2 / 63 (3.17%)
         occurrences all number
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jun 2012
    Update of known adverse reactions in "Fchinformation" of study drugs
    03 Nov 2012
    Update of known adverse reactions in "Fchinformation" of study drugs; expanding inclusion of Patient with less then 1 year but more than 6 months duration of illness
    05 Dec 2012
    Update of known adverse reactions in "Fchinformation" of study drugs; update of manufacturing process of placebo

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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