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    Clinical Trial Results:
    Effect of atypical antipsychotics on gene expression in soft tissues of healthy subjects. A placebo controlled randomised pilot study.

    Summary
    EudraCT number
    		 2009-011097-15
    Trial protocol
    		 AT  
    Global end of trial date
    04 Mar 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OLA_ZIPRA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Wien, Austria, 1090
    Public contact
    Office of the Dep. of Clinical Pharmacology, Department of Clinical Pharmacology, +431 4040029810, klin-pharmakologie@meduniwien.ac.at
    Scientific contact
    Office of the Dep. of Clinical Pharmacology, Department of Clinical Pharmacology, +431 4040029810, klin-pharmakologie@meduniwien.ac.at
    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
    04 Mar 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Mar 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Differences in the soft tissue gene expression profile after administration of olanzapine or ziprasidone after single and multiple dose administration.
    Protection of trial subjects
    During the period of study days subjects will be observed by a physician or an experienced nurse.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jul 2010
    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
    Austria: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    17
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment by using data base of the Clinical Pharmacology

    Pre-assignment
    Screening details
    		 Information of subject, checking of In -and exclusion criteria, investigations according to study protocol

    Pre-assignment period milestones
    Number of subjects started
    		 17
    Number of subjects completed

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    In the morning of the first study day, volunteers were allocated to groups A, B or C based on a block randomization schedule. Medication and placebo was labeled and blinded at the local pharmacy.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Group A: Administration of ZYPREXA® containing 10 mg of olanzapine once daily and placebo once daily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Zyprexa
    Investigational medicinal product code
    N05AH03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administration of ZYPREXA® containing 10 mg of olanzapine once daily and placebo once daily

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    •Group A: Administration of ZYPREXA® containing 10 mg of olanzapine once daily and placebo once daily

    Arm title
    		 Group B
    Arm description
    		 Group B: Administration of ZELDOX® containing 40 mg of ziprasidone twice daily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Zeldox
    Investigational medicinal product code
    N05AE04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Group B: Administration of ZELDOX® containing 40 mg of ziprasidone twice daily

    Arm title
    		 Group C
    Arm description
    		 Group C: Administration of placebo twice daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Group C: Administration of placebo twice daily

    Number of subjects in period 1
    		Group A Group B Group C
    Started
    7
    6
    4
    Completed
    6
    6
    4
    Not completed
    1
    0
    0
         Physician decision
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Group A: Administration of ZYPREXA® containing 10 mg of olanzapine once daily and placebo once daily

    Reporting group title
    Group B
    Reporting group description
    		 Group B: Administration of ZELDOX® containing 40 mg of ziprasidone twice daily

    Reporting group title
    Group C
    Reporting group description
    		 Group C: Administration of placebo twice daily

    Reporting group values
    		 Group A Group B Group C Total
    Number of subjects
    		 7 6 4 17
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 7 6 4 17
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Gender categorical
    Male subjects
    Units: Subjects
        Female
    		 0 0 0 0
        Male
    		 7 6 4 17

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Group A: Administration of ZYPREXA® containing 10 mg of olanzapine once daily and placebo once daily

    Reporting group title
    Group B
    Reporting group description
    		 Group B: Administration of ZELDOX® containing 40 mg of ziprasidone twice daily

    Reporting group title
    Group C
    Reporting group description
    		 Group C: Administration of placebo twice daily

    Primary: Differences in the soft tissue gene expression profile after administration of olanzapine or ziprasidone after single and multiple dose administration.

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    End point title
    		 Differences in the soft tissue gene expression profile after administration of olanzapine or ziprasidone after single and multiple dose administration.
    End point description
    End point type
    Primary
    End point timeframe
    5/8 hours after medication
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    6
    6
    4
    Units: Other
    6
    6
    4
    Statistical analysis title
    		 End point statistic
    Comparison groups
    Group A v Group B v Group C
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    19.07.2010-04.03.2011
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Adverse Events
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse Events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse Events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 17 (82.35%)
    Investigations
    Asat
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vascular disorders
    Hematoma at biopsy side
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Cephalgia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Orthostatic collapse
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Akathisia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    5
    Photophobia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    General disorders and administration site conditions
    Tiredness
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    14
    Increased appetite
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Eye disorders
    Tired eyes
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Inability to open eyes
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    muscle soreness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pain left thigh
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    1 / 17 (5.88%)
         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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