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    Clinical Trial Results:
    TAILOR - a randomized clinical trial: Tapered discontinuation versus maintenance therapy of antipsychotic medication in patients with newly diagnosed schizophrenia or schizophreniform psychosis in remission of psychotic symptoms

    Summary
    EudraCT number
    		 2016-000565-23
    Trial protocol
    		 DK  
    Global end of trial date
    19 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 May 2021
    First version publication date
    28 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2016-867
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Copenhagen Research Center for Mental Health, CORE
    Sponsor organisation address
    Gentoftehospitalsvej 15, 4. sal, Hellerup, Denmark, 2900
    Public contact
    Merete Nordentoft, Copenhagen Research Center for Mental Health, CORE, Merete.Nordentoft@regionh.dk
    Scientific contact
    Merete Nordentoft, Copenhagen Research Center for Mental Health, CORE, Merete.Nordentoft@regionh.dk
    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 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    1. To investigate the frequency of subjects who are not in treatment with antipsychotic medication and has remission of psychotic symptoms in the discontinuation group compared with the maintenance therapy group measured at one and two year follow up.
    Protection of trial subjects
    Safety was ensured by regular visits in the early intervention service, monthly telephonic assessment of psychotic symptoms and monitoring by Good Clinical Practice (GCP) including reports of adverse events/reactions and serious adverse events/reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 May 2016
    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
    Denmark: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    29
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Evaluated by medical doctors

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Data analyst, Assessor [2]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 intervention
    Arm description
    		 Patients within this arm received tapered discontinuation of their antipsychotic medication
    Arm type
    		 Tapered discontinuation

    Investigational medicinal product name
    Any antipsychotic medication approved for schizophrenia or schizophreniform psychosis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Oral drops, Tablet
    Routes of administration
    Intramuscular use, Oral use
    Dosage and administration details
    Study participants were tapered off their antipsychotic medication which they already took before entering the trial

    Arm title
    		 control
    Arm description
    		 Study participant received usual maintenance treatment with antipsychotic medication
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: assessors and researchers were blinded to the randomization. But neither study participant nor clinicians were blinded.
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: assessors and researchers were blinded to the randomization. But neither study participant nor clinicians were blinded.
    Number of subjects in period 1
    		intervention control
    Started
    14
    15
    Completed
    11
    12
    Not completed
    3
    3
         Consent withdrawn by subject
    1
    -
         Protocol deviation
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 Patients within this arm received tapered discontinuation of their antipsychotic medication

    Reporting group title
    control
    Reporting group description
    		 Study participant received usual maintenance treatment with antipsychotic medication

    Reporting group values
    		 intervention control Total
    Number of subjects
    		 14 15 29
    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)
    		 0 0 0
        Adults (18-64 years)
    		 14 15 29
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        not recorded
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 8 17
        Male
    		 5 7 12
        not recorded
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 Patients within this arm received tapered discontinuation of their antipsychotic medication

    Reporting group title
    control
    Reporting group description
    		 Study participant received usual maintenance treatment with antipsychotic medication

    Primary: Remission of psychotic symptoms (meaning SAPS ≤ 2) in minimum three months and no antipsychotic medication in minimum three months

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    End point title
    		 Remission of psychotic symptoms (meaning SAPS ≤ 2) in minimum three months and no antipsychotic medication in minimum three months [1]
    End point description
    End point type
    Primary
    End point timeframe
    7th of May 2018 to 1st of June 2020
    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 analyses were made due to an insufficient number of included participants and analysis made would potentially be misleading
    End point values
    		 intervention control
    Number of subjects analysed
    12
    13
    Units: participants
    5
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3rd of July to 6th of January 2020
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 -

    Reporting group title
    control
    Reporting group description
    		 -

    Serious adverse events
    		 intervention control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 14 (14.29%)
    3 / 15 (20.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Hospitalisation
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 intervention control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 15 (13.33%)
    Social circumstances
    Substance use
    Additional description: contact with police
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Treatment noncompliance
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Psychotic behaviour
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Mar 2018
    Change of inclusion criteria from patients having received 11 months treatment in an OPUS team to having 12 months left of treatment
    08 Mar 2019
    The use of a mobile phone application was discarded, adjustment of expected number of included study participants, inclusion of one more trial site and deletion of five-year follow-up.
    22 Jul 2020
    Deletion of two-year follow-up

    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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