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    Clinical Trial Results:
    Evaluation of the necessity of a pharmacological treatment with antipsychotics for the prevention of relapse in long-term stabilized schizophrenic patients: a randomized, single-blind, longitudinal trial

    Summary
    EudraCT number
    		 2013-000338-37
    Trial protocol
    		 DE  
    Global end of trial date
    22 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Nov 2020
    First version publication date
    18 Nov 2020
    Other versions
    Summary report(s)
    		 CSR_Reduce

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1723/1-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02307396
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität München, Fakultät für Medizin
    Sponsor organisation address
    Ismaninger Str. 22, Munich, Germany, 81675
    Public contact
    Prof. Dr. Stefan Leucht, Klinikum rechts der Isar der TU München, Klinik für Psychiatrie, Technische Universität München, Fakultät für Medizin, -49 89 4140 4249, stefan.leucht@tum.de
    Scientific contact
    Prof. Dr. Stefan Leucht, Klinikum rechts der Isar der TU München, Klinik für Psychiatrie, Technische Universität München, Fakultät für Medizin, -49 89 4140 4249, stefan.leucht@tum.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
    01 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the Trial is to evaluate for the first time employing high-Quality methodology, how long an antipsychotic relapse-prevention should be continued and to which time a patient is protected enough, so that a withdrawal of the medication seems appropriate. Relapse is defined as primary outcome.
    Protection of trial subjects
    The conduct of this clinical study met the local legal and regulatory requirements. The study was conducted in accordance the ethical principles of Good Clinical Practice (GCP). Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. The study was regularly monitored by the Sponsor and all investigators connected to the study were GCP trained.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2015
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Pre-screening processes were in place. Between 01.02.2015 and 22.06.2016 all patients were randomised.

    Pre-assignment
    Screening details
    		 Adult patients with chronic schizophrenia or schizoaffective disorder, who were treated with any antipsychotic drug except clozapine, who had not been hospitalized in the last 3 years and who were in symptomatic remission at baseline were included.

    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
    		 Assessor [1]
    Blinding implementation details
    The ratings were done by clinicians who were blind to the allocation

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Reducing medication
    Arm description
    		 In the intervention group, antipsychotic dose was gradually reduced and stopped if possible, based on the participant’s psychopathological status. As a rule the initial antipsychotic dose should be reduced by 1/6 every other week for the first three months, but this was adapted for each patient individually according to her/his needs and psychopathological status. So antipsychotic doses were reduced as far as possible for the first three months and then patients were followed-up with stable medication for three months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olanzapin
    Investigational medicinal product code
    N05AH03
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    5-20 milligram per day

    Investigational medicinal product name
    Amisulprid
    Investigational medicinal product code
    ATC N05AL05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100-1200 mg milligram(s) per day

    Investigational medicinal product name
    Risperidon
    Investigational medicinal product code
    ATC N05AX08
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1-10 mg milligram(s) per day

    Investigational medicinal product name
    Haloperidol
    Investigational medicinal product code
    ATC N05AD01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1-100 mg milligram(s) per day

    Investigational medicinal product name
    Quetiapin
    Investigational medicinal product code
    ATC N05AH04
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    100-800 mg milligram(s) per day

    Investigational medicinal product name
    Aripiprazol
    Investigational medicinal product code
    ATC N05AX12
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5-30 mg milligram(s) per day

    Investigational medicinal product name
    Perphenazin
    Investigational medicinal product code
    ATC N05AB03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4-24 mg milligram(s) total

    Investigational medicinal product name
    Sulpirid
    Investigational medicinal product code
    ATC N05AL01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50-1000 mg milligram(s) total

    Investigational medicinal product name
    Bromperidol
    Investigational medicinal product code
    ATC N05AD06
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    1-10 mg milligram(s) per day

    Investigational medicinal product name
    Zuclopenthixol
    Investigational medicinal product code
    ATC N05AF05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2-75 mg milligram(s) per day

    Investigational medicinal product name
    Thioridazin
    Investigational medicinal product code
    ATC N05AC02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25-600 mg milligram(s) per day

    Investigational medicinal product name
    Paliperidon
    Investigational medicinal product code
    ATC N05AX13
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1-12 mg milligram(s) per day

    Investigational medicinal product name
    Ziprasidon
    Investigational medicinal product code
    ATC N05AE04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20-160 mg milligram(s) total

    Investigational medicinal product name
    Benperidol
    Investigational medicinal product code
    ATC N05AD07
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2-40 mg milligram(s) per day

    Investigational medicinal product name
    Fluspirilen
    Investigational medicinal product code
    N05AG01
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4-8 mg milligram(s) total

    Investigational medicinal product name
    Pimozid
    Investigational medicinal product code
    ATC N05AG02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1-16 mg milligram(s) per day

    Investigational medicinal product name
    Perazin
    Investigational medicinal product code
    ATC N05AB10
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25-600 mg milligram(s) per day

    Investigational medicinal product name
    Fluphenazin
    Investigational medicinal product code
    ATC N05AB02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2-40 mg milligram(s) per day

    Investigational medicinal product name
    Flupentixol
    Investigational medicinal product code
    ATC N05AF01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1-60 mg milligram(s) per day

    Investigational medicinal product name
    Levomepromazin
    Investigational medicinal product code
    ATC N05AA02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15-150 mg milligram(s) per day

    Investigational medicinal product name
    Chlorprothixen
    Investigational medicinal product code
    ATC N05AF03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15-200 mg milligram(s) per day

    Investigational medicinal product name
    Sertindol
    Investigational medicinal product code
    ATC N05AE03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4-20 mg milligram(s) per day

    Arm title
    		 Control group
    Arm description
    		 Medication in the control group was maintained.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Olanzapin
    Investigational medicinal product code
    N05AH03
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    5-20 milligram per day

    Investigational medicinal product name
    Amisulprid
    Investigational medicinal product code
    ATC N05AL05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100-1200 mg milligram(s) per day

    Investigational medicinal product name
    Risperidon
    Investigational medicinal product code
    ATC N05AX08
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1-10 mg milligram(s) per day

    Investigational medicinal product name
    Haloperidol
    Investigational medicinal product code
    ATC N05AD01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1-100 mg milligram(s) per day

    Investigational medicinal product name
    Quetiapin
    Investigational medicinal product code
    ATC N05AH04
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    100-800 mg milligram(s) per day

    Investigational medicinal product name
    Aripiprazol
    Investigational medicinal product code
    ATC N05AX12
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5-30 mg milligram(s) per day

    Investigational medicinal product name
    Perphenazin
    Investigational medicinal product code
    ATC N05AB03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4-24 mg milligram(s) total

    Investigational medicinal product name
    Sulpirid
    Investigational medicinal product code
    ATC N05AL01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50-1000 mg milligram(s) total

    Investigational medicinal product name
    Bromperidol
    Investigational medicinal product code
    ATC N05AD06
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    1-10 mg milligram(s) per day

    Investigational medicinal product name
    Zuclopenthixol
    Investigational medicinal product code
    ATC N05AF05
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2-75 mg milligram(s) per day

    Investigational medicinal product name
    Thioridazin
    Investigational medicinal product code
    ATC N05AC02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25-600 mg milligram(s) per day

    Investigational medicinal product name
    Paliperidon
    Investigational medicinal product code
    ATC N05AX13
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1-12 mg milligram(s) per day

    Investigational medicinal product name
    Ziprasidon
    Investigational medicinal product code
    ATC N05AE04
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20-160 mg milligram(s) total

    Investigational medicinal product name
    Benperidol
    Investigational medicinal product code
    ATC N05AD07
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2-40 mg milligram(s) per day

    Investigational medicinal product name
    Fluspirilen
    Investigational medicinal product code
    N05AG01
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4-8 mg milligram(s) total

    Investigational medicinal product name
    Pimozid
    Investigational medicinal product code
    ATC N05AG02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1-16 mg milligram(s) per day

    Investigational medicinal product name
    Perazin
    Investigational medicinal product code
    ATC N05AB10
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25-600 mg milligram(s) per day

    Investigational medicinal product name
    Fluphenazin
    Investigational medicinal product code
    ATC N05AB02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2-40 mg milligram(s) per day

    Investigational medicinal product name
    Flupentixol
    Investigational medicinal product code
    ATC N05AF01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1-60 mg milligram(s) per day

    Investigational medicinal product name
    Levomepromazin
    Investigational medicinal product code
    ATC N05AA02
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15-150 mg milligram(s) per day

    Investigational medicinal product name
    Chlorprothixen
    Investigational medicinal product code
    ATC N05AF03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15-200 mg milligram(s) per day

    Investigational medicinal product name
    Sertindol
    Investigational medicinal product code
    ATC N05AE03
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4-20 mg milligram(s) per day

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The ratings were done by clinicians who were blind to the allocation.
    Number of subjects in period 1
    		Reducing medication Control group
    Started
    11
    9
    Completed
    11
    8
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Reducing medication
    Reporting group description
    		 In the intervention group, antipsychotic dose was gradually reduced and stopped if possible, based on the participant’s psychopathological status. As a rule the initial antipsychotic dose should be reduced by 1/6 every other week for the first three months, but this was adapted for each patient individually according to her/his needs and psychopathological status. So antipsychotic doses were reduced as far as possible for the first three months and then patients were followed-up with stable medication for three months.

    Reporting group title
    Control group
    Reporting group description
    		 Medication in the control group was maintained.

    Reporting group values
    		 Reducing medication Control group Total
    Number of subjects
    		 11 9 20
    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)
    		 44.73 ± 10.33 46.11 ± 12.09 -
    Gender categorical
    Units: Subjects
        Female
    		 5 3 8
        Male
    		 6 6 12
    PANSS overall
    Units: PANSS Units
        arithmetic mean (standard deviation)
    		 50.09 ± 10.41 47.67 ± 8.09 -

    End points

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    End points reporting groups
    Reporting group title
    Reducing medication
    Reporting group description
    		 In the intervention group, antipsychotic dose was gradually reduced and stopped if possible, based on the participant’s psychopathological status. As a rule the initial antipsychotic dose should be reduced by 1/6 every other week for the first three months, but this was adapted for each patient individually according to her/his needs and psychopathological status. So antipsychotic doses were reduced as far as possible for the first three months and then patients were followed-up with stable medication for three months.

    Reporting group title
    Control group
    Reporting group description
    		 Medication in the control group was maintained.

    Primary: Relapse

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    End point title
    		 Relapse
    End point description
    The primary outcome was relapse defined as a CGI > 3 AND at least two of the following positive PANSS items > 3: delusions, conceptual disorganisation, hallucinations, mannerisms and posturing and unusual thought content assessed at every visit.
    End point type
    Primary
    End point timeframe
    Whole study period 26 weeks.
    End point values
    		 Reducing medication Control group
    Number of subjects analysed
    11
    9
    Units: Number of relapses
    1
    2
    Statistical analysis title
    		 Relapse
    Statistical analysis description
    The primary dichotomous outcome was the number of patients relapsed in the intervention group compared with that in the control group. Fisher’s Exact Test was applied to compare the number of relapsed patients.
    Comparison groups
    Reducing medication v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.566
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The reporting of AEs / SAEs begins with the patient's baseline visit and ends 7 days after termination of the study participation or or 7 days after (early) termination.
    Adverse event reporting additional description
    Events caused by the underlying disease or by routine treatments were not recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    999
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The study had no serious adverse events and no adverse events. Side effects were recorded according to the UKU-scale. The results are presented in details in Table 1a+1b of the publication of the study. The PDF is attached to the trial results and avialable open access. (https://doi.org/10.1007/s00406-020-01109-y)

    More information

    		 Close Top of page

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/3206272
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