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    Clinical Trial Results:
    A Multicentre, 8-week, Single-arm, Open-label, Pragmatic Trial to Explore Acceptance and Performance of Using a Digital Medicine System with Healthcare Professionals and Adult Subjects with Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic (Aripiprazole, Olanzapine, Quetiapine, or Risperidone)

    Summary
    EudraCT number
    		 2017-004602-17
    Trial protocol
    		 GB  
    Global end of trial date
    06 Sep 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Oct 2020
    First version publication date
    16 May 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    031-201-00186
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03568500
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Sponsor organisation address
    2440 Research Boulevard, Rockville, Maryland, United States, 20850
    Public contact
    Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., 609 524-6788, clinicaltransparency@otsuka-us.com
    Scientific contact
    Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc., 609 524-6788, clinicaltransparency@otsuka-us.com
    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
    06 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Explore the acceptance and performance of the digital medicine system (DMS) with healthcare professionals and adult participants with schizophrenia, schizoaffective disorder, or first episode psychosis.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2018
    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
    United Kingdom: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    44
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial enrolled participants with a confirmed clinical diagnosis of schizophrenia, schizoaffective disorder, or first episode psychosis.

    Pre-assignment
    Screening details
    		 Participants in this trial received at least 1 CoEncapsulated miniature ingestible event marker in a tablet and a medicinal product originator tablet of either aripiprazole, olanzapine, or quetiapine (participants were allowed to take risperidone, though no participant took risperidone in this trial) as prescribed by their healthcare professional.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aripiprazole
    Arm description
    		 Participants were treated with at least 1 CoEncapsulated (CoE) oral aripiprazole tablet, wearing the digital medicine system (DMS) patch, and using the associated smartphone app for a total of 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aripiprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablet; dosage determined by the healthcare professional.

    Investigational medicinal product name
    Digital Medicine System
    Investigational medicinal product code
    Other name
    DMS
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The DMS included a drug-device combination of a CoEncapsulated (CoE) drug, a patch, and application software to convey level of activity and rest, and to mark events through the act of ingestion.

    Arm title
    		 Olanzapine
    Arm description
    		 Participants were treated with at least 1 CoE oral olanzapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Digital Medicine System
    Investigational medicinal product code
    Other name
    DMS
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The DMS included a drug-device combination of a CoEncapsulated (CoE) drug, a patch, and application software to convey level of activity and rest, and to mark events through the act of ingestion.

    Investigational medicinal product name
    Olanzapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablet; dosage determined by the healthcare professional.

    Arm title
    		 Quetiapine
    Arm description
    		 Participants were treated with at least 1 CoE oral quetiapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Digital Medicine System
    Investigational medicinal product code
    Other name
    DMS
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The DMS included a drug-device combination of a CoEncapsulated (CoE) drug, a patch, and application software to convey level of activity and rest, and to mark events through the act of ingestion.

    Investigational medicinal product name
    Quetiapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablet; dosage determined by the healthcare professional.

    Number of subjects in period 1
    		Aripiprazole Olanzapine Quetiapine
    Started
    18
    20
    6
    Received At Least 1 Dose of Study Drug
    18
    19
    6
    Completed
    8
    14
    2
    Not completed
    10
    6
    4
         Physician decision
    1
    -
    -
         Consent withdrawn by subject
    4
    2
    -
         Participant Noncompliance
    1
    1
    -
         Adverse event, non-fatal
    1
    1
    2
         Technical Problems
    2
    1
    -
         Lost to follow-up
    1
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aripiprazole
    Reporting group description
    		 Participants were treated with at least 1 CoEncapsulated (CoE) oral aripiprazole tablet, wearing the digital medicine system (DMS) patch, and using the associated smartphone app for a total of 8 weeks.

    Reporting group title
    Olanzapine
    Reporting group description
    		 Participants were treated with at least 1 CoE oral olanzapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.

    Reporting group title
    Quetiapine
    Reporting group description
    		 Participants were treated with at least 1 CoE oral quetiapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.

    Reporting group values
    		 Aripiprazole Olanzapine Quetiapine Total
    Number of subjects
    		 18 20 6 44
    Age categorical
    Units:
    Age continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 31.6 ( 9.6 ) 38.0 ( 11.4 ) 30.8 ( 8.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 4 3 15
        Male
    		 10 16 3 29
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 4 4 0 8
        White
    		 14 15 6 35
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 1 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0
        Not Hispanic or Latino
    		 17 18 5 40
        Unknown or Not Reported
    		 1 2 1 4
    Disease Diagnosis
    Units: Subjects
        Schizophrenia: Schizophrenia
    		 5 13 0 18
        Schizophrenia: Schizoaffective Disorder
    		 4 4 2 10
        Schizophrenia: First Episode Psychosis
    		 9 3 4 16

    End points

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    End points reporting groups
    Reporting group title
    Aripiprazole
    Reporting group description
    		 Participants were treated with at least 1 CoEncapsulated (CoE) oral aripiprazole tablet, wearing the digital medicine system (DMS) patch, and using the associated smartphone app for a total of 8 weeks.

    Reporting group title
    Olanzapine
    Reporting group description
    		 Participants were treated with at least 1 CoE oral olanzapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.

    Reporting group title
    Quetiapine
    Reporting group description
    		 Participants were treated with at least 1 CoE oral quetiapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.

    Subject analysis set title
    Schizophrenia
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had a confirmed clinical diagnosis of schizophrenia (defined by International Classification of Disease-10 codes F20 and F25). There was no limit on the duration of illness. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional.

    Subject analysis set title
    Schizoaffective Disorder
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had a confirmed clinical diagnosis of schizoaffective disorder (defined by International Classification of Disease-10 codes F20 and F25). There was no limit on the duration of illness. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional.

    Subject analysis set title
    First Episode Psychosis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had a confirmed clinical diagnosis of first episode psychosis using case note review. The duration of illness was defined as less than 3 years since presentation to the mental health team or first antipsychotic prescription. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional.

    Subject analysis set title
    Total
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional.

    Subject analysis set title
    Schizophrenia
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had a confirmed clinical diagnosis of schizophrenia (defined by International Classification of Disease-10 codes F20 and F25). There was no limit on the duration of illness. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the HCP.

    Subject analysis set title
    Schizoaffective Disorder
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had a confirmed clinical diagnosis of schizoaffective disorder (defined by International Classification of Disease-10 codes F20 and F25). There was no limit on the duration of illness. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the HCP.

    Subject analysis set title
    First Episode Psychosis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had a confirmed clinical diagnosis of first episode psychosis using case note review. The duration of illness was defined as less than 3 years since presentation to the mental health team or first antipsychotic prescription. Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the HCP.

    Primary: Percentage Of Days With Good Patch Coverage

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    End point title
    		 Percentage Of Days With Good Patch Coverage [1]
    End point description
    The DMS includes a drug-device combination of a CoE product, a wearable sensor patch, and application software (smartphone) to record activity and rest and mark events through the act of ingestion. The CoE product consists of an approved antipsychotic medication enclosed with an Ingestible Sensor Pill (miniature ingestible event marker in tablet [MIT]). The sensor patch detects and records each MIT ingestion, as well as other physiologic and behavioral data. Good patch coverage for a specific day was defined as having either at least 80% patch data available (80% of the day the patch was worn and data was collected as noted via the accelerometer channel) or the MIT was detected within the 24-hour period, for each day while the participant was in the trial. The percentage of days was calculated as the number of days with good patch coverage divided by the total number of trial days for each participant. Descriptive statistics were performed for this outcome measure.
    End point type
    Primary
    End point timeframe
    Up to 8 weeks
    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: Quantitative statistical analysis (for example, a p-value) was not performed. Descriptive statistics are included (mean and standard deviation).
    End point values
    		 Schizophrenia Schizoaffective Disorder First Episode Psychosis Total
    Number of subjects analysed
    18
    9
    16
    43
    Units: percentage of days
        arithmetic mean (standard deviation)
    64.34 ( 20.24 )
    62.99 ( 37.68 )
    62.51 ( 27.53 )
    63.37 ( 26.60 )
    No statistical analyses for this end point

    Secondary: Participant Adherence

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    End point title
    		 Participant Adherence
    End point description
    The DMS includes a drug-device combination of a CoE product, a wearable sensor patch, and application software (smartphone) to record activity and rest and mark events through the act of ingestion. The CoE product consists of an approved antipsychotic medication enclosed with an Ingestible Sensor Pill (MIT). The sensor patch detects and records each MIT ingestion, as well as other physiologic and behavioral data. Participant adherence was measured as the detected MITs over the expected MITs ingested during the trial days with good patch coverage. The more the participant successfully engaged in a number of processes across the 8-week trial, the greater the measured adherence. Descriptive statistics were performed for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 Total Schizophrenia Schizoaffective Disorder First Episode Psychosis
    Number of subjects analysed
    42
    18
    8
    16
    Units: percentage of MITs
        arithmetic mean (standard deviation)
    86.57 ( 14.47 )
    88.94 ( 8.06 )
    72.29 ( 25.65 )
    91.04 ( 7.37 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Week 24 (+ 7 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Aripiprazole
    Reporting group description
    		 Participants were treated with at least 1 CoEncapsulated (CoE) oral aripiprazole tablet, wearing the digital medicine system (DMS) patch, and using the associated smartphone app for a total of 8 weeks.

    Reporting group title
    Olanzapine
    Reporting group description
    		 Participants were treated with at least 1 CoE oral olanzapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.

    Reporting group title
    Quetiapine
    Reporting group description
    		 Participants were treated with at least 1 CoE oral quetiapine tablet, wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks.

    Reporting group title
    Total
    Reporting group description
    		 Participants were treated with at least 1 CoE oral atypical antipsychotic tablet (aripiprazole, olanzapine, or quetiapine), wearing the DMS patch, and using the associated smartphone app for a total of 8 weeks. The treatment medication decision was determined by the healthcare professional.

    Serious adverse events
    		 Aripiprazole Olanzapine Quetiapine Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Aripiprazole Olanzapine Quetiapine Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 18 (22.22%)
    2 / 19 (10.53%)
    3 / 6 (50.00%)
    9 / 43 (20.93%)
    General disorders and administration site conditions
    Medical device site irritation
         subjects affected / exposed
    4 / 18 (22.22%)
    2 / 19 (10.53%)
    3 / 6 (50.00%)
    9 / 43 (20.93%)
         occurrences all number
    5
    2
    4
    11

    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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    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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