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    Clinical Trial Results:
    A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of Schizophrenia

    Summary
    EudraCT number
    		 2020-000094-24
    Trial protocol
    		 LV   PL   BG   HR  
    Global end of trial date
    21 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2025
    First version publication date
    06 Jul 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-8189-008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.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
    21 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily [QD]) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5thEdition (DSM-5) criteria. The primary hypotheses were the following: (1)that MK-8189 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS)total score, and (2) that MK-8189 16 mg is superior to placebo in reducing the Week 6 mean change from baseline in PANSS total score. With Amendment 4, enrollment was changed to approximately 500 participants with removal of the MK-8189 8 mg treatment arm. Participants enrolled before Amendment 4 who were assigned to MK-8189 8 mg QD remained on that dose regimen per protocol.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2020
    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
    Bulgaria: 47
    Country: Number of subjects enrolled
    Croatia: 29
    Country: Number of subjects enrolled
    Japan: 7
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Romania: 18
    Country: Number of subjects enrolled
    Russian Federation: 25
    Country: Number of subjects enrolled
    Serbia: 32
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    Ukraine: 28
    Country: Number of subjects enrolled
    United States: 294
    Worldwide total number of subjects
    499
    EEA total number of subjects
    109
    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)
    499
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled and randomized at 75 study sites in 11 countries.

    Pre-assignment
    Screening details
    		 Randomization into the MK-8189 8 mg arm ceased as of Amendment 4.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MK-8189 8 mg
    Arm description
    		 Participants received MK-8189 8 mg once daily (QD) from Weeks 1 to 12, with 2 weeks of follow-up.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-8189
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-8189 administered QD at a dose of 8 mg,16 mg, or 24 mg via oral tablet.

    Arm title
    		 MK-8189 16 mg
    Arm description
    		 Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-8189
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-8189 administered QD at a dose of 8 mg,16 mg, or 24 mg via oral tablet.

    Arm title
    		 MK-8189 24 mg
    Arm description
    		 Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-8189
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-8189 administered QD at a dose of 8 mg,16 mg, or 24 mg via oral tablet.

    Arm title
    		 Risperidone 6 mg
    Arm description
    		 Participants received risperidone 6 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Risperidone
    Investigational medicinal product code
    Other name
    RISPERDAL
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Risperidone administered QD at a dose of 6 mg via oral capsule.

    Arm title
    		 Placebo and MK-8189 24 mg
    Arm description
    		 Participants received placebo QD from Weeks 1 to 6 and MK-8189 24 mg from Weeks 7 to 12, with 2 weeks of follow-up.
    Arm type
    		 Placebo

    Investigational medicinal product name
    MK-8189
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-8189 administered QD at a dose of 8 mg,16 mg, or 24 mg via oral tablet.

    Number of subjects in period 1
    		MK-8189 8 mg MK-8189 16 mg MK-8189 24 mg Risperidone 6 mg Placebo and MK-8189 24 mg
    Started
    41
    132
    132
    65
    129
    Completed
    14
    64
    61
    37
    70
    Not completed
    27
    68
    71
    28
    59
         Adverse event, serious fatal
    -
    1
    -
    -
    -
         Physician decision
    3
    8
    15
    2
    11
         Consent withdrawn by subject
    19
    44
    40
    21
    39
         Miscellaneous
    3
    12
    9
    4
    6
         Lost to follow-up
    2
    3
    7
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MK-8189 8 mg
    Reporting group description
    		 Participants received MK-8189 8 mg once daily (QD) from Weeks 1 to 12, with 2 weeks of follow-up.

    Reporting group title
    MK-8189 16 mg
    Reporting group description
    		 Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.

    Reporting group title
    MK-8189 24 mg
    Reporting group description
    		 Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.

    Reporting group title
    Risperidone 6 mg
    Reporting group description
    		 Participants received risperidone 6 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.

    Reporting group title
    Placebo and MK-8189 24 mg
    Reporting group description
    		 Participants received placebo QD from Weeks 1 to 6 and MK-8189 24 mg from Weeks 7 to 12, with 2 weeks of follow-up.

    Reporting group values
    		 MK-8189 8 mg MK-8189 16 mg MK-8189 24 mg Risperidone 6 mg Placebo and MK-8189 24 mg Total
    Number of subjects
    		 41 132 132 65 129 499
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 41 132 132 65 129 499
        From 65-84 years
    		 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 35.7 ( 8.9 ) 39.4 ( 9.0 ) 36.9 ( 9.2 ) 38.5 ( 9.6 ) 40.2 ( 9.2 ) -
    Sex: Female, Male
    Units:
        Female
    		 12 46 42 25 42 167
        Male
    		 29 86 90 40 87 332
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 2 3 2 1 4 12
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 18 59 59 29 57 222
        White
    		 20 68 70 34 66 258
        More than one race
    		 1 1 1 1 2 6
        Unknown or Not Reported
    		 0 1 0 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 14 10 4 11 40
        Not Hispanic or Latino
    		 40 117 121 61 118 457
        Unknown or Not Reported
    		 0 1 1 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    MK-8189 8 mg
    Reporting group description
    		 Participants received MK-8189 8 mg once daily (QD) from Weeks 1 to 12, with 2 weeks of follow-up.

    Reporting group title
    MK-8189 16 mg
    Reporting group description
    		 Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.

    Reporting group title
    MK-8189 24 mg
    Reporting group description
    		 Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.

    Reporting group title
    Risperidone 6 mg
    Reporting group description
    		 Participants received risperidone 6 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.

    Reporting group title
    Placebo and MK-8189 24 mg
    Reporting group description
    		 Participants received placebo QD from Weeks 1 to 6 and MK-8189 24 mg from Weeks 7 to 12, with 2 weeks of follow-up.

    Primary: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6

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    End point title
    		 Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6
    End point description
    The PANSS assesses the severity of schizophrenia symptoms through a 30-item clinician-rated inventory organized into a positive subscale (7 items), a negative subscale (7 items) and a general psychopathology subscale (16 items). For each item, symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme). The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranges from 30 (lowest total score) to 210 (highest total score). Higher and lower change scores reflect symptom worsening and improvement, respectively. Per protocol, the effect of the 8 mg dose was not assessed; risperidone and placebo were active and inactive controls, respectively. All participants who receive ≥1 dose of MK-8189 (16 mg or 24 mg), risperidone, or placebo, and have both a baseline measurement and ≥1valid post-baseline assessment, are included.
    End point type
    Primary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-8189 8 mg MK-8189 16 mg MK-8189 24 mg Risperidone 6 mg Placebo and MK-8189 24 mg
    Number of subjects analysed
    0 [1]
    85
    68
    42
    91
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    ( to )
    -20.7 (-24.1 to -17.3)
    -18.5 (-22.1 to -15.0)
    -24.0 (-28.8 to -19.2)
    -17.8 (-21.2 to -14.5)
    Notes
    [1] - Per protocol, the MK-8189 8 mg arm was excluded from the analysis.
    Statistical analysis title
    		 MK-8189 24 mg PANSS Week 6
    Comparison groups
    MK-8189 24 mg v Placebo and MK-8189 24 mg
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 = 0.784
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 4.9
    Notes
    [2] - It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS change from baseline
    Statistical analysis title
    		 MK-8189 16 mg PANSS Week 6
    Comparison groups
    MK-8189 16 mg v Placebo and MK-8189 24 mg
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    P-value
    		 = 0.241
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -2.8
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 2.6
    Notes
    [3] - It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS change from baseline

    Primary: Number of participants who experience one or more adverse events (AEs)

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    End point title
    		 Number of participants who experience one or more adverse events (AEs) [4]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, events were assessed for the first 6 weeks of treatment. All participants who received ≥1 dose of study intervention are included.
    End point type
    Primary
    End point timeframe
    Up to Week 6
    Notes
    [4] - 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: Per protocol, only descriptive statistics are presented.
    End point values
    		 MK-8189 8 mg MK-8189 16 mg MK-8189 24 mg Risperidone 6 mg Placebo and MK-8189 24 mg
    Number of subjects analysed
    41
    132
    132
    65
    129
    Units: Participants
    29
    85
    94
    31
    70
    No statistical analyses for this end point

    Primary: Number of participants who discontinued from study intervention due to AE

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    End point title
    		 Number of participants who discontinued from study intervention due to AE [5]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, events were assessed for the first 6 weeks of treatment. All participants who received ≥1 dose of study intervention are included.
    End point type
    Primary
    End point timeframe
    Up to Week 6
    Notes
    [5] - 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: Per protocol, only descriptive statistics are presented.
    End point values
    		 MK-8189 8 mg MK-8189 16 mg MK-8189 24 mg Risperidone 6 mg Placebo and MK-8189 24 mg
    Number of subjects analysed
    41
    132
    132
    65
    129
    Units: Participants
    8
    17
    33
    8
    16
    No statistical analyses for this end point

    Secondary: Change from baseline in PANSS positive subscale (PSS) score at Week 6

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    End point title
    		 Change from baseline in PANSS positive subscale (PSS) score at Week 6
    End point description
    The PANSS Positive Subscale (PSS) assesses the severity of schizophrenia symptoms. The PANSS PSS score was calculated as the sum of the rating assigned to each of the 7 PSS items and ranges from 7 (lowest total score) to 49 (highest total score). Higher and lower change scores reflect symptom worsening and improvement, respectively. Per protocol, the effect of the 8 mg dose was not assessed; risperidone and placebo were active and inactive controls, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-8189 8 mg MK-8189 16 mg MK-8189 24 mg Risperidone 6 mg Placebo and MK-8189 24 mg
    Number of subjects analysed
    0 [6]
    85
    68
    42
    91
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    ( to )
    -7.1 (-8.2 to -6.0)
    -7.2 (-8.3 to -6.0)
    -7.7 (-9.3 to -6.1)
    -5.8 (-6.9 to -4.7)
    Notes
    [6] - Per protocol, the MK-8189 8 mg arm was excluded from the analysis.
    Statistical analysis title
    		 MK-8189 24 mg PANSS PSS Week 6
    Comparison groups
    MK-8189 24 mg v Placebo and MK-8189 24 mg
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    P-value
    		 = 0.094
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 0.5
    Notes
    [7] - It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline
    Statistical analysis title
    		 MK-8189 16 mg PANSS PSS Week 6
    Comparison groups
    MK-8189 16 mg v Placebo and MK-8189 24 mg
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    P-value
    		 = 0.096
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 0.5
    Notes
    [8] - It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline

    Secondary: Change from baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Week 6

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    End point title
    		 Change from baseline in Clinical Global Impression-Severity of Illness (CGI-S) score at Week 6
    End point description
    The CGI-S is a single item 7-point clinician rated scale for assessing the global severity of the participant’s illness. CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill); higher and lower change from baseline scores indicate symptom worsening and improvement, respectively. Per protocol, the effect of the 8 mg dose was not assessed; risperidone and placebo were active and inactive controls, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-8189 8 mg MK-8189 16 mg MK-8189 24 mg Risperidone 6 mg Placebo and MK-8189 24 mg
    Number of subjects analysed
    0 [9]
    83
    68
    42
    88
    Units: Score on a scale
        least squares mean (confidence interval 95%)
    ( to )
    -1.1 (-1.3 to -0.9)
    -1.0 (-1.2 to -0.8)
    -1.3 (-1.5 to -1.0)
    -1.0 (-1.2 to -0.8)
    Notes
    [9] - Per protocol, the MK-8189 8 mg arm was excluded from the analysis.
    Statistical analysis title
    		 MK-8189 24 mg CGI-S Week 6
    Comparison groups
    MK-8189 24 mg v Placebo and MK-8189 24 mg
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    P-value
    		 = 0.959
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.3
    Notes
    [10] - It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline
    Statistical analysis title
    		 MK-8189 16 mg CGI-S Week 6
    Comparison groups
    MK-8189 16 mg v Placebo and MK-8189 24 mg
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    P-value
    		 = 0.254
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.1
    Notes
    [11] - It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline

    Secondary: Change from baseline in body weight at Week 12

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    End point title
    		 Change from baseline in body weight at Week 12
    End point description
    The change from baseline in body weigh was determined at Week 12. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Per protocol, the effect of the 8 mg dose was not assessed; risperidone and placebo were active and inactive controls, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 MK-8189 8 mg MK-8189 16 mg MK-8189 24 mg Risperidone 6 mg Placebo and MK-8189 24 mg
    Number of subjects analysed
    0 [12]
    56
    45
    34
    52
    Units: Kilograms
        least squares mean (confidence interval 95%)
    ( to )
    -5.4 (-6.5 to -4.4)
    -4.3 (-5.4 to -3.2)
    3.0 (1.6 to 4.4)
    -2.3 (-3.4 to -1.3)
    Notes
    [12] - Per protocol, the MK-8189 8 mg arm was excluded from the analysis.
    Statistical analysis title
    		 MK-8189 24 mg Body Weight Week 12
    Comparison groups
    MK-8189 24 mg v Risperidone 6 mg
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -7.3
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -9.3
         upper limit
    		 -5.2
    Notes
    [13] - It was hypothesized that MK-8189 24 mg is superior to risperidone in reducing Week 12 body weight change from baseline
    Statistical analysis title
    		 MK-8189 16 mg Body Weight Week 12
    Comparison groups
    MK-8189 16 mg v Risperidone 6 mg
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 [14]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -8.5
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -10.4
         upper limit
    		 -6.5
    Notes
    [14] - It was hypothesized that MK-8189 16 mg is superior to risperidone in reducing Week 12 body weight change from baseline

    Secondary: Change from baseline in body weight at Week 6

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    End point title
    		 Change from baseline in body weight at Week 6
    End point description
    The change from baseline in body weigh was determined at Week 6. Negative and positive values represent body weight loss and gain from baseline, respectively. Weight was measured using a standardized scale. Per protocol, the effect of the 8 mg dose was not assessed; risperidone and placebo were active and inactive controls, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-8189 8 mg MK-8189 16 mg MK-8189 24 mg Risperidone 6 mg Placebo and MK-8189 24 mg
    Number of subjects analysed
    0 [15]
    86
    75
    44
    91
    Units: Kilograms
        least squares mean (confidence interval 95%)
    ( to )
    -3.2 (-3.9 to -2.5)
    -2.8 (-3.5 to -2.1)
    2.8 (1.8 to 3.8)
    0.5 (-0.2 to 1.2)
    Notes
    [15] - Per protocol, the MK-8189 8 mg arm was excluded from the analysis.
    Statistical analysis title
    		 MK-8189 24 mg Body Weight Week 6
    Comparison groups
    MK-8189 24 mg v Risperidone 6 mg
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 [16]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -3.3
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 -2.1
    Notes
    [16] - It was hypothesized that MK-8189 24 mg is superior to risperidone in reducing Week 12 body weight change from baseline
    Statistical analysis title
    		 MK-8189 16 mg Body Weight Week 6
    Comparison groups
    MK-8189 16 mg v Risperidone 6 mg
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 [17]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -3.7
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 -2.5
    Notes
    [17] - It was hypothesized that MK-8189 16 mg is superior to risperidone in reducing Week 6 body weight change from baseline

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to ~14 weeks
    Adverse event reporting additional description
    All treated participants are included. To accommodate the different treatments in the "Placebo and MK-8189 24 mg", data from Weeks 1 to 6 and Weeks 7 to 12 are presented separately.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    MK-8189 8 mg Weeks 1 to 6
    Reporting group description
    		 Participants received MK-8189 8 mg QD from Weeks 1 to 6.

    Reporting group title
    MK-8189 16 mg Weeks 1 to 6
    Reporting group description
    		 Participants (who received MK-8189 16 mg Weeks 1 to 6) received MK-8189 16 mg QD from Weeks 1 to 6.

    Reporting group title
    MK-8189 24 mg Weeks 1 to 6
    Reporting group description
    		 Participants received MK-8189 24 mg QD from Weeks 1 to 6.

    Reporting group title
    Risperidone 6 mg Weeks 1 to 6
    Reporting group description
    		 Participants received risperidone 6 mg QD from Weeks 1 to 6.

    Reporting group title
    Placebo Weeks 1 to 6
    Reporting group description
    		 Participants received placebo QD from Weeks 1 to 6.

    Reporting group title
    MK-8189 16 mg Weeks 7 to 12
    Reporting group description
    		 Participants (who received MK-8189 16 mg Weeks 1 to 6) received MK-8189 16 mg QD from Weeks 7 to 12.

    Reporting group title
    MK-8189 8 mg Weeks 7 to 12
    Reporting group description
    		 Participants (who received MK-8189 8 mg Weeks 1 to 6) received MK-8189 8 mg QD from Weeks 7 to 12.

    Reporting group title
    Risperidone 6 mg Weeks 7 to 12
    Reporting group description
    		 Participants (who received risperidone 6 mg Weeks 1 to 6) received risperidone 8 mg QD from Weeks 7 to 12.

    Reporting group title
    MK-8189 24 mg Weeks 7 to 12
    Reporting group description
    		 Participants (who received MK-8189 24 mg) received MK-8189 24 mg QD from Weeks 7 to 12.

    Reporting group title
    MK-8189 24 mg Weeks 7 to 12 (Placebo Weeks 1 to 6)
    Reporting group description
    		 Participants (who received placebo Weeks 1 to 6) received MK-8189 24 mg Weeks 7 to 12.

    Serious adverse events
    		 MK-8189 8 mg Weeks 1 to 6 MK-8189 16 mg Weeks 1 to 6 MK-8189 24 mg Weeks 1 to 6 Risperidone 6 mg Weeks 1 to 6 Placebo Weeks 1 to 6 MK-8189 16 mg Weeks 7 to 12 MK-8189 8 mg Weeks 7 to 12 Risperidone 6 mg Weeks 7 to 12 MK-8189 24 mg Weeks 7 to 12 MK-8189 24 mg Weeks 7 to 12 (Placebo Weeks 1 to 6)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 41 (2.44%)
    8 / 132 (6.06%)
    6 / 132 (4.55%)
    2 / 65 (3.08%)
    0 / 129 (0.00%)
    4 / 75 (5.33%)
    3 / 17 (17.65%)
    0 / 39 (0.00%)
    3 / 60 (5.00%)
    2 / 85 (2.35%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Toxicity to various agents
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 132 (0.00%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    1 / 60 (1.67%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 132 (0.76%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 132 (0.76%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 132 (0.76%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 132 (0.76%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 132 (0.00%)
    0 / 132 (0.00%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 132 (0.00%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    1 / 75 (1.33%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 132 (0.76%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    1 / 75 (1.33%)
    1 / 17 (5.88%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 132 (1.52%)
    5 / 132 (3.79%)
    1 / 65 (1.54%)
    0 / 129 (0.00%)
    3 / 75 (4.00%)
    2 / 17 (11.76%)
    0 / 39 (0.00%)
    2 / 60 (3.33%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 132 (0.00%)
    1 / 132 (0.76%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 132 (0.00%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    1 / 60 (1.67%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle rigidity
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 132 (0.76%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 132 (0.76%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 132 (0.76%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 132 (0.76%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MK-8189 8 mg Weeks 1 to 6 MK-8189 16 mg Weeks 1 to 6 MK-8189 24 mg Weeks 1 to 6 Risperidone 6 mg Weeks 1 to 6 Placebo Weeks 1 to 6 MK-8189 16 mg Weeks 7 to 12 MK-8189 8 mg Weeks 7 to 12 Risperidone 6 mg Weeks 7 to 12 MK-8189 24 mg Weeks 7 to 12 MK-8189 24 mg Weeks 7 to 12 (Placebo Weeks 1 to 6)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 41 (43.90%)
    58 / 132 (43.94%)
    72 / 132 (54.55%)
    19 / 65 (29.23%)
    45 / 129 (34.88%)
    18 / 75 (24.00%)
    4 / 17 (23.53%)
    9 / 39 (23.08%)
    10 / 60 (16.67%)
    25 / 85 (29.41%)
    Investigations
    Weight increased
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 132 (0.00%)
    0 / 132 (0.00%)
    3 / 65 (4.62%)
    3 / 129 (2.33%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    2 / 39 (5.13%)
    0 / 60 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    0
    3
    3
    0
    0
    2
    0
    1
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    0 / 41 (0.00%)
    8 / 132 (6.06%)
    12 / 132 (9.09%)
    4 / 65 (6.15%)
    2 / 129 (1.55%)
    1 / 75 (1.33%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    1 / 60 (1.67%)
    4 / 85 (4.71%)
         occurrences all number
    0
    9
    12
    4
    2
    1
    0
    0
    1
    4
    Dystonia
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 132 (3.03%)
    9 / 132 (6.82%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    2
    4
    10
    0
    0
    0
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    4 / 41 (9.76%)
    12 / 132 (9.09%)
    11 / 132 (8.33%)
    4 / 65 (6.15%)
    12 / 129 (9.30%)
    2 / 75 (2.67%)
    0 / 17 (0.00%)
    2 / 39 (5.13%)
    2 / 60 (3.33%)
    4 / 85 (4.71%)
         occurrences all number
    4
    12
    13
    4
    12
    2
    0
    2
    2
    4
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 41 (2.44%)
    7 / 132 (5.30%)
    3 / 132 (2.27%)
    1 / 65 (1.54%)
    5 / 129 (3.88%)
    2 / 75 (2.67%)
    1 / 17 (5.88%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    7
    4
    1
    6
    4
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    3 / 41 (7.32%)
    6 / 132 (4.55%)
    3 / 132 (2.27%)
    0 / 65 (0.00%)
    5 / 129 (3.88%)
    1 / 75 (1.33%)
    0 / 17 (0.00%)
    1 / 39 (2.56%)
    1 / 60 (1.67%)
    3 / 85 (3.53%)
         occurrences all number
    3
    6
    3
    0
    5
    3
    0
    1
    1
    3
    Nausea
         subjects affected / exposed
    2 / 41 (4.88%)
    21 / 132 (15.91%)
    25 / 132 (18.94%)
    6 / 65 (9.23%)
    6 / 129 (4.65%)
    3 / 75 (4.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    2 / 60 (3.33%)
    5 / 85 (5.88%)
         occurrences all number
    2
    25
    30
    11
    7
    6
    0
    0
    2
    5
    Toothache
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 132 (0.76%)
    0 / 132 (0.00%)
    2 / 65 (3.08%)
    1 / 129 (0.78%)
    1 / 75 (1.33%)
    0 / 17 (0.00%)
    1 / 39 (2.56%)
    1 / 60 (1.67%)
    0 / 85 (0.00%)
         occurrences all number
    3
    1
    0
    2
    1
    1
    0
    1
    1
    0
    Vomiting
         subjects affected / exposed
    4 / 41 (9.76%)
    16 / 132 (12.12%)
    18 / 132 (13.64%)
    1 / 65 (1.54%)
    7 / 129 (5.43%)
    4 / 75 (5.33%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    2 / 60 (3.33%)
    2 / 85 (2.35%)
         occurrences all number
    4
    21
    34
    4
    8
    5
    0
    0
    3
    2
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 132 (0.00%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    1 / 129 (0.78%)
    1 / 75 (1.33%)
    1 / 17 (5.88%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 132 (0.00%)
    0 / 132 (0.00%)
    1 / 65 (1.54%)
    1 / 129 (0.78%)
    0 / 75 (0.00%)
    1 / 17 (5.88%)
    0 / 39 (0.00%)
    1 / 60 (1.67%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    1
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 41 (9.76%)
    7 / 132 (5.30%)
    10 / 132 (7.58%)
    1 / 65 (1.54%)
    8 / 129 (6.20%)
    7 / 75 (9.33%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    2 / 60 (3.33%)
    4 / 85 (4.71%)
         occurrences all number
    4
    11
    13
    1
    8
    7
    0
    0
    2
    4
    Anxiety
         subjects affected / exposed
    2 / 41 (4.88%)
    8 / 132 (6.06%)
    13 / 132 (9.85%)
    4 / 65 (6.15%)
    8 / 129 (6.20%)
    2 / 75 (2.67%)
    0 / 17 (0.00%)
    1 / 39 (2.56%)
    1 / 60 (1.67%)
    4 / 85 (4.71%)
         occurrences all number
    2
    8
    13
    4
    12
    3
    0
    1
    1
    5
    Agitation
         subjects affected / exposed
    4 / 41 (9.76%)
    7 / 132 (5.30%)
    3 / 132 (2.27%)
    1 / 65 (1.54%)
    2 / 129 (1.55%)
    0 / 75 (0.00%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    5
    8
    3
    1
    2
    0
    0
    0
    0
    2
    Schizophrenia
         subjects affected / exposed
    2 / 41 (4.88%)
    6 / 132 (4.55%)
    11 / 132 (8.33%)
    2 / 65 (3.08%)
    7 / 129 (5.43%)
    1 / 75 (1.33%)
    0 / 17 (0.00%)
    0 / 39 (0.00%)
    1 / 60 (1.67%)
    6 / 85 (7.06%)
         occurrences all number
    2
    6
    11
    2
    7
    1
    0
    0
    1
    6
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 132 (0.00%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    1 / 17 (5.88%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 132 (0.00%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    0 / 75 (0.00%)
    1 / 17 (5.88%)
    0 / 39 (0.00%)
    0 / 60 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 132 (2.27%)
    3 / 132 (2.27%)
    1 / 65 (1.54%)
    3 / 129 (2.33%)
    1 / 75 (1.33%)
    0 / 17 (0.00%)
    2 / 39 (5.13%)
    0 / 60 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    3
    3
    1
    3
    1
    0
    2
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 132 (0.00%)
    0 / 132 (0.00%)
    0 / 65 (0.00%)
    0 / 129 (0.00%)
    1 / 75 (1.33%)
    0 / 17 (0.00%)
    2 / 39 (5.13%)
    1 / 60 (1.67%)
    0 / 85 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    2
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2020
    AM1: The primary purpose was to update the number of capsules for risperidone due to change in dose.
    24 Nov 2020
    AM2: The primary purpose was to update exclusion criterion per FDA feedback.
    17 Dec 2021
    AM3: The primary purpose was to increase flexibility in eligibility criteria due to enrollment challenges.
    16 Nov 2022
    AM4: The primary purpose was to end enrollment into the MK-8189 8 mg arm.

    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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