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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Subjects with Stable Schizophrenia

    Summary
    EudraCT number
    		 2017-001084-20
    Trial protocol
    		 GB  
    Global end of trial date
    06 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Nov 2020
    First version publication date
    22 Nov 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TAK-041-2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03319953
    WHO universal trial number (UTN)
    		 U1111-1191-6915
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    61 Aldwych, London, United Kingdom, WC2B 4AE
    Public contact
    Medical Director, Takeda, 001 +18778253327, trialdisclosures@takeda.com
    Scientific contact
    Medical Director, Takeda, 001 +18778253327, trialdisclosures@takeda.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 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to determine whether motivation/reward deficits observed in schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia is improved by add-on TAK-041 administration to antipsychotics in participants with stable schizophrenia.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2017
    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: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    23
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants took part in the study at single investigative sites in United Kingdom from 21 December 2017 to 06 November 2019.

    Pre-assignment
    Screening details
    		 Participants with stable schizophrenia were enrolled to receive TAK-041 or placebo in this study in crossover pattern along with the add on to antipsychotics to assess the proof of activity.

    Period 1
    Period 1 title
    Period 1 (Day 1 to 14)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics
    Arm description
    		 TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TAK-041 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Arm title
    		 Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics
    Arm description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TAK-041 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Arm title
    		 Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics
    Arm description
    		 TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TAK-041 160 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Arm title
    		 Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
    Arm description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TAK-041 160 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Number of subjects in period 1
    		Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
    Started
    3
    4
    9
    7
    Completed
    3
    4
    9
    7
    Period 2
    Period 2 title
    Washout Period (Day 15 to 49)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics
    Arm description
    		 TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Investigational medicinal product name
    TAK-041 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Arm title
    		 Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics
    Arm description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TAK-041 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Arm title
    		 Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics
    Arm description
    		 TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TAK-041 160 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Arm title
    		 Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
    Arm description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TAK-041 160 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Number of subjects in period 2
    		Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
    Started
    3
    4
    9
    7
    Completed
    3
    4
    9
    7
    Period 3
    Period 3 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics
    Arm description
    		 TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Investigational medicinal product name
    TAK-041 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Arm title
    		 Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics
    Arm description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Investigational medicinal product name
    TAK-041 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Arm title
    		 Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics
    Arm description
    		 TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TAK-041 160 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Arm title
    		 Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
    Arm description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 placebo-matching suspension

    Investigational medicinal product name
    TAK-041 160 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-041 suspension

    Number of subjects in period 3
    		Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
    Started
    3
    4
    9
    7
    Completed
    2
    4
    8
    6
    Not completed
    1
    0
    1
    1
         Consent withdrawn by subject
    1
    -
    -
    -
         Reason not Specified
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics
    Reporting group description
    		 TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics
    Reporting group description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics
    Reporting group description
    		 TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
    Reporting group description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group values
    		 Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics Total
    Number of subjects
    		 3 4 9 7 23
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.0 ± 16.5 39.3 ± 16.1 46.8 ± 12.1 43.4 ± 9.6 -
    Sex: Female, Male
    Units: participants
        Female
    		 0 2 2 2 6
        Male
    		 3 2 7 5 17
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 0
        Not Hispanic or Latino
    		 3 4 9 7 23
        Unknown or Not Reported
    		 0 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 0 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 3 3 4 6 16
        White
    		 0 1 4 0 5
        More than one race
    		 0 0 0 1 1
        Unknown or Not Reported
    		 0 0 0 0 0
    Region of Enrollment
    Units: Subjects
        United Kingdom
    		 3 4 9 7 23
    Body Mass Index (BMI)
    Body Mass Index (BMI) was calculated as weight (kg)/[height (m)^2].
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 30.7 ± 3.1 26.3 ± 3.8 32.3 ± 7.1 30.0 ± 4.7 -
    Subject analysis sets

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    TAK-041 40 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    TAK-041 160 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    TAK-041 40 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    TAK-041 160 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis sets values
    		 Placebo TAK-041 40 mg TAK-041 160 mg Placebo TAK-041 40 mg TAK-041 160 mg
    Number of subjects
    21
    7
    15
    20
    6
    13
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    0.23 ± 0.396
    0.23 ± 0.202
    0.03 ± 0.458
    Sex: Female, Male
    Units: participants
        Female
        Male
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
        Not Hispanic or Latino
        Unknown or Not Reported
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
        Asian
        Native Hawaiian or Other Pacific Islander
        Black or African American
        White
        More than one race
        Unknown or Not Reported
    Region of Enrollment
    Units: Subjects
        United Kingdom
    Body Mass Index (BMI)
    Body Mass Index (BMI) was calculated as weight (kg)/[height (m)^2].
    Units: kg/m^2
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±

    End points

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    End points reporting groups
    Reporting group title
    Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics
    Reporting group description
    		 TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics
    Reporting group description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics
    Reporting group description
    		 TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
    Reporting group description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Reporting group title
    Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics
    Reporting group description
    		 TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics
    Reporting group description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics
    Reporting group description
    		 TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
    Reporting group description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.
    Reporting group title
    Treatment Sequence 1: TAK-041 40 mg/Placebo + Antipsychotics
    Reporting group description
    		 TAK-041 40 milligram (mg), suspension, orally on Day 1 of Treatment Period 1, followed by 35 days wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 2: Placebo/TAK-041 40 mg + Antipsychotics
    Reporting group description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 3: TAK-041 160 mg/Placebo + Antipsychotics
    Reporting group description
    		 TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    Treatment Sequence 4: Placebo/TAK-041 160 mg + Antipsychotics
    Reporting group description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1, followed by 35 days Wash-out Period, followed by TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 2. All participants received stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    TAK-041 40 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    TAK-041 160 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    TAK-041 40 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Subject analysis set title
    TAK-041 160 mg
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Primary: Change from Placebo in the Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score at Second Testing After TAK-041 Administration

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    End point title
    		 Change from Placebo in the Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score at Second Testing After TAK-041 Administration
    End point description
    BACS is a reliable and sensitive measure of cognitive function in schizophrenia. The BACS consisted of items across 6 subtests: Verbal Memory, Digit Sequencing, Token Motor, Verbal Fluency, Symbol Coding, and Tower of London. A BACS composite score ranges up to maximum of 50 with a standard deviation of 20. Higher values (positive changes from placebo) indicate better performance. Bayesian normal linear model was used for analysis. Pharmacodynamic (PD) Analysis Set included all participants who received at least 1 dose of study drug and had at least 1 evaluable primary or exploratory PD measurement. Number analyzed is the number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Baseline (Day -1) and Day 14
    End point values
    		 Placebo TAK-041 40 mg TAK-041 160 mg
    Number of subjects analysed
    21
    7
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=21,7,15)
    29.72 ± 12.867
    27.35 ± 12.753
    27.89 ± 8.214
        Day 14 (n=21,7,14)
    2.28 ± 6.963
    5.35 ± 6.944
    1.31 ± 5.618
    Statistical analysis title
    		 TAK-041 160 mg Vs Placebo
    Comparison groups
    Placebo v TAK-041 40 mg
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2079 [1]
    Method
    		 Bayesian Normal Linear Model
    Confidence interval
    Notes
    [1] - Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo >2.0.
    Statistical analysis title
    		 TAK-041 160 mg Vs Placebo
    Comparison groups
    Placebo v TAK-041 160 mg
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0633 [2]
    Method
    		 Bayesian Normal Linear Model
    Confidence interval
    Notes
    [2] - Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo >2.0.

    Primary: Blood-Oxygen-Level-Dependent (BOLD) Signal in the Average Ventral Striatum (VS) Region of Interest (ROI) Activation in the Monetary Incentive Delay (MID) Reward Task at First Testing After TAK-041 Administration

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    End point title
    		 Blood-Oxygen-Level-Dependent (BOLD) Signal in the Average Ventral Striatum (VS) Region of Interest (ROI) Activation in the Monetary Incentive Delay (MID) Reward Task at First Testing After TAK-041 Administration
    End point description
    BOLD Functional magnetic resonance imaging (fMRI) changes in the BOLD - signal, which changes in response to neural activity. Baseline fMRI measurements will be followed by rewarded delayed response Working Memory (WM) task measurements in which participants are required to remember the spatial location of a target stimulus (a dot) relative to a fixation cross. Participants are given feedback indicating success or failure. Bayesian normal linear model was used for analysis. PD Analysis Set included all participants who received at least 1 dose of study drug and had at least 1 evaluable primary or exploratory PD measurement. Overall number of participants analyzed is the number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Day 1
    End point values
    		 Placebo TAK-041 40 mg TAK-041 160 mg
    Number of subjects analysed
    20
    6
    13
    Units: BOLD signal
        arithmetic mean (standard deviation)
    0.23 ± 0.396
    0.23 ± 0.202
    0.03 ± 0.458
    Statistical analysis title
    		 TAK-041 40 mg Vs Placebo
    Comparison groups
    Placebo v TAK-041 40 mg
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1706 [3]
    Method
    		 Bayesian Normal Linear Model
    Confidence interval
    Notes
    [3] - Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo >0.09.
    Statistical analysis title
    		 TAK-041 160 mg Vs Placebo
    Comparison groups
    Placebo v TAK-041 160 mg
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0373 [4]
    Method
    		 Bayesian Normal Linear Model
    Confidence interval
    Notes
    [4] - Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo >0.09.

    Secondary: Percentage of Participants who Experience at least one Treatment Emergent Adverse Event (TEAE)

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    End point title
    		 Percentage of Participants who Experience at least one Treatment Emergent Adverse Event (TEAE)
    End point description
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
    End point values
    		 Placebo TAK-041 40 mg TAK-041 160 mg
    Number of subjects analysed
    21
    7
    15
    Units: percentage of participants
        number (not applicable)
    57.1
    71.4
    53.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at least Once Post Dose

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    End point title
    		 Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at least Once Post Dose
    End point description
    Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as: alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN),albumin<25 g/L*lower limit of normal(LLN), alkaline phosphatase >3.0 U/L*ULN, aspartate aminotransferase >3.0 U/L*ULN, bilirubin >34.2 umol/L*ULN, calcium <1.75 mmol/L, >2.88 mmol/L, chloride <75 mmol/L, >126 mmol/L, creatinine >177umol/L, gamma glutamyl transferase >3 U/L*ULN, glucose <2.8 mmol/L, >19.4 mmol/L, potassium<3 mmol/L, >6 mmol/L, sodium <130 mmol/L, >150 mmol/L,Urea <130 mmol/L, erythrocytes <0.8*LLN >1.2*ULN, hematocrit <0.8*LLN, >1.2*ULN, hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN, leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN, platelets <75(10^9/L), >600(10^9/L). Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
    End point values
    		 Placebo TAK-041 40 mg TAK-041 160 mg
    Number of subjects analysed
    21
    7
    15
    Units: percentage of participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements At Least Once Post Dose

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    End point title
    		 Percentage of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements At Least Once Post Dose
    End point description
    Vital signs included oral body temperature measurement, supine and standing blood pressure, respiration rate, and pulse. Pulse and blood pressure were measured after 5 minutes supine and again at 1 and 3 minutes after standing. The markedly abnormal value (MAV) criteria for vital signs included systolic blood pressure < 85 mmHg, > 180 mmHg; diastolic blood pressure < 50 mmHg, > 110 mmHg; pulse < 50 beats/min, > 120 beats/min; temperature < 35.6 C > 37.7 C. Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. Categories with at least one participant are reported.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
    End point values
    		 Placebo TAK-041 40 mg TAK-041 160 mg
    Number of subjects analysed
    21
    7
    15
    Units: percentage of participants
    number (not applicable)
        <35.6 C
    0
    0
    6.7
        >37.7 C
    4.8
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) at Least Once Post Dose

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    End point title
    		 Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) at Least Once Post Dose
    End point description
    The markedly abnormal value (MAV) criteria for 12-lead ECG parameters included ECG Mean Heart Rate < 50 beats/min, > 120 beats/min; PR Interval, Aggregate <= 80 msec, >= 200 msec; QRS Duration, Aggregate <= 80 msec, >= 180 msec; QTcB Interval, Aggregate <= 300 msec, >= 500 msec OR (>= 30 msec change from baseline and >= 450 msec); QTcF Interval, Aggregate <= 300 msec, >= 500 msec OR (>= 30 msec change from baseline and >= 450 msec). Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug. Categories with at least one participant are reported. Number analyzed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
    End point values
    		 Placebo TAK-041 40 mg TAK-041 160 mg
    Number of subjects analysed
    21
    7
    15
    Units: percentage of participants
    number (not applicable)
        ECG Mean Heart Rate: <50 beats per minute
    0
    0
    6.7
        PR Interval: >=200 milliseconds
    10.5
    20.0
    13.3
        QRS Duration: <=80 milliseconds
    36.8
    20.0
    33.3
    No statistical analyses for this end point

    Secondary: Number of Participants with Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Number of Participants with Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
    End point description
    Treatment-emergent suicidal ideation (SI)/suicidal behavior (SB) compared to baseline was measured by increase in SI (1-5 on C-SSRS)/SB category (6-10 on the C-SSRS) during treatment from maximum SI/SB at baseline, or any SI/SB during treatment if there is none at baseline. C-SSRS is used to assesses if participant experienced SI (1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active SI with any methods (not plan) without intent to act; 4: active SI with some intent to act, without specific plan; 5: active SI with specific plan and intent) and SB (6: actual attempt; 7: interrupted attempt; 8: aborted attempt; 9: preparatory acts or behavior; 10: suicidal behavior). Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug. Only categories with at least one participant are reported. Number analyzed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Days 14, 35 and 77
    End point values
    		 Placebo TAK-041 40 mg TAK-041 160 mg
    Number of subjects analysed
    21
    7
    15
    Units: participants
        SI-Wish to be Dead, Day -1
    3
    0
    1
        SI-Wish to be Dead, Day 14
    1
    0
    0
        SI-Wish to be Dead, Day 77
    1
    0
    1
        SB-Non-suicidal Self-injurious Behaviour, Day 77
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug up to 77 days after last dose of study drug (Up to Day 154)
    Adverse event reporting additional description
    At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. Safety analysis set: all participants who were enrolled and received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 TAK-041 placebo-matching, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    TAK-041 40 mg
    Reporting group description
    		 TAK-041 40 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Reporting group title
    TAK-041 160 mg
    Reporting group description
    		 TAK-041 160 mg, suspension, orally on Day 1 of Treatment Period 1 or 2. All participants took a stable dose of antipsychotics as per standard of care throughout the duration of the Treatment Period.

    Serious adverse events
    		 Placebo TAK-041 40 mg TAK-041 160 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo TAK-041 40 mg TAK-041 160 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 21 (57.14%)
    5 / 7 (71.43%)
    8 / 15 (53.33%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    2
    0
    1
    Chest Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Catheter Site Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Social circumstances
    Pregnancy Of Partner
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 7 (28.57%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Nasal Congestion
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Panic Attack
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Paranoia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Schizophrenia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Lymphocyte Count Decreased
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Muscle Strain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Procedural Headache
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 7 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    1
    Somnolence
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Syncope
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dry Skin
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Back Pain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 7 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Myalgia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    Muscle Spasms
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Neck Pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    3
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 7 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 7 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 7 (14.29%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jul 2017
    Amendment 01: •Added a serum pregnancy test at Day 49 for each treatment Period.
    07 Sep 2017
    Amendment 02: • Removed 20 mg TAK-041 arm from both Periods •Added rationale for washout interval •Revised the primary hypotheses, progressive disease (PD) assessments, objectives, endpoints •Revised inclusion and exclusion criteria, and excluded medications •Revised the interim analysis (IA) plan •Revised plasma pharmacokinetic (PK) sampling times •Updated the determination of sample size.
    02 Apr 2018
    Amendment 03: •Decreased the washout period between dosing in Period 1 and Period 2 •Added a coprimary objective, hypothesis, and endpoint related to cognitive impairment associated with schizophrenia •Added participants on first generation antipsychotics, and excluded specific antipsychotics and revised inclusion criteria related to antipsychotic treatment •Added that up to 4 sites could be used •Updated laboratory assessments, inclusion and exclusion criteria •Revised criteria for discontinuation or withdrawal of a participant.
    10 Aug 2018
    Amendment 4: •Modified rationale and potential range for study drug dose level •Revised exclusion criteria for abnormal laboratory values •Revised exclusion criterion for magnetic resonance imaging (MRI) contraindication before imaging assessments •Introduced randomization stratification by site.

    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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