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    Clinical Trial Results:
    CANGLIA: Endocannabinoid control of microglia activation as a new therapeutic target in the treatment of schizophrenia

    Summary
    EudraCT number
    		 2016-003529-41
    Trial protocol
    		 NL  
    Global end of trial date
    31 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2021
    First version publication date
    03 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABR58805
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02932605
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Center Utrecht
    Sponsor organisation address
    Heidelberglaan 100, Utrecht, Netherlands, 3584CX
    Public contact
    Department of Psychiatry, University Medical Center Utrecht, 0031 887556369, m.bossong@umcutrecht.nl
    Scientific contact
    Department of Psychiatry, University Medical Center Utrecht, 0031 887556369, m.bossong@umcutrecht.nl
    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
    03 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare brain function and metabolism as measured with Magnetic Resonance Imaging (MRI) between recent-onset patients with a psychotic disorder who are randomised to CBD and those randomised to placebo.
    Protection of trial subjects
    Potential participants were extensively screened before enrolment, including blood and urine tests examining haematology, chemistry, drug use and pregnancy. For blood sampling and MRI standard procedures were followed, which were performed by appropriately trained staff to minimise risks. During study days, participants could have a break whenever needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Nov 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
    Netherlands: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    2
    Adults (18-64 years)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited in the Netherlands, between August 2018 and December 2019.

    Pre-assignment
    Screening details
    		 In total, 48 recent-onset patients with a psychotic disorder (within five years after diagnosis) signed informed consent and were included in the study. 32 of them were deemed eligible to participate, and were randomised to either placebo or CBD treatment. Potential participants were screened for in- and exclusion criteria.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cannabidiol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cannabidiol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    study medication was given as three 200 mg capsules taken once daily.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Study medication was given as three capsules taken once daily.

    Number of subjects in period 1
    		Cannabidiol Placebo
    Started
    16
    16
    Completed
    16
    16
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cannabidiol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cannabidiol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    study medication was given as three 200 mg capsules taken once daily.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Study medication was given as three capsules taken once daily.

    Number of subjects in period 2 [1]
    		Cannabidiol Placebo
    Started
    16
    15
    Completed
    16
    15
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One patient (in the placebo group) withdrew consent during treatment, i.e. in between baseline and follow-up.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 32 32
    Age categorical
    Patients were between 16 and 39 years old
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 2 2
        Adults (18-64 years)
    		 30 30
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 26 ( 6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 22 22

    End points

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    End points reporting groups
    Reporting group title
    Cannabidiol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Cannabidiol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Prefrontal metabolite concentrations

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    End point title
    		 Prefrontal metabolite concentrations
    End point description
    Prefrontal metabolites measured include GABA,Glx (combined measure of glutamine and glutamate), gluthation
    End point type
    Primary
    End point timeframe
    Prefrontal metabolite concentrations were measured at baseline and at follow-up
    End point values
    		 Cannabidiol Placebo Cannabidiol Placebo
    Number of subjects analysed
    16
    14
    16
    14
    Units: arbitrary units
    arithmetic mean (standard deviation)
        GABA
    1.09 ( 0.11 )
    1.12 ( 0.1 )
    1.14 ( 0.16 )
    1.17 ( 0.14 )
        Glx
    3.47 ( 0.34 )
    3.39 ( 0.3 )
    3.56 ( 0.31 )
    3.56 ( 0.32 )
        Glutathion
    0.94 ( 0.11 )
    0.93 ( 0.1 )
    0.92 ( 0.15 )
    0.87 ( 0.13 )
    Statistical analysis title
    		 ANOVA
    Comparison groups
    Placebo v Cannabidiol v Cannabidiol v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomisation to either treatment arm until the end of the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 no dictionary used
    Dictionary version
    x
    Reporting groups
    Reporting group title
    Cannabidiol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Cannabidiol Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cannabidiol Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 16 (100.00%)
    12 / 16 (75.00%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    7 / 16 (43.75%)
    6 / 16 (37.50%)
         occurrences all number
    7
    6
    General disorders and administration site conditions
    Injury
         subjects affected / exposed
    4 / 16 (25.00%)
    0 / 16 (0.00%)
         occurrences all number
    4
    0
    Infection or disease
         subjects affected / exposed
    4 / 16 (25.00%)
    2 / 16 (12.50%)
         occurrences all number
    4
    2
    MRI incidental finding
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 16 (50.00%)
    1 / 16 (6.25%)
         occurrences all number
    8
    1
    Abdominal pain
         subjects affected / exposed
    4 / 16 (25.00%)
    1 / 16 (6.25%)
         occurrences all number
    4
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    Emotional disorder
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    Psychotic symptoms
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Please note that this is all preliminary data and that data analyis is ongoing.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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