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    Clinical Trial Results:
    Cannabidiol as an add-on therapy in treatment-refractory psychotic disorders

    Summary
    EudraCT number
    2013-000240-26
    Trial protocol
    GB  
    Global end of trial date
    07 Aug 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Sep 2018
    First version publication date
    30 Sep 2018
    Other versions
    Summary report(s)
    FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    CBD_ADD_IN
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Paul Morrison, King's College London, 44 02078480057, paul.morrison@kcl.ac.uk
    Scientific contact
    Paul Morrison, King's College London, 44 02078480057, paul.morrison@kcl.ac.uk
    Sponsor organisation name
    South London & Maudsley NHS Foundation Trust
    Sponsor organisation address
    Bethlem Royal Hospital, Monks Orchard Road, Beckenham, United Kingdom, BR3 3BX
    Public contact
    Paul Morrison, South London & Maudsley NHS Foundation Trust, 44 02078480057, paul.morrison@kcl.ac.uk
    Scientific contact
    Paul Morrison, South London & Maudsley NHS Foundation Trust, 44 02078480057, paul.morrison@kcl.ac.uk
    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
    07 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine whether the addition of the molecule Cannabidiol (CBD) leads to improvement in the severity of core psychotic symptom, in patients experiencing their first psychotic episode who have failed to recover despite treatment with at least one standard anti-psychotic drug.
    Protection of trial subjects
    Subjects would continue to be seen by Community Mental Health team.
    Background therapy
    Participants will already be prescribed an oral antipsychotic medication (a dopamine-based pharmaceutical) at the time of entry into the study. In the majority of cases, this will be a 2nd generation drug (e.g. amisulpride, risperidone, olanzapine, quetiapine) in line with treatment guidelines in schizophrenia and local prescribing practice. CBD will be added to the existing dopamine-based treatment regime
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    25 Sep 2014
    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: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants recruited from the South London & Maudsley NHS Foundation Trust in the UK between July 2014 and August 2015.

    Pre-assignment
    Screening details
    Screening visit to include Psychopathology assessments, metabolic assessments, MRI imaging, vital signs including body weight and urine drug screen.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Full study
    Arm description
    An open-label, exploratory therapeutic trial of the molecule Cannabidiol in treatment refractory 1st episode psychosis (n=20), focusing on core psychological and metabolic outcomes. Cannabidiol will be added to an existing treatment regime (based on dopamine receptor antagonists) for 6-weeks duration. Clinical data will be collected over the duration of the trial, at 0, 2, 4 and 6 week time points.
    Arm type
    Experimental

    Investigational medicinal product name
    Cannabidiol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Flexible titrated oral dosing as 100mg capsules x n/day (where n =1-8), Range: 200-800mg/day total, in 1-2 divided doses. Initial starting dose = 4 capsules/day. Flexible Dosing: If participants experience the 400mg/d dose as being too sedating, the dose will be reduced to 200mg/d. Blood pressure will be monitored before and after the first dosing of the IMP. If after two weeks, the participant tolerates the 400mg/d dose, the dose will be increased to 600mg/d. If after a further two weeks, the participant tolerates the 600mg/d dose, the dose will be increased to 800mg/d.

    Number of subjects in period 1
    Full study
    Started
    5
    Completed
    3
    Not completed
    2
         Physician decision
    2

    Baseline characteristics

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

    Reporting group values
    Overall Trial Total
    Number of subjects
    5 5
    Age categorical
    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)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
        Adults Aged 18-60 years
    5 5
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    5 5

    End points

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    End points reporting groups
    Reporting group title
    Full study
    Reporting group description
    An open-label, exploratory therapeutic trial of the molecule Cannabidiol in treatment refractory 1st episode psychosis (n=20), focusing on core psychological and metabolic outcomes. Cannabidiol will be added to an existing treatment regime (based on dopamine receptor antagonists) for 6-weeks duration. Clinical data will be collected over the duration of the trial, at 0, 2, 4 and 6 week time points.

    Primary: Primary Endpoint

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    End point title
    Primary Endpoint [1]
    End point description
    Scores on core psychotic symptoms and functioning, as measured by the following scales: - The Positive & Negative Syndrome Scale, PANSS22 (videotaped interview). - The Global Assessment of Functioning Scale, GAF - The Community Assessment of Psychotic Experiences, CAPE-4222 - The Montgomery-Asberg Depression Rating Scale, MAD RS - The Clinical Global Impression scale, CGI.
    End point type
    Primary
    End point timeframe
    Until end of trial participation for each participant
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Insufficient data for analysis
    End point values
    Full study
    Number of subjects analysed
    0 [2]
    Units: Interviews and questionaires
        number (not applicable)
    Notes
    [2] - Insufficient data was obtained for analysis & trial prematurely terminated. PK sampling not done
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Continuous
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Whole Trial
    Reporting group description
    -

    Serious adverse events
    Whole Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Whole Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    Gastrointestinal disorders
    Flatulence
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    stomach cramps
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Psychiatric disorders
    Intoxication
    Additional description: Dropped out following the 1st study visit due to concerns of intoxicating effects of IMP one day into the trial, after 400mg bd dose. Patient was very anxious and the perceived intoxicating effects of IMP may have been due to psychosomatic concerns
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Psychosis
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Mar 2014
    1) An additional secondary objective: “To determine whether measures of brain activity using magnetic resonance imaging can predict response to CBD, and whether these measures change with response to CBD” 2) The addition of the following endpoints: “Brain glutamate measures with 1H-MRS, blood flow using ASL and BOLD response with fMRI imaging methods” 3) A modification to the following inclusion criteria: Aged 18-6035 (inclusive) meeting DSM IV criteria for schizophrenia within the first 3 years of presentation to psychiatric services. 4) An update to the Investigator Brochure (Edition 6 August 2013) in the form of a Development Core Safety Information (DSCI) detailing a revision to section 7.6 (Safety), which will be included as appendix 3 to the current IB.
    27 Mar 2015
    The amendment consists of the removal of one of the exclusion criteria. It is expected this will result in an increase in patient recruitment, and an, albeit slight, change in patient population studied, and is therefore deemed as a substantial amendment for the MHRA. The following criteria was removed; Concomitant anti-depressant/anti-convulsant treatment for 2-months prior to study entry.

    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.
    July 2015 the IMP expired. The IMP was sent for analysis and was found to be unstable so a shelf-life so a shelf-life extension was not granted. Additionally the Science had moved on by this stage. Insufficient data had been obtained for analysis.
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