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    Clinical Trial Results:
    A double-blind, randomised, placebo-controlled, parallel group study of GWP42003 as adjunctive therapy in the first line treatment of schizophrenia or related psychotic disorder

    Summary
    EudraCT number
    		 2013-000212-22
    Trial protocol
    		 GB   PL   RO  
    Global end of trial date
    08 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2019
    First version publication date
    09 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GWAP1241
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02006628
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GW Research Ltd
    Sponsor organisation address
    Sovereign House, Vision Park, Chivers Way, Histon, Cambridge, United Kingdom, CB24 9BZ
    Public contact
    Alternate contact: medinfo@greenwichbiosciences.com, GW Research Ltd, +44 1223 238170, medinfo@gwpharm.com
    Scientific contact
    Alternate contact: medinfo@greenwichbiosciences.com, GW Research Ltd, +44 1223 238170, medinfo@gwpharm.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
    08 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of GWP42003 as an adjunctive therapy to first line treatment in alleviating symptoms of schizophrenia or related psychotic disorder compared with placebo on the following non-comprehensive list of assessments: - Positive and Negative Syndrome Scale (PANSS) total score - PANSS P, N, & G scores - Scale for the Assessment of Negative Symptoms (SANS) score - Clinical assessment of (change in) mental state (CGI-S & CGI-I, respectively) - Brief Assessment of Cognition in Schizophrenia (BACS) - Assess safety & tolerability of GWP42003 as adjunctive therapy
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted. No study procedures were performed on study candidates until written consent had been obtained from the participant. The informed consent form, protocol, and amendments for this study were submitted to and approved by the institutional review board or independent ethics committee at each participating study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Feb 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
    Poland: 37
    Country: Number of subjects enrolled
    Romania: 40
    Country: Number of subjects enrolled
    United Kingdom: 11
    Worldwide total number of subjects
    88
    EEA total number of subjects
    88
    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)
    88
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This was a multi-center, double-blind, randomised, placebo-controlled, parallel group study of GWP42003 1000 milligrams (mg)/day compared to placebo; 6-week treatment study period followed by a 2-week follow-up period. Eligible participants entered the study at a Screening and Randomisation Visit (Day 1), where eligibility was established.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GWP42003 1000 mg/day
    Arm description
    		 Participants received GWP42003 (100 mg/mL), 5 mL twice daily (BID) administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GWP42003
    Investigational medicinal product code
    Other name
    Cannabidiol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    GWP42003 was presented as an oral solution containing 100 mg/mL cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener and strawberry flavoring.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo (0 mL cannabidiol [CBD]), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo control
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo (0 mg/mL CBD) dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener and strawberry flavoring.

    Number of subjects in period 1
    		GWP42003 1000 mg/day Placebo
    Started
    43
    45
    Received at Least 1 Dose of Study Drug
    43
    45
    Completed
    40
    43
    Not completed
    3
    2
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GWP42003 1000 mg/day
    Reporting group description
    		 Participants received GWP42003 (100 mg/mL), 5 mL twice daily (BID) administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (0 mL cannabidiol [CBD]), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.

    Reporting group values
    		 GWP42003 1000 mg/day Placebo Total
    Number of subjects
    		 43 45 88
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 43 45 88
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.9 ± 12.49 40.8 ± 11.00 -
    Gender categorical
    Units: Subjects
        Female
    		 15 22 37
        Male
    		 28 23 51

    End points

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    End points reporting groups
    Reporting group title
    GWP42003 1000 mg/day
    Reporting group description
    		 Participants received GWP42003 (100 mg/mL), 5 mL twice daily (BID) administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (0 mL cannabidiol [CBD]), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.

    Primary: Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score

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    End point title
    		 Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score
    End point description
    The PANSS was a 30-item medical scale completed by a trained rater that assessed the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. The PANSS Total score was derived from the sum of the 30 items, which were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total score is the summed total for each of the PANSS positive symptom ('P'), negative symptom ('N'), general psychopathology symptom ('G') scores and could range from 30 to 210 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 43
    End point values
    		 GWP42003 1000 mg/day Placebo
    Number of subjects analysed
    42
    44
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline Score
    79.3 ± 12.45
    80.6 ± 14.90
        End of Treatment score
    68.1 ± 14.79
    71.9 ± 15.49
        Change from baseline
    -11.2 ± 7.87
    -8.8 ± 8.87
    Statistical analysis title
    		 GWP42003 1000 mg/day, Placebo
    Comparison groups
    Placebo v GWP42003 1000 mg/day
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1332
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference (GWP42003-placebo)
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 0.9

    Primary: Change From Baseline To The End Of Treatment (Day 43) In PANSS ‘P’ Score

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    End point title
    		 Change From Baseline To The End Of Treatment (Day 43) In PANSS ‘P’ Score
    End point description
    The PANSS ‘P’ scale measured the severity of positive symptoms, including delusions, conceptual disorganisation, hallucinations, hyperactivity, grandiosity, suspiciousness/persecution, and hostility. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total ‘P’ score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 43
    End point values
    		 GWP42003 1000 mg/day Placebo
    Number of subjects analysed
    42
    44
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline score
    18.0 ± 3.89
    17.5 ± 3.29
        End of Treatment score
    14.8 ± 4.01
    15.7 ± 3.73
        Change from Baseline
    -3.2 ± 2.60
    -1.7 ± 2.76
    Statistical analysis title
    		 GWP42003 1000 mg/day, Placebo
    Comparison groups
    Placebo v GWP42003 1000 mg/day
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0188
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference (GWP42003-placebo)
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -0.2

    Primary: Change From Baseline To The End Of Treatment (Day 43) In PANSS ‘N’ Score

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    End point title
    		 Change From Baseline To The End Of Treatment (Day 43) In PANSS ‘N’ Score
    End point description
    The PANSS ‘N’ scale measured the severity of negative symptoms, including blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total ‘N’ score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 43
    End point values
    		 GWP42003 1000 mg/day Placebo
    Number of subjects analysed
    42
    44
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline score
    22.6 ± 5.04
    23.4 ± 5.11
        End of Treatment score
    19.9 ± 5.32
    20.5 ± 5.22
        Change from Baseline
    -2.7 ± 3.55
    -2.9 ± 3.06
    Statistical analysis title
    		 GWP42003 1000 mg/day, Placebo
    Comparison groups
    GWP42003 1000 mg/day v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9647
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference (GWP42003-placebo)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.4

    Primary: Change From Baseline To The End Of Treatment (Day 43) In PANSS ‘G’ Score

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    End point title
    		 Change From Baseline To The End Of Treatment (Day 43) In PANSS ‘G’ Score
    End point description
    The PANSS ‘G’ scale measured the severity of general psychopathology symptoms, including somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgement and insight, disturbance of violation, poor impulse control, preoccupation, and active social avoidance. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total ‘G’ score could range from 16 to 112 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 43
    End point values
    		 GWP42003 1000 mg/day Placebo
    Number of subjects analysed
    42
    44
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline score
    38.7 ± 6.71
    39.7 ± 8.95
        End of Treatment score
    33.4 ± 7.69
    35.6 ± 9.04
        Change from Baseline
    -5.3 ± 4.34
    -4.1 ± 4.78
    Statistical analysis title
    		 GWP42003 1000 mg/day, Placebo
    Comparison groups
    GWP42003 1000 mg/day v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1963
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference (GWP42003-placebo)
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 0.7

    Primary: Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)

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    End point title
    		 Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)
    End point description
    The SANS assessed 5 symptom complexes to obtain clinical ratings of negative symptoms in participants with schizophrenia or related psychotic disorder. Symptom complexes were affective blunting, alogia (impoverished thinking), avolition/apathy, anhedonia/asociality, and disturbance of attention. Assessments were conducted on a 6-point scale (0 = not at all; 5 = severe). The total score could range from 0 to 125 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 43
    End point values
    		 GWP42003 1000 mg/day Placebo
    Number of subjects analysed
    42
    44
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline score
    52.8 ± 17.10
    55.3 ± 16.24
        End of Treatment score
    43.6 ± 16.54
    48.4 ± 15.75
        Change from Baseline
    -9.1 ± 13.09
    -6.3 ± 8.54
    Statistical analysis title
    		 GWP42003 1000 mg/day, Placebo
    Comparison groups
    GWP42003 1000 mg/day v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1167
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference (GWP42003-placebo)
    Point estimate
    -3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.9
         upper limit
    		 0.9

    Primary: Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)

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    End point title
    		 Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)
    End point description
    The CGI-S was a 7-point scale that required the clinician to rate the severity of a participant’s illness at the time of assessment, relative to the clinician’s past experience of participants who had the same diagnosis. Considering total clinical experience, participants were assessed on severity of mental illness at the time of rating on the following scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. Lower scores equated to milder severity of symptoms, that is, closer to psychologically normal.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 43
    End point values
    		 GWP42003 1000 mg/day Placebo
    Number of subjects analysed
    42
    44
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline score
    4.0 ± 0.70
    4.0 ± 0.65
        End of Treatment score
    3.5 ± 1.09
    3.8 ± 0.78
        Change from Baseline
    -0.5 ± 0.74
    -0.3 ± 0.49
    Statistical analysis title
    		 GWP42003 1000 mg/day, Placebo
    Comparison groups
    GWP42003 1000 mg/day v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0443
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference (GWP42003-placebo)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0

    Primary: Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)

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    End point title
    		 Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)
    End point description
    The CGI-I was a 7-point scale that required the clinician to assess how much a participant’s illness had improved or worsened relative the first assessment at the beginning of the intervention. This was rated on the following scale: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. Lower scores equated to improvement of symptoms.
    End point type
    Primary
    End point timeframe
    Day 8 through Day 43
    End point values
    		 GWP42003 1000 mg/day Placebo
    Number of subjects analysed
    42
    44
    Units: score on a scale
    arithmetic mean (standard deviation)
        Day 8 score
    3.6 ± 0.50
    3.8 ± 0.56
        End of Treatment score
    2.9 ± 0.89
    3.4 ± 0.87
    Statistical analysis title
    		 GWP42003 1000 mg/day, Placebo
    Comparison groups
    GWP42003 1000 mg/day v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0182
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference (GWP42003-placebo)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.1

    Primary: Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score

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    End point title
    		 Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score
    End point description
    The BACS was an instrument used to assess the aspects of cognition found to be most impaired and most strongly correlated with outcome in participants with schizophrenia or related psychotic disorder. The BACS consisted of 6 domains: verbal memory (score range 0 to 75), working memory (score range 0 to 28), motor speed (score range 0 to 100), verbal fluency (score > 0), attention and speed of information processing (score range 0 to 110), and executive functions (score range 0 to 22). A score was obtained for each domain and a composite summary score was also calculated as the average of the scores from the 6 domains. An increase in score was indicative of an improvement in cognition.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 43
    End point values
    		 GWP42003 1000 mg/day Placebo
    Number of subjects analysed
    42
    44
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline score
    32.21 ± 6.042
    32.91 ± 7.158
        End of Treatment score
    35.73 ± 6.981
    35.05 ± 7.310
        Change from Baseline
    3.48 ± 3.031
    2.14 ± 3.442
    Statistical analysis title
    		 GWP42003 1000 mg/day, Placebo
    Comparison groups
    GWP42003 1000 mg/day v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0677
    Method
    		 ANCOVA
    Parameter type
    		 Treatment difference (GWP42003-placebo)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 2.72

    Primary: Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)

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    End point title
    		 Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)
    End point description
    The percentage of PANSS treatment responders, defined as participants with ≥20% improvement in PANSS total score between baseline and End of Treatment (Day 43), is presented. The percentage of participants was calculated by dividing the number of participants with a ≥20% improvement in PANSS total score (yes) by the total number of participants.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 43
    End point values
    		 GWP42003 1000 mg/day Placebo
    Number of subjects analysed
    42
    44
    Units: participants
        Yes
    12
    6
        No
    30
    38
    Statistical analysis title
    		 GWP42003 1000 mg/day, Placebo
    Comparison groups
    GWP42003 1000 mg/day v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0896 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 8
    Notes
    [1] - Responder (yes/no) is the dependent variable with treatment included as a factor and age and baseline PANSS, G, and N scores included as covariates.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 through Day 57
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    GWP42003 1000 mg/day
    Reporting group description
    		 Participants received GWP42003 (100 mg/mL), 5 mL BID administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (0 mL cannabidiol [CBD]), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.

    Serious adverse events
    		 GWP42003 1000 mg/day Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 45 (2.22%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 GWP42003 1000 mg/day Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 43 (18.60%)
    10 / 45 (22.22%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 43 (6.98%)
    4 / 45 (8.89%)
         occurrences all number
    3
    4
    Somnolence
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 45 (6.67%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 43 (9.30%)
    2 / 45 (4.44%)
         occurrences all number
    4
    2
    Nausea
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 45 (0.00%)
         occurrences all number
    4
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    0
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2014
    The amendment to this study included updates to study objectives and endpoints to better reflect the exploratory nature of the Phase 2a study. Study objectives were combined rather than being separated into primary and secondary objectives. The study endpoints were then designated as "key" and "non-key" endpoints, based on their importance to the treatment of schizophrenia in this participant population.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29241357
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