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    Clinical Trial Results:
    A multicentre study to assess safety and efficacy of psilocybin in patients with treatment-resistant depression following completion of COMP 001 and COMP 003 trials (P-TRD LTFU)

    Summary
    EudraCT number
    		 2020-001348-25
    Trial protocol
    		 PT   CZ   DK   NL   DE  
    Global end of trial date
    11 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Mar 2024
    First version publication date
    20 Mar 2024
    Other versions
    Summary report(s)
    		 COMP 004 Efficacy Endpoints

    Trial information

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    Trial identification
    Sponsor protocol code
    COMP 004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    COMPASS Pathfinder Limited
    Sponsor organisation address
    3rd Floor, 1 Ashley Road, Altrincham, Cheshire, United Kingdom, WA14 2DT
    Public contact
    Guy Goodwin, COMPASS Pathways, Ltd, COMPASS Pathways, Ltd., 44 7443 136539, info@compasspathways.com
    Scientific contact
    Guy Goodwin, COMPASS Pathways, Ltd, COMPASS Pathways, Ltd., 44 7443 136539, info@compasspathways.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
    07 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin groups from COMP 001).
    Protection of trial subjects
    All participants will be evaluated for safety and efficacy at enrollment, weeks 6, 9 & 12 (for participants from COMP 003 only) and at weeks 16, 20, 24, 28, 40 and 52. Participants’ companions (friend or family member) will continue to be educated about the signs of worsening of depression and suicidality, and instructed on ways to contact the study team in case of significant worsening of depression. Rescue medications are allowed during the study as described in the protocol. Efficacy and safety assessments including Adverse Events are performed throughout the study up to the end of study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 May 2020
    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
    Canada: 6
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    Netherlands: 50
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    United Kingdom: 33
    Country: Number of subjects enrolled
    Czechia: 7
    Country: Number of subjects enrolled
    Denmark: 8
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Ireland: 20
    Country: Number of subjects enrolled
    United States: 106
    Worldwide total number of subjects
    252
    EEA total number of subjects
    107
    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)
    245
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects recruited into this study must have completed either the COMP 001 or COMP 003 study prior to entry into this long-term, observational follow up study.

    Pre-assignment
    Screening details
    		 At the Screening visit (V1), the following assessments will be performed and recorded: ICF, review of inclusion/exclusion criteria, loading the app on the participant’s mobile phone if the participant opts to participate, set up subjects on the digital system for online assessments and for participants from COMP 001 they will be asked the TiC-P.

    Period 1
    Period 1 title
    Originator Study Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 COMP360 25 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    COMP360
    Investigational medicinal product code
    Other name
    Psilocybin
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    COMP360 25mg single dose treatment: 5 x 5 mg capsules

    Arm title
    		 COMP360 10 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    COMP360
    Investigational medicinal product code
    Other name
    Psilocybin
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    COMP360 10mg single dose treatment: 2 × 5 mg capsules and 3 × placebo capsules

    Arm title
    		 COMP360 1 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    COMP360
    Investigational medicinal product code
    Other name
    Psilocybin
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    COMP360 1 mg single dose treatment: 1 × 1 mg capsule and 4 × placebo capsules

    Arm title
    		 COMP360 25 mg + SSRI
    Arm description
    		 -
    Arm type
    		 adjunctive therapy

    Investigational medicinal product name
    SSRI
    Investigational medicinal product code
    Other name
    SSRI
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Adjunctive therapy taken in the lead in study COMP 003.

    Number of subjects in period 1
    		COMP360 25 mg COMP360 10 mg COMP360 1 mg COMP360 25 mg + SSRI
    Started
    79
    75
    79
    19
    Completed
    74
    66
    69
    19
    Not completed
    5
    9
    10
    0
         Consent withdrawn by subject
    2
    6
    6
    -
         Physician decision
    -
    -
    1
    -
         Adverse event, non-fatal
    2
    2
    -
    -
         Lost to follow-up
    1
    -
    2
    -
         Lack of efficacy
    -
    1
    1
    -
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 COMP360 25 mg
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 COMP360 10 mg
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 COMP360 1 mg
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 COMP360 25 mg + SSRI
    Arm description
    		 -
    Arm type
    		 adjunctive therapy

    Investigational medicinal product name
    SSRI
    Investigational medicinal product code
    Other name
    SSRI
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Adjunctive therapy taken in the lead in study COMP 003.

    Number of subjects in period 2 [1]
    		COMP360 25 mg COMP360 10 mg COMP360 1 mg COMP360 25 mg + SSRI
    Started
    22
    19
    17
    8
    Completed
    16
    14
    15
    3
    Not completed
    6
    5
    2
    5
         Consent withdrawn by subject
    -
    4
    2
    1
         Non-compliance
    3
    -
    -
    2
         Participant no longer wants to continue in study
    -
    -
    -
    1
         Lost to follow-up
    3
    1
    -
    1
    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: Not all participants continued from the COMP 001 and COMP 003 lead-in studies into the COMP 004 follow-up study as not all participants had the opportunity to enroll due to delayed study set-up. For those that did have the opportunity to enroll, participation was optional.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    COMP360 25 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 10 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 1 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 25 mg + SSRI
    Reporting group description
    		 -

    Reporting group values
    		 COMP360 25 mg COMP360 10 mg COMP360 1 mg COMP360 25 mg + SSRI Total
    Number of subjects
    		 79 75 79 19 252
    Age categorical
    Units: Subjects
        18 to 34 Years
    		 24 29 31 4 88
        35 to 64 Years
    		 52 44 46 15 157
        65 to 84 Years
    		 3 2 2 0 7
        >84 Years
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.2 ( 12.19 ) 40.6 ( 12.76 ) 38.7 ( 11.71 ) 42.2 ( 10.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 44 41 36 13 134
        Male
    		 35 34 43 6 118
    Race
    Units: Subjects
        White
    		 70 72 73 15 230
        Black or African American
    		 4 0 1 2 7
        Asian
    		 4 3 5 0 12
        American Indian or Alaska Native
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Other
    		 1 0 0 2 3
    Prior Psilocybin Experience
    Units: Subjects
        Yes
    		 5 5 4 0 14
        No
    		 74 70 75 0 219
        Not Recorded
    		 0 0 0 19 19
    Number of Failed Treatments for the Current Episode
    Units: Subjects
        One (1)
    		 0 1 1 0 2
        Two (2)
    		 66 62 63 12 203
        Three (3)
    		 8 9 11 6 34
        Four (4)
    		 4 2 3 1 10
        Unknown
    		 1 1 1 0 3
    HAM-D-17 Baseline Severity Categories
    Units: Subjects
        Moderate (18-23)
    		 57 49 59 17 182
        Severe (≥ 24)
    		 22 26 20 2 70
    MGH-ATRQ
    Units: Subjects
        <25% Improved
    		 55 47 46 13 161
        25 - 49% Improved
    		 24 26 32 6 88
        50 - 75% Improved
    		 0 2 1 0 3
        >75% Improved
    		 0 0 0 0 0
    Length of Current Depressive Episode
    Units: Subjects
        < 1 year
    		 12 10 10 3 35
        ≥ 1 year and < 2 years
    		 33 28 33 13 107
        ≥ 2 years
    		 34 37 36 3 110
    Weight at Screening
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 79.877 ( 19.4131 ) 83.363 ( 25.7905 ) 83.102 ( 23.3533 ) 75.420 ( 19.3330 ) -
    Height at Screening
    Units: centimeters
        arithmetic mean (standard deviation)
    		 173.401 ( 10.3295 ) 173.186 ( 11.3620 ) 173.773 ( 9.8703 ) 169.4 ( 9.94 ) -
    Body Mass Index
    Units: kilograms/meters^2
        arithmetic mean (standard deviation)
    		 26.52 ( 6.134 ) 28.26 ( 8.203 ) 27.26 ( 6.025 ) 26.26 ( 6.521 ) -
    HAM-D-17 Total Score
    Units: Points
        arithmetic mean (standard deviation)
    		 21.8 ( 3.04 ) 22.4 ( 2.77 ) 22.2 ( 2.93 ) 20.3 ( 2.75 ) -
    MSI-BPD Total Score
    Units: Points
        arithmetic mean (standard deviation)
    		 2.1 ( 1.64 ) 2.1 ( 1.55 ) 1.8 ( 1.62 ) 1.6 ( 1.50 ) -
    Length of Current Depressive Episode
    Units: Months
        arithmetic mean (standard deviation)
    		 42.41 ( 48.930 ) 42.09 ( 39.934 ) 38.34 ( 43.727 ) 23.5 ( 22.06 ) -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consists of all enrolled participants in COMP 004 that complete at least one efficacy assessment.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Analysis Set consists of all enrolled participants in COMP 004.

    Subject analysis set title
    Modified Full Analysis Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The modified Full Analysis Set (mFAS) consists of all enrolled participants in COMP 001/ COMP 003 that complete at least one efficacy assessment, which was 252. This analysis set also includes patients that were not enrolled in the COMP 004 study. 66 of these patients were enrolled into this study.

    Subject analysis sets values
    		 Full Analysis Set Safety Analysis Set Modified Full Analysis Set
    Number of subjects
    66
    66
    252
    Age categorical
    Units: Subjects
        18 to 34 Years
    23
    23
    88
        35 to 64 Years
    40
    40
    157
        65 to 84 Years
    3
    3
    7
        >84 Years
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.1 ( 12.04 )
    41.1 ( 12.04 )
    ( )
    Gender categorical
    Units: Subjects
        Female
    32
    32
    134
        Male
    34
    34
    118
    Race
    Units: Subjects
        White
    62
    62
    230
        Black or African American
    2
    2
    7
        Asian
    0
    0
    12
        American Indian or Alaska Native
    0
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
    0
        Other
    2
    2
    3
    Prior Psilocybin Experience
    Units: Subjects
        Yes
    3
    3
    14
        No
    55
    55
    219
        Not Recorded
    8
    8
    19
    Number of Failed Treatments for the Current Episode
    Units: Subjects
        One (1)
    0
    0
    2
        Two (2)
    53
    53
    203
        Three (3)
    10
    10
    34
        Four (4)
    3
    3
    10
        Unknown
    0
    0
    3
    HAM-D-17 Baseline Severity Categories
    Units: Subjects
        Moderate (18-23)
    50
    50
    182
        Severe (≥ 24)
    16
    16
    70
    MGH-ATRQ
    Units: Subjects
        <25% Improved
    42
    42
    161
        25 - 49% Improved
    22
    22
    88
        50 - 75% Improved
    2
    2
    3
        >75% Improved
    0
    0
    0
    Length of Current Depressive Episode
    Units: Subjects
        < 1 year
    11
    11
    35
        ≥ 1 year and < 2 years
    21
    21
    107
        ≥ 2 years
    34
    34
    110
    Weight at Screening
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    84.948 ( 21.6662 )
    84.948 ( 21.6662 )
    ( )
    Height at Screening
    Units: centimeters
        arithmetic mean (standard deviation)
    173.739 ( 11.9752 )
    173.739 ( 11.9752 )
    ( )
    Body Mass Index
    Units: kilograms/meters^2
        arithmetic mean (standard deviation)
    28.35 ( 7.389 )
    28.35 ( 7.389 )
    ( )
    HAM-D-17 Total Score
    Units: Points
        arithmetic mean (standard deviation)
    21.5 ( 2.78 )
    21.5 ( 2.78 )
    ( )
    MSI-BPD Total Score
    Units: Points
        arithmetic mean (standard deviation)
    1.9 ( 1.49 )
    1.9 ( 1.49 )
    ( )
    Length of Current Depressive Episode
    Units: Months
        arithmetic mean (standard deviation)
    40.34 ( 40.760 )
    40.34 ( 40.760 )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    COMP360 25 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 10 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 1 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 25 mg + SSRI
    Reporting group description
    		 -
    Reporting group title
    COMP360 25 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 10 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 1 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 25 mg + SSRI
    Reporting group description
    		 -

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consists of all enrolled participants in COMP 004 that complete at least one efficacy assessment.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Analysis Set consists of all enrolled participants in COMP 004.

    Subject analysis set title
    Modified Full Analysis Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The modified Full Analysis Set (mFAS) consists of all enrolled participants in COMP 001/ COMP 003 that complete at least one efficacy assessment, which was 252. This analysis set also includes patients that were not enrolled in the COMP 004 study. 66 of these patients were enrolled into this study.

    Primary: Time to Depressive Event

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    End point title
    		 Time to Depressive Event [1] [2]
    End point description
    Time to the first depressive event (from COMP360 dose in the prior study) in participants recruited from the COMP 001 study. A participant withdrawing from the study for reported lack of efficacy that did not experience any of the relevant depressive events will be considered as having the event at the time of discontinuation
    End point type
    Primary
    End point timeframe
    Whole Study
    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: Data are summarised for this endpoint as detailed in SAP amendment
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For the primary endpoint the COMP360 25mg + SSRI arm was not of interest and thus was not analysed.
    End point values
    		 COMP360 25 mg COMP360 10 mg COMP360 1 mg
    Number of subjects analysed
    79
    75
    79
    Units: Days
        median (confidence interval 95%)
    92 (42 to 199)
    83 (39 to 142)
    62 (28 to 9999.99)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Full study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    COMP360 25 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 10 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 1 mg
    Reporting group description
    		 -

    Reporting group title
    COMP360 25 mg + SSRI
    Reporting group description
    		 -

    Serious adverse events
    		 COMP360 25 mg COMP360 10 mg COMP360 1 mg COMP360 25 mg + SSRI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    2 / 17 (11.76%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Therapy change
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 COMP360 25 mg COMP360 10 mg COMP360 1 mg COMP360 25 mg + SSRI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 22 (77.27%)
    15 / 19 (78.95%)
    15 / 17 (88.24%)
    6 / 8 (75.00%)
    Vascular disorders
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Surgical and medical procedures
    Wisdom teeth removal
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 19 (10.53%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Feeling abnormal
         subjects affected / exposed
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Chills
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hangover
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Crying
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Feeling jittery
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Feeling of relaxation
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Uterine spasm
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hypopnoea
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    3 / 17 (17.65%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    4
    0
    Insomnia
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 19 (10.53%)
    3 / 17 (17.65%)
    0 / 8 (0.00%)
         occurrences all number
    2
    2
    3
    0
    Suicidal ideation
         subjects affected / exposed
    2 / 22 (9.09%)
    2 / 19 (10.53%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    2
    2
    2
    0
    Depression
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    1
    Euphoric mood
         subjects affected / exposed
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Time perception altered
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Affect lability
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Depressive symptom
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hallucination, visual
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Mood altered
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Panic attack
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Abnormal dreams
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Depersonalisation/derealisation disorder
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Emotional disorder
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Feeling of despair
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hallucination, auditory
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hallucinations, mixed
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Illusion
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Inappropriate affect
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Irritability
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Libido decreased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thinking abnormal
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Liver function test increased
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Mitral valve incompetence
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 22 (36.36%)
    5 / 19 (26.32%)
    5 / 17 (29.41%)
    2 / 8 (25.00%)
         occurrences all number
    9
    6
    7
    2
    Dizziness
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    0
    1
    Dreamy state
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Sensory disturbance
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Aphasia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Disturbance in attention
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypersomnia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Mental impairment
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 22 (18.18%)
    0 / 19 (0.00%)
    2 / 17 (11.76%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    2
    0
    Diarrhoea
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 17 (11.76%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    2
    1
    Abdominal discomfort
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    1
    Dyspepsia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pancreatic cyst
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 17 (11.76%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Arthralgia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Limb discomfort
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle tightness
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 22 (18.18%)
    2 / 19 (10.53%)
    3 / 17 (17.65%)
    0 / 8 (0.00%)
         occurrences all number
    4
    2
    3
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Increased appetite
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 8 (0.00%)
         occurrences all number
    0
    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
    20 Nov 2020
    Amendment 1 (V2) dated 20 Nov 2020 changes: -The mobile phone application used for passive data collection was changed from the Mindstrong application to the Measure Health application as the Mindstrong application had become unavailable. Section 7.3 of the protocol was updated to replace the wording for the Mindstrong application with wording for the Measure Health application. -Other minor edits to the protocol to clarify methodology.

    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
    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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