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    Clinical Trial Results:
    Assessing the subjective intensity of oral psilocybin in patients with treatment-resistant depression: A Pilot Study

    Summary
    EudraCT number
    		 2013-003196-35
    Trial protocol
    		 GB  
    Global end of trial date
    27 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2020
    First version publication date
    03 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    13HH0762
    Additional study identifiers
    ISRCTN number
    		 ISRCTN14426797
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 REC: 13/LO/1224 , MRC: MR/J00460X/1
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    Exhibition Road, London, United Kingdom, SW7 2AZ
    Public contact
    Carhart-Harris, Robin, Imperial College London, 44 02075946550, r.carhart-harris@imperial.ac.uk
    Scientific contact
    Carhart-Harris, Robin, Imperial College London, 44 02075946550, r.carhart-harris@imperial.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
    13 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    How sensitive are patients with depression to the subjective effects of psilocybin?
    Protection of trial subjects
    24-hour contact number to study psychiatrist
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jan 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Most recruitment happened through self-referrals and also through the Clinical Research Network. Patients first had a telephone screening and if they appeared suitable came in for a face-to-face screening. 120 subjects applied, 74 were telephone screened, 29 did a face-to-face screening. 20 were enrolled, 19 completed.

    Pre-assignment
    Screening details
    		 Inclusion: Major depression moderate-severe (HAMD 17+) and no response to at least 2 full courses of treatment within current episode. Exclusion: history of psychosis and family members with psychosis, medically significant conditions, history of suicide attempts, needle and blood phobia, pregnancy at screening or during study, current addiction.

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

    Period 1
    Period 1 title
    Baseline fMRI and Prep
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA - open label safety pilot study

    Arms
    Arm title
    		 All patients - baseline
    Arm description
    		 All patients were prepped for psilocybin sessions, did baseline questionnaires and fMRI.
    Arm type
    		 No intervention, run-in period

    Investigational medicinal product name
    No intervention
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Other use
    Dosage and administration details
    No intervention, run-in, preparation period

    Number of subjects in period 1
    		All patients - baseline
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 All patients - treatment
    Arm description
    		 Patients receive two doses of psilocybin, 1 week apart
    Arm type
    		 Experimental

    Investigational medicinal product name
    Psilocybin 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2x 5mg capsules = 10mg psilocybin

    Investigational medicinal product name
    Psilocybin 25mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5x 5mg capsules = 25mg

    Number of subjects in period 2
    		All patients - treatment
    Started
    20
    10mg psilocybin session
    20
    25mg psilocybin session
    20
    Completed
    20
    Period 3
    Period 3 title
    Post-treatment follow-ups
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 All patients
    Arm description
    		 fmRI and remote follow-ups up to 6 months
    Arm type
    		 all, no arms

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		All patients
    Started
    20
    Completed
    19
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline fMRI and Prep
    Reporting group description
    		 -

    Reporting group values
    		 Baseline fMRI and Prep Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    All patients - baseline
    Reporting group description
    		 All patients were prepped for psilocybin sessions, did baseline questionnaires and fMRI.
    Reporting group title
    All patients - treatment
    Reporting group description
    		 Patients receive two doses of psilocybin, 1 week apart
    Reporting group title
    All patients
    Reporting group description
    		 fmRI and remote follow-ups up to 6 months

    Primary: Quick Inventory of Depressive Symptomatology (QIDS-16)

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    End point title
    		 Quick Inventory of Depressive Symptomatology (QIDS-16)
    End point description
    End point type
    Primary
    End point timeframe
    Baseline vs 5 weeks post treatment
    End point values
    		 All patients - baseline All patients
    Number of subjects analysed
    19
    19
    Units: QIDS score
    19
    10
    Statistical analysis title
    		 two-tailed paired t-test (Bonferroni corrected)
    Comparison groups
    All patients - baseline v All patients
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Beck Depression Inventory (BDI)

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    End point title
    		 Beck Depression Inventory (BDI)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline vs 1 week post-treatment
    End point values
    		 All patients - baseline All patients
    Number of subjects analysed
    19
    19
    Units: BDI score
    35
    12
    Statistical analysis title
    		 two-tailed paired t-test (Bonferroni corrected)
    Comparison groups
    All patients - baseline v All patients
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: State Trait Anxiety Inventory - Trait (STAI-T)

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    End point title
    		 State Trait Anxiety Inventory - Trait (STAI-T)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline vs 1 week post treatment
    End point values
    		 All patients - baseline All patients
    Number of subjects analysed
    19
    19
    Units: STAI-T units
    69
    45
    Statistical analysis title
    		 two-tailed paired t-test (Bonferroni corrected)
    Comparison groups
    All patients v All patients - baseline
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    just before, during and few days after psilocybin sessions
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    NK
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (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
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 20 (100.00%)
    General disorders and administration site conditions
    Headache
    Additional description: Lasting 1-2 days
         subjects affected / exposed
    8 / 20 (40.00%)
         occurrences all number
    8
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 20 (25.00%)
         occurrences all number
    5
    Psychiatric disorders
    Anxiety
    Additional description: Transient anxiety lasting minutes
         subjects affected / exposed
    15 / 20 (75.00%)
         occurrences all number
    15
    Paranoia
    Additional description: Transient paranoia
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3

    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.
    Open label safety study, no control group.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29119217
    http://www.ncbi.nlm.nih.gov/pubmed/27210031
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    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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