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    Clinical Trial Results:
    A randomised controlled feasibility trial comparing clinical and cost effectiveness of cognitive behavioural therapy (CBT) and selective serotonin reuptake inhibitors (SSRI) and their combination in the management of obsessive compulsive disorder.

    Summary
    EudraCT number
    2013-003219-22
    Trial protocol
    GB  
    Global end of trial date
    17 Jul 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Jul 2019
    First version publication date
    05 Jul 2019
    Other versions
    Summary report(s)
    Letter to MHRA re Final Report
    Final Report Summary
    Final Data Report
    Knowledge Exchange Meeting
    OTO Final Report

    Trial information

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    Trial identification
    Sponsor protocol code
    LMS/SF/UH/0018
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Hertfordshire
    Sponsor organisation address
    College lane, Hatfield, Hertfordshire, United Kingdom, AL10 9AB
    Public contact
    Solange Wyatt, University of Hertfordshire, +44 1707284642, s.wyatt5@herts.ac.uk
    Scientific contact
    Solange Wyatt, University of Hertfordshire, +44 1707284642, s.wyatt5@herts.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
    17 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main research question is to find out whether it is possible to carry out a randomised study looking at whether sertraline alone or cognitive behavioural therapy alone or a combination of both sertraline and cognitive behavioural therapy is better in treating obsessive compulsive disorder (OCD). The study will look at what obstacles there are in recruiting into a large trial, the practicality of delivering treatment and the acceptability to patients. Symptom changes, quality of life changes and resource use will also be assessed.
    Protection of trial subjects
    Patients given a 24hr contact number of Clinical staff if experiencing distress
    Background therapy
    -
    Evidence for comparator
    All treatments are standard of care
    Actual start date of recruitment
    05 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
    United Kingdom: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    49
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study recruited across 3 sites. 258 potential participants, 66 were screened and 49 entered the study. 15 randomised to Sertraline Monotherapy (Arm A), 18 randomised to the combination arm (Arm B) and 16 participants allocated Cognitive Behavioural Therapy (CBT) with Exposure and Response Prevention (ERP) Monotherapy (Arm C).

    Pre-assignment
    Screening details
    1. Community-based service-users, aged 18-65 years 2. DSM-IV OCD, determined by a research psychiatrist using the Mini International Neuropsychiatric Inventory (MINI) for DSM-IV (version 6.0) 3. Duration of symptoms >1 year (from medical history) 4. Baseline score >16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind [1]
    Roles blinded
    Data analyst, Assessor [2]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Sertraline hydrochloride (Arm A)
    Arm description
    Sertraline hydrochloride Monotherapy
    Arm type
    Experimental

    Investigational medicinal product name
    Sertraline Hydrochloride
    Investigational medicinal product code
    MIA (IMP)11149
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The treatment for patients randomised to Arm A will be Sertraline hydrochloride (50-200mg) monotherapy once a day for 52 weeks. Sertraline will be flexibly up-titrated from 50-200mg in accordance with the licence and guided by tolerability and clinician-based judgement. Doses may be adjusted upwards or downwards for the first 8 weeks, aiming for the 200mg dose if tolerated

    Arm title
    Arm B
    Arm description
    Cognitive Behavioural Therapy (CBT) with Exposure Response Prevention monotherapy for a total of 16 hours over 8 weeks
    Arm type
    Behavioural Treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Combination (Arm C)
    Arm description
    A combination of Sertraline hydrochloride and Cognitive Behavioural Therapy (CBT) with Exposure Response Prevention (ERP)
    Arm type
    Active comparator

    Investigational medicinal product name
    Sertraline Hydrochloride
    Investigational medicinal product code
    MIA (IMP)11149
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The treatment for patients randomised to Arm C will include Sertraline hydrochloride (50-200mg) monotherapy once a day for 52 weeks. Sertraline will be flexibly up-titrated from 50-200mg in accordance with the licence and guided by tolerability and clinician-based judgement. Doses may be adjusted upwards or downwards for the first 8 weeks, aiming for the 200mg dose if tolerated Additionally subjects receive CBT and ERP

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: This was a partially blinded study as one treatment was obvious to patients, statistician and assessor were the only blinded parties
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This was a partially blinded study as one treatment was obvious to patients, statistician and assessor were the only blinded parties
    Number of subjects in period 1
    Sertraline hydrochloride (Arm A) Arm B Combination (Arm C)
    Started
    15
    16
    18
    8 week Follow UP
    9
    12
    14
    52 week Follow up
    6
    8
    9
    Completed
    6
    8
    9
    Not completed
    9
    8
    9
         Consent withdrawn by subject
    6
    4
    9
         Lost to follow-up
    3
    4
    -

    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
    49 49
    Age categorical
    Treatment-seeking adult OCD patients (aged 18-65yrs) with DSM-IV OCD52 using the MINI for DSM-IV, with a duration of symptoms >1 year and a baseline score >16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
    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)
    49 49
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    28 28
        Male
    21 21
    Subject analysis sets

    Subject analysis set title
    Full Analysis
    Subject analysis set type
    Full analysis
    Subject analysis set description
    randomised patients

    Subject analysis sets values
    Full Analysis
    Number of subjects
    49
    Age categorical
    Treatment-seeking adult OCD patients (aged 18-65yrs) with DSM-IV OCD52 using the MINI for DSM-IV, with a duration of symptoms >1 year and a baseline score >16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    49
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    28
        Male
    21

    End points

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    End points reporting groups
    Reporting group title
    Sertraline hydrochloride (Arm A)
    Reporting group description
    Sertraline hydrochloride Monotherapy

    Reporting group title
    Arm B
    Reporting group description
    Cognitive Behavioural Therapy (CBT) with Exposure Response Prevention monotherapy for a total of 16 hours over 8 weeks

    Reporting group title
    Combination (Arm C)
    Reporting group description
    A combination of Sertraline hydrochloride and Cognitive Behavioural Therapy (CBT) with Exposure Response Prevention (ERP)

    Subject analysis set title
    Full Analysis
    Subject analysis set type
    Full analysis
    Subject analysis set description
    randomised patients

    Primary: Variation of the primary outcome

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    End point title
    Variation of the primary outcome [1]
    End point description
    To estimate the variation of the primary outcome measure, the Y-BOCS, both within and between the three treatment arms
    End point type
    Primary
    End point timeframe
    8, 16, 32, 52 week intervals
    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: No Statistical Analysis
    End point values
    Sertraline hydrochloride (Arm A) Arm B Combination (Arm C)
    Number of subjects analysed
    7
    9
    13
    Units: Y-BOCS
        number (not applicable)
    15
    18
    16
    Attachments
    Untitled (Filename: Evaluation of YBOCS table.docx)
    No statistical analyses for this end point

    Secondary: Montgomery Asberg Depression Rating Scale

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    End point title
    Montgomery Asberg Depression Rating Scale
    End point description
    End point type
    Secondary
    End point timeframe
    Primary week 16 (please see attached table for other timepoints
    End point values
    Sertraline hydrochloride (Arm A) Arm B Combination (Arm C)
    Number of subjects analysed
    7
    9
    13
    Units: MADRS
        arithmetic mean (standard deviation)
    8.1 ( 6.5 )
    14.9 ( 10.6 )
    12.6 ( 9.3 )
    Attachments
    Untitled (Filename: Total MADRS scores table.docx)
    No statistical analyses for this end point

    Secondary: Sheehan Disability Score

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    End point title
    Sheehan Disability Score
    End point description
    End point type
    Secondary
    End point timeframe
    Primary week 16 (for other time points see attached tables)
    End point values
    Sertraline hydrochloride (Arm A) Arm B Combination (Arm C)
    Number of subjects analysed
    7
    9
    13
    Units: SD scores
        arithmetic mean (standard deviation)
    13.5 ( 9.9 )
    13.8 ( 8.3 )
    9.3 ( 8.9 )
    Attachments
    Untitled (Filename: Evaluation of CGI and SDS table.docx)
    No statistical analyses for this end point

    Secondary: CGI Severity

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    End point title
    CGI Severity
    End point description
    End point type
    Secondary
    End point timeframe
    Primary week 16 (for other time points see attached table)
    End point values
    Sertraline hydrochloride (Arm A) Arm B Combination (Arm C)
    Number of subjects analysed
    7
    9
    13
    Units: CGI
        arithmetic mean (standard deviation)
    3.7 ( 1.2 )
    4.3 ( 1.2 )
    4.1 ( 1.2 )
    Attachments
    Untitled (Filename: Evaluation of CGI and SDS table.docx)
    No statistical analyses for this end point

    Secondary: CGI Improvement

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    End point title
    CGI Improvement
    End point description
    End point type
    Secondary
    End point timeframe
    Primary week 16 (for other time points see attached table)
    End point values
    Sertraline hydrochloride (Arm A) Arm B Combination (Arm C)
    Number of subjects analysed
    7
    9
    13
    Units: CGI
        arithmetic mean (standard deviation)
    3.2 ( 0.8 )
    3.6 ( 1.4 )
    3.4 ( 1.1 )
    Attachments
    Untitled (Filename: Evaluation of CGI and SDS table.docx)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 weeks following randomisation
    Adverse event reporting additional description
    The research psychiatrist assessed patients who are randomised to receive sertraline at weeks 2, 4, 8, 16, 24, 32 and 52. The research nurse assessed all patients randomised to the CBT with ERP monotherapy arm at weeks 2, 4, 8, 16, 32 and 52 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Sertraline hydrochloride (Arm A)
    Reporting group description
    Sertraline hydrochloride Monotherapy

    Reporting group title
    Arm B
    Reporting group description
    Cognitive Behavioural Therapy (CBT) with Exposure Response Prevention monotherapy for a total of 16 hours over 8 weeks

    Reporting group title
    Combination (Arm C)
    Reporting group description
    A combination of Sertraline hydrochloride and Cognitive Behavioural Therapy (CBT) with Exposure Response Prevention (ERP)

    Serious adverse events
    Sertraline hydrochloride (Arm A) Arm B Combination (Arm C)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Surgical and medical procedures
    Aborted pregnancy
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Sertraline hydrochloride (Arm A) Arm B Combination (Arm C)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 15 (66.67%)
    11 / 18 (61.11%)
    16 / 16 (100.00%)
    Investigations
    Weight gain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    4 / 16 (25.00%)
         occurrences all number
    0
    1
    6
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Road traffic accident
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 15 (26.67%)
    0 / 18 (0.00%)
    7 / 16 (43.75%)
         occurrences all number
    6
    0
    7
    Headache
         subjects affected / exposed
    4 / 15 (26.67%)
    2 / 18 (11.11%)
    8 / 16 (50.00%)
         occurrences all number
    5
    2
    15
    Numbness in face
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Slow speech
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Tremor
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    0
    Vertigo
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Decreased appetite
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    3
    Feeling jittery
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Irritability
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Orofacial oedema
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Sweating
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 18 (11.11%)
    9 / 16 (56.25%)
         occurrences all number
    7
    2
    20
    Tiredness
         subjects affected / exposed
    5 / 15 (33.33%)
    4 / 18 (22.22%)
    7 / 16 (43.75%)
         occurrences all number
    11
    6
    11
    Ill-defined disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Social circumstances
    Refusal of treatment by patient
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Sexual assault
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    3 / 16 (18.75%)
         occurrences all number
    1
    1
    3
    Constipation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Diarrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    2 / 16 (12.50%)
         occurrences all number
    1
    1
    4
    Dry mouth
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    7 / 16 (43.75%)
         occurrences all number
    1
    1
    15
    Dyspepsia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    1
    0
    5
    Nausea
         subjects affected / exposed
    4 / 15 (26.67%)
    4 / 18 (22.22%)
    4 / 16 (25.00%)
         occurrences all number
    6
    5
    14
    Teeth grinding
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    6
    Respiratory, thoracic and mediastinal disorders
    Yawning
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Hair loss
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    Itching
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Affect lability
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Aggression
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Agitation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Anxiety
         subjects affected / exposed
    4 / 15 (26.67%)
    5 / 18 (27.78%)
    8 / 16 (50.00%)
         occurrences all number
    8
    10
    22
    Crying Abnormal
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Daydreaming
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Delayed orgasm
         subjects affected / exposed
    6 / 15 (40.00%)
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    3
    0
    4
    Depressed mood
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 18 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    1
    Depression
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Difficulty thinking
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Dissociation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Emotional disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Insomnia
         subjects affected / exposed
    7 / 15 (46.67%)
    3 / 18 (16.67%)
    8 / 16 (50.00%)
         occurrences all number
    11
    3
    16
    Apathy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    0
    Mental exhaustion
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Migraine
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Nervousness
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 18 (11.11%)
    6 / 16 (37.50%)
         occurrences all number
    2
    6
    14
    Panic attacks
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 18 (16.67%)
    11 / 16 (68.75%)
         occurrences all number
    0
    3
    1
    Restlessness
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 18 (5.56%)
    4 / 16 (25.00%)
         occurrences all number
    3
    1
    7
    Sexual desire decreased
         subjects affected / exposed
    5 / 15 (33.33%)
    1 / 18 (5.56%)
    3 / 16 (18.75%)
         occurrences all number
    5
    1
    6
    Suicidal ideation
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    3
    Time perception altered
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Vivid dreams
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    1
    Musculoskeletal and connective tissue disorders
    Dislocated shoulder
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Fibula fracture
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Hand pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Jaw stiffness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Muscle tension
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    2 / 16 (12.50%)
         occurrences all number
    3
    1
    3
    Muscle twitching
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 18 (5.56%)
    3 / 16 (18.75%)
         occurrences all number
    3
    1
    5
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2015
    Change of address of CI. Pregnancy form introduced. RPs allowed to perform all screening. Patients permitted to collect study medication.
    26 May 2015
    Addition of further recruitment strategies. Allowing support of patients between visits. Decrease of wash out time. Clarifying follow up. Reference to use of social media removed
    25 Aug 2015
    Adverts for OCD Action website produced.
    14 Oct 2015
    Press release, advert for Trust TV screens and piece for R+D newsletter produced. Trained team members to administer CANTAB if necessary.
    09 Jan 2017
    Changes made to interview process to address feedback from REC.

    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/3011392
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    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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