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    Summary
    EudraCT Number:2014-004077-16
    Sponsor's Protocol Code Number:14/0249
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-07-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-004077-16
    A.3Full title of the trial
    A Phase IV randomised controlled trial of the selective serotonin reuptake inhibitor Sertraline versus Cognitive Behavioural Therapy for anxiety symptoms in people with Generalised Anxiety Disorder (GAD) who have failed to respond to low intensity psychological interventions as defined by the NICE GAD guidelines
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical (randomised controlled) trial comparing treatments for generalised anxiety disorder (GAD) with patients who have failed to respond to low intensity psychological interventions as defined by the NICE GAD guidelines: the drug Sertraline versus Cognitive Behavioural Therapy.
    A.3.2Name or abbreviated title of the trial where available
    ToSCA: Trial of Sertraline versus CBT for generalised Anxiety
    A.4.1Sponsor's protocol code number14/0249
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity College London Joint Research Office
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCL
    B.5.2Functional name of contact pointDr Marta Buszewicz
    B.5.3 Address:
    B.5.3.1Street AddressResearch Department of Primary Care and Population Health, Rowland Hill Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW3 2PF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02077940500
    B.5.6E-mailm.buszewicz@ucl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSertraline
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSertraline Hydrochloride
    D.3.9.1CAS number 79559-97-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Generalised anxiety disorder (GAD)
    E.1.1.1Medical condition in easily understood language
    Generalised anxiety disorder (GAD)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10018075
    E.1.2Term Generalised anxiety disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the clinical effectiveness at 12 months of treatment with the SSRI Sertraline compared to Cognitive Behavioural Therapy (CBT) for patients with persistent GAD (Generalised Anxiety Disorder) which has not improved with low intensity psychological interventions.
    E.2.2Secondary objectives of the trial
    To calculate the cost-effectiveness at 12 months of treatment with the SSRI Sertraline compared to CBT for patients with persistent GAD (Generalised Anxiety Disorder) which has not improved with low intensity psychological interventions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Aged 18 or above
    Gender: male or female
    Positive score of 10+ on GAD-7
    Primary diagnosis of GAD as diagnosed on the Mini-International Neuropsychiatric Interview (M.I.N.I.)
    Failure to respond to NICE defined step 1 and 2 low intensity interventions for GAD
    E.4Principal exclusion criteria
    Inability to complete questionnaires due to insufficient English or cognitive impairment
    Current major depression
    Other comorbid anxiety disorder(s) of more severity or distress to the participant than their GAD
    Significant dependence on alcohol or illicit drugs
    Comorbid psychotic disorder, bipolar disorder
    Treatment with antidepressants in past 8 weeks or any high intensity psychological therapy within past 6 months
    Currently on contraindicated medication: monoamine oxidase Inhibitors within the past 14 days or pimozide.
    Patients with poorly controlled epilepsy
    Concurrent enrolment in another IMP (medication) trial
    Women who are currently pregnant or planning pregnancy or lactating
    Severe hepatic impairment
    Patient on anti-coagulants
    History of a bleeding disorder
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is GAD-7, a 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for GAD. This will be collected at baseline and at 3 monthly intervals during the 12 months treatment period from both intervention groups.

    The GAD-7 is used a as a routine patient reported outcome measure by IAPT services, which should allow comparison with the routine outcome data in NHS services.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months from baseline
    E.5.2Secondary end point(s)
    Hamilton Anxiety Rating Scale (HAM-A)

    Patient Health Questionnaire (PHQ-9)

    Work and Social Activity Scale (WASAS)

    Euroquol (EQ-5D)

    ESC - appreviated form of the CSRI

    Patient acceptability measure – CSQ.

    Patient preference rating scale

    Health Service Outcomes - We will collect health service use data from both intervention arms at the 12 month treatment completion point as follows: GP consultations coded for GAD and psychotropic drug prescriptions.
    We will also collect data on the number of attendances at CBT sessions from
    the IAPT services delivering the CBT intervention to participants in that arm
    E.5.2.1Timepoint(s) of evaluation of this end point
    Hamilton Anxiety Rating Scale (HAM-A) - administered by a member of the research team at baseline and 12 month follow-up.
    Patient Health Questionnaire (PHQ-9) - collected 3 monthly for the 12 months duration of the study, along with the GAD-7 and EQ-5D.
    Work and Social Activity Scale (WASAS) - collected at baseline and 12 months follow-up.
    Euroquol (EQ-5D) – collected 3 monthly for the 12 months duration of the study, along with the GAD-7 and PHQ-9.
    ESC / abbreviated CSRI - collected at baseline, 6 and 12 month follow-up.
    Patient acceptability measure – CSQ - colected at 3 and 12 months
    Patient preference rating scale – administered at baseline and 12 month follow-up.
    Health Service Outcomes - collected over 12 month duration
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cognitive Behavioural Therapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned16
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Collection of last data regarding health service resource use of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state360
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Once the research has finished participants will revert to receiving usual care from their GP.

    If they have been receiving Sertraline and consider that they have benefited from this then their GP should agree to continuing to prescribe this medication. However, If they do not think it is controlling their symptoms adequately or they would like to try a different treatment which may mean they don't need to take medication long-term they can ask to be referred to be considered for a course CBT
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CRN: North Thames Central Office
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-02-08
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