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    Summary
    EudraCT Number:2013-003219-22
    Sponsor's Protocol Code Number:LMS/SF/UH/0018
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-02
    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 number2013-003219-22
    A.3Full title of the trial
    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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimal Treatment for Obsessive Compulsive Disorder Trial
    A.3.2Name or abbreviated title of the trial where available
    Optimal Treatment for OCD (OTO) Version 1.0
    A.4.1Sponsor's protocol code numberLMS/SF/UH/0018
    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 SponsorHertfordshire Partnership University NHS Foundation Trust
    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 of Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Hertfordshire
    B.5.2Functional name of contact pointSolange Wyatt
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Herts, College Lane
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAl10 9AB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01707284642
    B.5.5Fax number01707285104
    B.5.6E-mails.wyatt5@herts.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Hertfordshire
    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 supportHertfordshire Partnership University Foundation NHS Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportSouth West London and St Georges Mental Health NHS Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportSouthern Health NHS Foundation Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Hertfordshire
    B.5.2Functional name of contact pointSolange Wyatt
    B.5.3 Address:
    B.5.3.1Street AddressHealth Research Building, College Lane Campus
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9AB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01707284642
    B.5.5Fax number01707285104
    B.5.6E-mails.wyatt5@herts.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 Yes
    D.2.1.1.1Trade name Sertraline
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code Generic sertraline
    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
    D.3.9.1CAS number 79559-97-0
    D.3.9.2Current sponsor codeLMS/SF/UH/00018
    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 number50 to 200
    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
    Obsessive Compulsive Disorder
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10037174
    E.1.2Term Psychiatric disorder NOS
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    Outcome measures will be evaluated. The variation in the Y-BOCS (a specific questionnaire looking at obsessions and compulsions to assess OCD severity) both within and between the three treatment arms will be evaluated. The following outcomes will also be evaluated to assess the influence on patient selection and on the change in Y-BOCS score. This will help inform the need for adjusted and stratified analysis within the large trial. The endpoints will be evaluated to enable appropriate estimation of sample size required for a full-scale trial.
    -Clinical Global Impression (CGI) Symptom Scale and CGI Improvement Scale (a scale to assess the clinical state of the patient)
    -Sheehan Disability Scale (a scale to look at how symptoms affect your life)
    -The Autistic Quotient (a questionnaire looking at autistic traits)
    -The Montgomery Asberg Depression Rating Scale
    -CANTAB: Stop signal reaction time; ID-ED; Affective go-no-go; Cambridge gamble task (computerised tasks to look at cogn
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Community based service-users, aged 18-65 years.
    2) DSM-IV OCD, determined by a psychiatrist using the MINI for DSM-IV
    3) Duration of symptoms >1 year (from medical history)
    4) Baseline score >16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
    E.4Principal exclusion criteria
    1) History of psychotic disorder (schizophrenia, psychotic symptoms, bipolar disorder), Tourette syndrome(tic disorders not amounting to Tourette syndrome will not be exclusionary), organic mental disorder, psychosurgery, personality disorder of borderline or histrionic type.
    2) Alcohol/substance-abuse disorders within the past 12 months.
    3) Any other DSM-IV Axis I disorder that is considered the primary focus of treatment
    4) Severe depression, defined by a Montgomery-Asberg Depression Rating Scale (MADRS) >30 at baseline.
    5) Actively planning suicide (scoring >4 on item 10 of MADRS)or judged by the clinician to be at significant risk of self-harm.
    6) Attended CBT involving ERP from an accredited (British Association of Behavioural and Cognitive Psychotherapies (BABCP) approved or equivalent) therapist (eg. IAPTs stage 2) in the last 6 months.
    7) Failed (inadequate clinical response, equivalent to <25% improvement) >=2 previous adequate (>12weeks) trials of CBT involving ERP from an accredited (BABCP-approved or equivalent) therapist.
    8)Failed (inadequate clinical response,equivalent to <25% improvement) >=2 previous adequate (>12weeks) trials of any SSRI or clomipramine taken at optimal doses (if maximum SPC dose, evidence of intolerance of the higher dose is needed) with adequate adherence.
    9) Needing regular psychotropic drugs other than study medication during the study (except hypnotics which will be allowed provided the dose has been stable for >12 weeks and remains so throughout the study period).
    10) Currently involved in a treatment research study.
    11)Acute or unstable physical illness including Hepatitis, HIV/AIDS, Creutzfeldt-Jakob disease
    12) Needing regular specified medication known to interact adversely with sertraline.
    13)Individual reasons making it difficult to comply with the treatment-programme, including the wash-out period.
    14)Inadequate understanding of English to participate in treatment or give informed consent.
    15) Women of child-bearing age not using reliable contraception.
    16) Pregnant or breast-feeding women.
    17) History of liver disease.
    18) Epilepsy.
    19) History of cardiovascular disease or blood disorders that increase bleeding tendency. eg. platelet disorder.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome for the study is to assess the feasibility to inform a larger clinical trial. This will be done by evaluating the number of patients willing to be randomised, evaluating the differences in methods of identifying patients, investigating premature discontinuation rates, evaluating tolerability across treatment arms and assessing resource use and quality of life. Outcome measures will also be evaluated to estimate the sample size required for a large trial. For the outcome measures the primary endpoint is to estimate the variation in the Y-BOCS both within and between the three treatment arms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The Y-BOCS will be completed at screening, baseline, week 2, week 4, week 8, week 16, week 32 and week 52.

    The trial management group will evaluate the progress (patient recruitment, discontinuation rates, tolerability) of the trial on an ongoing basis.
    E.5.2Secondary end point(s)
    The following outcome measures will be evaluated to assess the influence on patient selection and on the change in Y-BOCS score which will help inform the need for adjusted and stratified analysis within the large trial.
    -Clinical Global Impression (CGI) Symptom Scale and CGI Improvement Scale
    -Sheehan Disability Scale
    -The Autistic Quotient
    -The Montgomery Asberg Depression Rating Scale
    -CANTAB: Stop signal reaction time; ID-ED; Affective go-no-go; Cambridge gamble task
    -CSRI
    -EQ-5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    The SDS and MADRS will be evaluated at baseline, week 2, week 4, week 8, week 16, week 32 and week 52.
    The CGI symptom scale and AQ will be evaluated only a baseline.
    The EQ-5D, CSRI and CANTAB will be evaluated at baseline, week 16 and 52.
    The CGI improvement scale will be evaluated at weeks 2,4, 8, 16, 32 and 52.
    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 Yes
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Feasibility
    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 Yes
    E.8.1.7.1Other trial design description
    Rater-blinded, 3-arm trial. Sertraline vs CBT vs combination of Sertraline + CBT
    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 trial3
    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 concerned3
    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 No
    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
    The end of trial will be when the last patient has completed treatment and has been assessed for the 52 week visit and all questionnaires have been completed.ie.LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days2
    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: 60
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state60
    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 study treatment is complete patients who are well will be referred back to their GP. Patients who are not well and require ongoing care will be referred to the appropriate NHS provider. Recommendations for continued provision of interventions will be given to the ongoing healthcare provider.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-07
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