Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-000547-27
    Sponsor's Protocol Code Number:CTIMPMCRENAL12
    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:2012-08-21
    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 number2012-000547-27
    A.3Full title of the trial
    A Pilot Randomised Controlled Trial of Drug Treatment for Depression in Patients undergoing Haemodialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Pilot Randomised Controlled Trial of Drug Treatment for Depression in Patients undergoing Haemodialysis
    A.3.2Name or abbreviated title of the trial where available
    ASSertID - A Study of Sertraline In Dialysis - Version 1
    A.4.1Sponsor's protocol code numberCTIMPMCRENAL12
    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 SponsorEast and North Hertfordshire NHS 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 pointDr Karin Friedli
    B.5.3 Address:
    B.5.3.1Street AddressClicir, University of Hertfordshire
    B.5.3.2Town/ cityHealth Research Building
    B.5.3.3Post codeAL10 9AB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01707286472
    B.5.5Fax number01707286388
    B.5.6E-mailk.friedli1@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 support
    B.4.2Country
    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 pointDr Karin Friedli
    B.5.3 Address:
    B.5.3.1Street AddressClicir, University of Hertfordshire
    B.5.3.2Town/ cityHealth Research Building
    B.5.3.3Post codeAL10 9AB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01707286472
    B.5.5Fax number01707286388
    B.5.6E-mailk.friedli1@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 Sertralin - 1 A Pharma® 50 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderRoyal Free Hampstead NHS Trust
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule
    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.3.9.2Current sponsor codeCTIMPMCRENAL12
    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 100
    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
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder in Patients with End Stage Renal Disease
    E.1.1.1Medical condition in easily understood language
    Depression in patients with kidney disease
    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 10025453
    E.1.2Term Major depressive disorder NOS
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066623
    E.1.2Term Chronic haemodialysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10014647
    E.1.2Term End stage renal failure
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    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 evaluate the feasibility of conducting a randomised, double blind, placebo pilot trial in patients with end stage renal disease (ESRD) and depression. The treatment under investigation is Sertraline, a licensed anti-depressant. The study is split into four phases. Phase one will evaluate the number of ESRD patients eligible for this clinical trial. Phase two will assess the feasibility of conducting a randomised drug trial in this group of patients, by measuring the number who take part. Phase three will look at the safety and drug exposure of Sertraline in ESRD patients and phase four will explore the patient experience of participating in this trial.
    E.2.2Secondary objectives of the trial
    The secondary research questions will atttempt to quantify the variability in the outcome measures (including quality of life) for the treatment and placebo arms, allowing an assessment of effect sizes, effects of treatment centre, and bias due to missing data. The study will also try to evaluate the gain in the outcome measures in treated patients compared to those in the control group and whether changes in these measures over time can be attributed to treatment. This is a pilot study and a statistically significant outcome in this domain is unlikely. Establishing the effect size though will be of crucial importance in powering future definitive trials.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For the prevalence and screening part of the study the inclusion criteria are: 1)Patients with ESRD and on haemodialysis. They will have started dialysis at least 3 months previously and have continued to receive dialysis in the 3 months prior to the invitation to participate in this study. 2)Adults aged 18 or over. 3)Patients who speak and read English sufficiently well to complete questionnaires. For the clinical trial part of the study the inclusion criteria are: 4)Patients with a BDI II score of 16 or above. 5)Patients, who according to the nephrologist, have more than one year prognosis. 6)Patients with a diagnosis of Major Depressive Disorder according to a DSM IV interview conducted by a psychiatrist. 7)Patients who score 18 or above on the Montgomery-Åsberg Depression Rating Scale (MADRS).
    E.4Principal exclusion criteria
    The exclusion criteria for the clinical trial are: 1)Patients who are currently being or have been treated for depression and/or anxiety with any antidepressants in the last 3 months. 2)Patients who are currently being or have been treated for depression and/or anxiety with a formal psychological therapy in the last 3 months. 3)Patients who are awaiting a planned living donor transplant within the period of the trial. 4)Patients who have less than a year survival prognosis according to the nephrologist. 5)Patients for whom Sertraline is contraindicated by their existing drug regimen according to the Summary of Product Characteristic. 6)Patients with hepatic impairment, whose serum level of Alanine transaminase (ALT) is 2 times the upper limits of normal or higher. 7)Patients who have hepatitis B or hepatitis C, HIV/AIDS, and/or Creutzfeldt-Jakob disease. 8)Patients who are pregnant or of childbearing potential who are not using adequate contaception. 9)Patients who are or have been involved in an intervention study in the last 3 months. 10)Patients’ with impaired coagulation judged by an International normalised ratio (INR) greater than 1.3. 11)Patients who are currently taking MAOIs or pimozide. 12)Patients who are currently taking triptans, antipsychotics, dopamine antagonists, tramadol, linezolid, and warfarin. 13)Patients at moderate to severe risk of self-harm according to the assessment of the study psychiatrist. 14)Patients who score above 4 on item 10 on the MADRS. 15)Patients who answer yes to question A3G on the Mini-International Neuropsychiatric Interview (MINI) . 16)Patients who have other known psychiatric condition, including substance misuse, psychosis, or personality disorder.
    E.5 End points
    E.5.1Primary end point(s)
    Our primary outcome for the study is the proportion of eligible patients approached who agree to enter the study and complete the study. In addition, for phase one, are main outcome is the number of people on haemodialysis who screen positive on the Beck Depression Inventory II. For phase three, to measure plasma levels of Sertraline in pre and post dialysis patients and phase four to explore the patients' views regarding the facilitators and barriers to participation in the trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The pilot trial is 6 months long and the primary endpoint will be evaluated at 6 months.
    E.5.2Secondary end point(s)
    There are a number of secondary outcomes. For phase one, we are interested in the eligibility of patients into this phase, looking at the number of haemodialysis patients that score positive on the Patient Health Questionnaire 9 and compare these scores with the Beck Depression Inventory II scores. For phase two, our secondary outcome measures are: 1) The proportion of patients who score positive on the BDI-II and are eligible for the psychiatric diagnostic interview. 2) The number of and reasons for patients not meeting the initial eligibility criteria applied by the CI/PIs in the trial outcome and safety and drug exposure phases. 3) The proportion of interview eligible patients who agree to take part in the psychiatric diagnostic interview. 4) The proportion of interview eligible patients who choose not to take part in the psychiatric diagnostic interview and reasons given (as well as alternative care chosen). 5) The proportion of patients who are diagnosed with a major depressive disorder according to the psychiatric diagnostic interview. 6) The proportion of eligible patients who agree to take part in the trial outcome and safety and drug exposure phases. 7) The proportion of eligible patients who refuse to take part in the trial outcome and safety and drug exposure phases and the reasons given (including description of alternative health options chosen). 8) The proportion of recruited patients who withdraw from the trial outcome and safety and drug exposure phases, the stage of withdrawal and the reason(s) for withdrawal. 9) The number of recruited patients who complete the baseline assessment. 10) The number of recruited patients who complete the follow-up assessments. 11) The proportions of complete and missing data, and the characteristics of the missing data. 12) The number, range and extent of adverse events reported. 13) To quantify the variability in the outcome measures (including QoL) for the treatment and placebo arms, allowing an assessment of effect sizes, effects of treatment centre, and bias due to missing data. 14) To evaluate the gain in the outcome measures in treated patients compared to those in the control group and whether changes in these measures over time can be attributed to treatment. For phase 3, our secondary aims are: 1) To compare the plasma Sertraline levels with clinical effectiveness (such as the Montgomery-Åsberg Depression Rating Scale, MADRS). 2) To compare the plasma Sertraline levels with AEs. For phase 4 are additional aims are: 1) To explore the views of patients regarding taking additional medication and the effects of the medication on them. 2) To explore the views of patients about the applicability and understanding of the measures/instruments used.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For phase one, there is only one timepoint. For the other phases of the study the time point is 6 months.
    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 No
    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 Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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 concerned4
    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
    We have two definitions for end of trial. The first definition of end of trial is LVLS. The data will be locked at this point. The second end of trial, is when the Sertraline samples are sent to the Cardiff Toxicology Laboratory, analysed and added to the data file. This will take place about 6 to 8 months after the LVLS. The data file will be unlocked and the additional data added.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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)
    At the end of the 6 months, when the patient has had their final assessment with the psychiatrist and the research nurse, the patient will be advised to titrate down the Sertraline or placebo. For patients on 100 mg, they will be advised to take 50 mg for 1 week, then take 50 mg on alternate days for 1 week, and then stop taking the study medication…
    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 Decision2012-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-20
    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.

    European Medicines Agency © 1995-Sun Apr 28 06:50:50 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA