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    Summary
    EudraCT Number:2008-001829-33
    Sponsor's Protocol Code Number:F1J-US-HMFA
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-10-21
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2008-001829-33
    A.3Full title of the trial
    Duloxetine Versus Placebo in the Long-Term Treatment of Patients with Late-Life Major Depression
    A.3.2Name or abbreviated title of the trial where available
    HMFA
    A.4.1Sponsor's protocol code numberF1J-US-HMFA
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisation
    B.5.2Functional name of contact point
    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 Cymbalta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDuloxetine
    D.3.2Product code LY248686
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDULOXETINE
    D.3.9.1CAS number 116539594
    D.3.9.2Current sponsor codeLY248686
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboGastro-resistant capsule, 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 elderly patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012378
    E.1.2Term Depression
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of duloxetine 60 mg once daily (QD) to placebo on depression after 13 weeks of double-blind treatment utilizing clinician-rated measurement of the Maier Subscale score of the Hamilton Depression Rating Scale (HAMD17) in elderly patients (≥ 65 years of age) who meet criteria for MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and who have had at least one previous MDD episode
    E.2.2Secondary objectives of the trial
    To compare the efficacy of duloxetine 60 mg QD to placebo after 13 weeks
    of double-blind treatment as measured by the mean change from baseline in
    the learning trial score and delayed recall score of the Verbal Learning and
    Recall Test (VLRT).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Are male or female outpatients at least 65 years of age.
    [2] Sign the informed consent document.
    [3] Meet criteria for major depression as defined by the Diagnostic and
    Statistical Manual of Mental Disorders, Fourth Edition Text Revision
    (DSM-IV-TR) (American Psychiatric Association. 1994).
    [4] Have a MADRS total score of at least 20 at Visits 1 and 2.
    [5] Have a MMSE score of at least 20 at Visit 1.
    [6] Have had at least one prior episode of MDD as defined by DMS-IVTR.
    [7] Have a degree of understanding such that the patient can communicate
    intelligibly with the investigator and study coordinator.
    [8] Are judged to be reliable and agree to keep all appointments for clinic
    visits, tests, and procedures required by the protocol (including use of
    an automated voice response system) and are able to swallow all
    required medication without opening or crushing.
    [9] Agree not to participate in any other research trial or study while
    enrolled in this study.
    E.4Principal exclusion criteria
    [10] Are investigator site personnel directly affiliated with the study, or are
    immediate family of investigator site personnel directly affiliated with
    the study.
    [11] Are employed by Lilly
    [12] Have received treatment with a drug within the last 30 days that has
    not received regulatory approval at the time of study entry.
    [13] Are persons who have previously completed or withdrawn from this
    study or any other study investigating duloxetine for the treatment of
    depression.
    [14] Have any prior history of bipolar disorder, panic disorder, psychosis,
    schizophrenia, or obsessive-compulsive disorder.
    [15] Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
    [16] Have moderate to severe dementia.
    [17] Have a mental retardation diagnosis or the presence of any other Axis
    II disorder that, in the judgment of the investigator would interfere
    with the study compliance.
    [18] Patients judged clinically to be at serious suicidal risk in the opinion of
    the investigator.
    [19] Have a history of substance abuse or dependence within the past 6
    months (drug categories defined in the DSM-IV), excluding nicotine
    and caffeine.
    [20] Have a positive urine drug screen for any substances of abuse.
    [21] Lack of response of the current episode of major depression to two or
    more adequate courses of antidepressant therapy with an adequate
    medication trial defined as a score of > 3 on the Antidepressant
    Treatment History Form. This tool is provided to sites with the
    protocol.
    [22] Have a history of a lack of response, at any time, to an adequate trial
    of duloxetine for the treatment of MDD (defined as treatment with at
    least 60mg/day of duloxetine for a minimum of 4 weeks).
    [23] Have a serious medical illness or clinically significant laboratory
    abnormality that is not stabilized or is anticipated to require
    hospitalization within 6 months, in the opinion of the investigator.
    [24] At Visit 1 an ALT, AST, or GGT >3 times upper limit of normal
    (ULN), based on Study Central Laboratory reference ranges.
    [25] Have been diagnosed with an acute liver injury or
    severe cirrhosis
    [26] Have a prior renal transplant, current renal dialysis, or serum
    creatinine laboratory value > 1.5 times upper limit of normal (ULN)
    [27] Are taking any excluded medications within 7 days prior to Visit 2 with the exception of fluoxetine which cannot be taken within 30 days prior to Visit 2.
    [28] Treatment with a monoamine oxidase inhibitor (MAOI) within 14
    days prior to Visit 2 or have the potential need to use an MAOI during
    the study or within 5 days of discontinuation of study drug.
    [29] Have frequent and/or severe allergic reactions to multiple medications,
    or known allergic reactions to any of the study drugs.
    [30] Known hypersensitivity to duloxetine or any of the inactive
    ingredients.
    [31] Patients with uncontrolled narrow-angle glaucoma.
    [32] Have abnormal thyroid-stimulating hormone (TSH) concentration.
    [33] Have discontinued hormone replacement therapy within the previous 3
    months.
    [34] Have had electroconvulsive therapy (ECT) or transcranial magnetic
    stimulation (TMS) within the past year.
    E.5 End points
    E.5.1Primary end point(s)
    The HAMD17 (Hamilton 1960, 1967) is a widely used observational rating measure of
    depression severity. The HAMD17 will be clinician-administered and used to assess the severity of depression and its improvement during the course of therapy. The HAMD17 total score ranges from 0 (not at all depressed) to 52 (severely depressed).
    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 Yes
    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 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.8.3 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 concerned7
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months5
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients leaving in nursing home residence
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 300
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
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