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    Summary
    EudraCT Number:2004-000167-95
    Sponsor's Protocol Code Number:Protocol F1J-MC-HMDI
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-000167-95
    A.3Full title of the trial
    Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
    A.4.1Sponsor's protocol code numberProtocol F1J-MC-HMDI
    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 Limited
    B.1.3.4CountryUnited Kingdom
    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 Nederland BV
    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 hydrochloride
    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 136434-34-9
    D.3.9.2Current sponsor codeLY24 86 86
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10025454
    E.1.2Term Major depressive disorder, recurrent episode
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess the efficacy of duloxetine 60 mg to 120 mg once daily (QD) compared with placebo in the prevention of depressive recurrences, as measured by time to recurrence, among patients with recurrent major depressive disorder (MDD) who have responded to duloxetine during a 4- to 10-week acute treatment period and a 22- to 24-week continuation treatment period.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of maintenance treatment with duloxetine compared with placebo as measured by: Recurrence rates, Time to >= 50% worsening in the 17-item HAMD17 and CGI-Severity >=3, Loss of response (HAMD17 >9 and CGI-Severity >2) at any time, HAMD17 total score, CGI-Severity scale, PGI-Improvement scale, HAMD subscales. -To assess the efficacy of maintenance treatment with duloxetine compared with placebo on quality of life and health outcome measures, as measured by: Sheehan Disability Scale (SDS), 36-item Short-Form Health Survey (SF-36), Resource Utilization and Hospitalization Module. To evaluate the safety and tolerability of maintenance treatment with duloxetine compared with placebo as measured by: TEAEs, Vital signs, Laboratory, Measurements, Arizona Sexual Experience Scale (ASEX). To assess the efficacy and safety of duloxetine during the 4- to 10-week, open-label, acute phase and the 22- to 24-week continuation phase, using the above measures (if applicable).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients may be included in the study only if they meet all of the following criteria:
    Are male or female outpatients at least 18 years of age, have signed and dated the informed consent document (ICD), Meet criteria for recurrent major depressive disorder (MDD), without psychotic features, as defined by DSM-IV and as assessed by the MINI, Must have had at least three episodes of depression, including the current episode, within the past 5 years, Were in remission between episodes of depression in the opinion of the investigator, and have been stable and off antidepressant medication for at least 2 months prior to the onset of the current episode, Have a HAMD17 total score of >=18 at Visits 1 and 2, Have a CGI-Severity score of >=4 at Visits and 2, Have a level of understanding sufficient to provide informed consent and to communicate with the investigators and site personnel, Are judged to be reliable, agree to keep all appointments as required by the protocol.
    E.4Principal exclusion criteria
    Patients must be excluded from the study for any of the following criteria: Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study; Are employed by Lilly or Boerhinger Ingelheim (BI). Immediate family of Lilly or BI employees may participate in Lilly or BI-sponsored clinical trials, but are not permitted to participate at a Lilly or BI facility; Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry; Have previously completed or withdrawn from this study or any other study investigating duloxetine; Have any current and primary Axis I disorder other than MDD, including but not limited to dysthymia; Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders; Have any anxiety disorder as a primary diagnosis within the past year (including panic disorder, agoraphobia, obsessive-compulsive disorder [OCD], posttraumatic stress disorder [PTSD], generalized anxiety disorder [GAD], and social phobia, but excluding specific phobias); Have the presence of an Axis II disorder, which, in the judgment of the investigator, would interfere with compliance with the study protocol; Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine; Have a positive urine drug screen for any substances of abuse, including benzodiazepines (at Visit 1). Note: If the patient has a positive drug screen at Visit 1, a retest may be performed prior to Visit 2 if, in the judgment of the investigator, there is an acceptable explanation for the positive result. If the retest is positive for active metabolites, the investigator must document that the patient has discontinued taking the medication. If the retest is positive for the parent compound, the patient will be excluded; Are women who are pregnant or breastfeeding and women of childbearing potential who are not using a medically-accepted means of contraception when engaging in sexual intercourse (for example, intrauterine device, oral contraceptive, implant, Depo-Provera, barrier devices with spermicide, or abstinence); Demonstrate lack of response of the current episode of MDD to two or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression; Are patients judged to be at serious suicidal risk in the opinion of the investigator, and/or if the patient’s HAMD17 score on Item 3 Suicide is >3 at Visit 1 and Visit 2; Have serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require intervention/hospitalization/excluded medication during the course of the study; Have had electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the past year; Have initiated or stopped psychotherapy within 6 weeks prior to enrollment or at any time during the study. Patients who initiate psychotherapy more than 6 weeks before enrollment may continue in therapy if, in the investigator's judgment, the therapy is not in its active phase. This judgment may be made by inquiring whether there has been a change in the frequency of visits at the time of study enrollment, a stressful event, or change in the patient's symptomatology; Are taking any excluded medications within 7 days prior to Visit 2; Have been treated with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 or potential need to use a MAOI within 5 days after discontinuation of study drug; Have been treated with fluoxetine within 30 days prior to Visit 2; Have frequent and/or severe allergic reactions with multiple medications or known allergic reactions to duloxetine; Have abnormal thyroid-stimulating hormone (TSH) concentrations, based on the performing laboratory’s reference ranges; Note: Patients previously diagnosed with hyperthyroidism or hypothyroidism who have been treated on a stable dose of thyroid supplement for at least the past 3 months, have medically appropriate TSH concentrations, and are clinically euthyroid are allowed; Have serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness; symptomatic peripheral vascular disease; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study; Have end-stage renal disease and are undergoing dialysis; Patients with uncontrolled narrow-angle glaucoma; Have acute hepatic injury (such as hepatitis) or severe (Child-Pugh Class C) cirrhosis; Known hypersensitivity to duloxetine or any of the inactive ingredients.
    E.5 End points
    E.5.1Primary end point(s)
    The measure for the primary objective is the time to recurrence as assessed during 52 to 54 weeks of maintenance treatment, in patients who have responded to up to 34 weeks of open-label duloxetine treatment (4 to10 weeks of acute treatment plus 22 to 24 weeks of continuation treatment). “Time to recurrence” is defined as the time from random assignment to the first visit during the maintenance phase at which the patient meets the recurrence criteria.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    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 years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-06-01. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 500
    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 Decision2005-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-23
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