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    Summary
    EudraCT Number:2007-001071-11
    Sponsor's Protocol Code Number:11918A
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-001071-11
    A.3Full title of the trial
    Randomised, double-blind, parallel-group, placebo-controlled, duloxetine referenced, dose-finding study of Lu AA24530 in Major Depressive Disorder
    A.4.1Sponsor's protocol code number11918A
    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 SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    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 No
    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 nameLu AA24530
    D.3.2Product code Lu AA24530
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeLu AA24530
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5, 10, 2 x 10
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 holderBoehringer Ingelheim International GmbH Allemagne
    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.3.4Pharmaceutical form 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30, 60
    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 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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    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 this study is to prove efficacy of one or more doses of Lu AA24530 relative to placebo.
    E.2.2Secondary objectives of the trial
    Compare the efficacy of Lu AA24530 to that of pbo in terms of proportion of pts with:
    - response after 6 wks of tt,
    - remission after 6 wks of tt,
    - response after 14 days of tt that is maintained or further improved at week 6.
    Compare the efficacy of Lu AA24530 to that of pbo in terms of change from Baseline on the total MADRS score during the course of the study.
    Assess the safety and tolerability of Lu AA24530.
    Analyse exploratorily the population PK of Lu AA24530 and its metabolite Lu AA37208 in depressed pts and to evaluate any relationship between exposure and efficacy, tolerability, and safety.
    Evaluate the efficacy of Lu AA24530 on the subpopulations of pts with MDD with melancholic- and atypical features.
    Evaluate the effect on pain, cognitive deficits and on Health Related QoL of Lu AA24530.
    Conduct exploratory analyses of biomarkers to better understand the pathophysiology of MDD and the treatment response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patient is able to read and understand the Patient Information Sheet.
    The patient has signed the Informed Consent Form.
    The patient has a Major Depressive Episode (MDE), diagnosed according to DSM-IV-TR criteria (classification code 296.xx) and confirmed according to the Mini-International Neuropsychiatric Interview (MINI) .
    The patient is a man or a woman, aged between 18 and 65 years (extremes included).
    The patient has a Major Depressive Episode that has lasted at least 3 months.
    The patient has a MADRS of total score ≥ 26.
    The patient is able to swallow capsules.
    The patient, if female, must: agree not to try to become pregnant during the study, AND use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), OR have had her last natural menstruation at least 24 months prior to Baseline, OR have been surgically sterilised prior to Baseline, OR have had a hysterectomy prior to Baseline, OR not be sexually active.
    E.4Principal exclusion criteria
    The patient has one or more of the following conditions: Any current psychiatric disorder established as the principal diagnosis other than MDD as defined in the DSM-IV-TR and assessed with the Mini-International Neuropsychiatric Interview (MINI), current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR, any substance use disorder (except nicotine) within the previous 6 months as defined in the DSM-IV-TR, presence or history of a clinically significant neurological disorder, any axis II disorder that might compromise the study.
    The patient is at significant risk of suicide either corroborated by MINI item A3g, a score ≥5 on item 10 on the MADRS (Item No. 10 named "Suicidal Thoughts"), a score ≥3 on item 3 on the HAM-D-17 with MES (Item No. 3 named "Suicidal impulses"), or according to investigator’s opinion.
    The patient has a Major Depressive Episode that has been unresponsive to two adequate courses of antidepressant treatment of each at least 6 weeks duration.
    The patient has a history of lack of response to previous treatment with duloxetine.
    The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to duloxetine.
    The patient has received electroconvulsive therapy within 6 months prior to Baseline.
    The patient used/uses disallowed recent or concomitant medication (specified in Appendix II) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
    The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
    The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance.The patient has increased intra-ocular pressure or is at risk of acute narrow-angleglaucoma.The patient has a chronic liver disease.
    The patient has abnormal vital signs judged by the investigator to be indicative of significant illness.
    The patient has a history of seizures.
    The patient has a history of renal illness or damage or decreased renal function.
    The patient has one or more laboratory values outside the normal range, based on the blood samples taken at the Screening Visit, that are considered by the investigator to be indicative of significant illness.
    The patient has a thyroid-stimulating hormone (TSH) out of normal range
    The patient has an abnormal ECG judged by the investigator to be indicative of significant illness.
    The patient has a QTc above 450 ms.
    The patient has a history of hypokalaemia.
    The patient has a family history of Long QT Syndrome.
    The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
    The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to Baseline.
    The patient has a positive urine drug screen.
    The patient is pregnant or breast-feeding.
    The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
    The patient is a member of the site personnel or their immediate families.
    The patient has previously participated in this study.
    The patient has previously been exposed to Lu AA24530
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of interest is MADRS total score at Week 6.
    Secondary endpoints are MADRS total score at all time points, MADRS remission and response after 6 weeks and MADRS sustained response after 2 weeks. Also safety and tolerability measured by vital signs, ECGs, laboratory measurements, weight, adverse events and withdrawal rates, are considered as secondary endpoints.
    In addition HAM-D-17, CGI-I, CGI-S, SF-36, pain assessments, and cognition outcomes will be analysed at all time points (where rated).
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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.1.1.1In 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) Yes
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 625
    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 Decision2007-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-26
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