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    Summary
    EudraCT Number:2009-013420-23
    Sponsor's Protocol Code Number:F1J-US-HMGO
    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:2009-09-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-013420-23
    A.3Full title of the trial
    Neurobiological Correlates of Antidepressant Response After Duloxetine Hydrochloride Treatment in Subjects with Major Depressive Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brain imaging and clinical markers in MDD subjects treated with duloxetine
    A.3.2Name or abbreviated title of the trial where available
    HMGO
    A.4.1Sponsor's protocol code numberF1J-US-HMGO
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01051466
    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 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 supportEli Lilly & Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly & Company
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Addressna
    B.5.3.2Town/ cityna
    B.5.3.3Post codena
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    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
    D.3.2Product code LY248686
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    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 INNDULOXETINE HYDROCHLORIDE
    D.3.9.1CAS number 136434-34-9
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major depressive disorder
    E.1.1.1Medical condition in easily understood language
    Depression
    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.1.3Condition 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 determine if duloxetine 60-120 mg given orally once daily (QD) for 12 weeks will result in changes in amygdalae activation (average of right and left amygdalae) in response to implicit sad facial affect processing in subjects with MDD from Week 0 (Visit 2) (baseline/medication-free) to Week 12 (endpoint) when compared with healthy control subjects, as assessed by the change in the fMRI mean blood-oxygenation-level-dependent (BOLD) response.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    • Neuroimaging Correlates: to examine if changes in (1) anterior cingulate activation and volume and (2)amygdalae activation and volume predict remission
    (3) have diagnostic potential
    • Molecular and Cellular Correlates:
    4. translocation of Gsα from lipid rafts
    5. Gsα-activated adenylyl cyclase
    6. if change in Gsα-activated adenylyl cyclase correlates with translocation of Gsα from lipid rafts
    7. Gsα localization and adenylyl cyclase
    8. changes in BDNF, proBDNF and their receptors
    9. changes in proinflammatory cytokines
    • Clinical Measures and Outcome:
    10. Change in clinical outcome from Week 0 to Week 12, as assessed by:
    a. Remission
    b. Response
    11. change in the SDS
    12. effects of treatment on other clinical outcomes
    13. safety and tolerability during the 12-week open-label period

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    MDD subjects are eligible to be included in the study only if they meet all of the following criteria:
    [1] Male or female outpatients at least 25 to 65 years of age that are right-handed.
    [2] Be able to comprehend the nature of the planned investigation and communicate intelligibly with the investigator and study coordinator. Have the capacity to sign the ICD.
    [3] Have signed the study ICD prior to any additional study procedures and after being informed of the study drug and procedures used in this study.
    [4] Meet the criteria for single episode or recurrent MDD, without psychotic features, as defined by the DSM-IV-TR and confirmed by SCID-IV, without co-morbid DSM-IV Axis I or II disorder.
    [5] Be free of their current antidepressant medication for a minimum of 6 weeks for fluoxetine treatment or of 4 weeks of other antidepressant treatment before start of study medication at Visit 2 (baseline).
    [6] Have a HAMD17 total score of ≥18 at Visits 1 and 2.
    [7] Judged to be a reliable study participant, and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.
    [8] Agree not to participate in any other research trial or study while enrolled in this study.
    [9] Female subjects: Women of child-bearing potential must have negative urine pregnancy tests prior to enrollment (Visit 2) and agree to use a reliable method of birth control during the study.
    Healthy control subjects will be matched by age, gender, and IQ to subjects with MDD (group-matched). To meet the inclusion criteria for the study, healthy controls must have a HAMD17 total score of < or =7 at Visits 1 and 2 and must not meet the criteria for MDD based on the SCID-IV. Healthy controls should also meet inclusion criteria [1], [2], [3], [7] and [8].
    E.4Principal exclusion criteria
    MDD subjects and healthy controls will be excluded from the study if they meet any of the following criteria:
    [10] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    [11] Are Lilly employees.
    [12] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    [13] Treatment within the last 30 days with a drug that has not received regulatory approval at the time of study entry.
    [14] Have previously completed or withdrawn from this study or any other study investigating duloxetine after receiving study drug. (Note: Subjects who have been previously screened for any duloxetine study including this study and never received study drug will be eligible for this study if they meet all current entry criteria.)
    [15] Have a history of substance abuse or dependence within the past 6 months (drug categories defined in the DSM-IV-TR), excluding nicotine and caffeine.
    [16] A positive urine drug screen for any substances of abuse or dependence.
    Note: In the case of a positive urine drug screen, in the opinion of the investigator, the investigator may follow-up with the Lilly clinical research physician/scientist for inclusion into the study
    [17] Have any current (within the past 6 months) DSM-IV-TR co-morbid Axis I or II disorder as determined by patient history or investigator assessment.
    [18] Have any history of bipolar disorder, a primary psychotic disorder (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder), known Alzheimer’s disease or mental retardation, or obsessive-compulsive disorder as determined by patient history or investigator assessment.
    [19] Pregnant women, women who are breast-feeding, or women of childbearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse or have been surgically sterilized (for example, abstinence, intrauterine device, oral contraceptive, implant, Depo-Provera®, or barrier devices).
    [20] Are judged by the investigator to have serious suicidal risk or risk of self-harm.
    [21] Have a history of recurrent self-mutilation or self-harm.
    [22] Have uncontrolled narrow-angle glaucoma.
    [23] Have been diagnosed with an acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
    [24] Have end-stage renal disease, a prior renal transplant, current renal dialysis, or severe renal impairment.
    [25] Have abnormal thyroid-stimulating hormone (TSH) concentration. (Note: Subjects previously diagnosed with hyperthyroidism or hypothyroidism who have been treated on a stable dose of thyroid supplement for at least 3 months, have medically appropriate TSH concentrations and are clinically euthyroid, and are otherwise determined to be medically appropriate for study participation by the investigator are allowed.)
    [26] Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within the past year.
    [27] Initiating psychotherapy within 6 weeks prior to study entry or during study participation, stopping, or changing psychotherapy after study entry.
    [28] Have frequent and/or severe allergic reactions with multiple medications, or known allergic reactions to the study medication.
    [29] Known hypersensitivity to duloxetine or any of the inactive ingredients.
    [30] Lack of response of the current episode 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 subject meets criteria for treatment-resistant depression.
    [31] Known human immunodeficiency virus (HIV) and other medical disorders that are known to affect central nervous system (CNS) structures or function as assessed by the investigator (for example, CNS neoplasms, neurosyphilis).
    [32] Have a medical illness, clinically significant laboratory abnormality, or is
    taking a CNS active medication that, in the opinion of the investigator, might
    interfere with study participation (for example, is likely to require
    hospitalization) or that, in the opinion of the investigator, might interfere with
    the interpretation of the primary endpoint (for example, hypertension or
    diabetes).
    [33] Are unwilling or unable to comply with the study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Anterior cingulate and amygdalae activation in response to implicit sad facial affect processing will be measured by fMRI measurement, the percentage signal change from baseline task (neutral faces) to experimental task (sad faces) in BOLD response. The primary analysis is to test the null hypothesis that the mean change in fMRI from baseline (Week 0) to Week 12 for MDD group equals that for the healthy control group - versus the alternative that the mean changes from baseline are not equal. The primary analysis will be conducted on the full analysis set.
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 14 weeks
    E.5.2Secondary end point(s)
    Evaluation of neuroimaging and its correlation with changes in biomarkers, changes in clinical data and measures of anxiety and depression. Safety will also be assessed by monitoring adverse events, clinical signs and suicide ideation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 14 weeks
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Healthy subjects (control group): These subjects will not receive study drug.
    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
    Healthy subjects (control group): These subjects will not receive study drug.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    Last patient last visit
    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 months1
    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 months1
    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.1.2.1Number of subjects for this age range: 59
    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 Yes
    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 state59
    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)
    Patients will return to standard of care. There is no guarantee they will be able to remain on study drug.
    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 Decision2009-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-05
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    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.

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