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    Summary
    EudraCT Number:2007-006609-25
    Sponsor's Protocol Code Number:MOOD-HF
    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:2008-03-27
    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 number2007-006609-25
    A.3Full title of the trial
    Effects of selective serotonin re-uptake inhibition on morbidity, mortality and mood in Depressed Heart Failure patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of an antidepressant drug on morbidity, mortality and mood in Depressed Heart Failure patients
    A.3.2Name or abbreviated title of the trial where available
    MOOD-HF
    A.4.1Sponsor's protocol code numberMOOD-HF
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN33128015
    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 SponsorJulius Maximilians Universität Würzburg
    B.1.3.4CountryGermany
    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 supportBMBF / DFG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Würzburg
    B.5.2Functional name of contact pointDeutsches Zentrum für Herzinsuffizi
    B.5.3 Address:
    B.5.3.1Street AddressStraubmühlweg 2a
    B.5.3.2Town/ cityWürzburg
    B.5.3.3Post code97078
    B.5.3.4CountryGermany
    B.5.4Telephone number++4993120146361
    B.5.5Fax number++49931201646360
    B.5.6E-mailAngermann_C@ukw.de
    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 Cipralex 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameCipralex
    D.3.4Pharmaceutical form Tablet
    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 INNESCITALOPRAM
    D.3.9.3Other descriptive name(S)-1-(3-Dimethylaminopropyl)- 1-(4-fluorphenyl)-1,3- dihydro-2- benzofuran-5-carbonitril
    D.3.9.4EV Substance CodeSUB16425MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    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 placeboTablet
    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
    To investigate the effects of selective serotonin re-uptake inhibition with the SSRI escitalopram on morbidity and mortality in depressed patients with CHF. The primary endpoint is the time to a first clinical event, either death or unplanned hospitalisation, whichever occurs first, for any reasons.
    E.1.1.1Medical condition in easily understood language
    To investigate the effects of an antidepressant drug on morbidity and mortality in depressed patients with chronic heart failure.
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    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 investigate the effects of treatment with the SSRI escitalopram compared to placebo on morbidity and mortality in CHF patients with a current episode of major depression
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are:
    Major: To estimate the improvement of depression by escitalo-pram compared to placebo in depressed CHF patients. To assess whether possible reduction of morbidity and mortality (see primary objective) might be attributable to the improvement of depression.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. SCREEN-MOOD
    Objective: To determine the prevalence and positive predictive value of PHQ-9 sum 11 in patients with systolic CHF of NYHA class >=II in a large cohort. To describe the correlation of PHQ-9 sum and its positive predictive value with patients gender, age and NYHA class.
    Patients: All subjects entering screening step 1

    2. THROMBO-MOOD
    Objective: To determine the effect of the SSRI escitalopram on platelet activation in depressed patients with CHF.
    Patients: Consecutive subjects entering screening step 1 at the Center of Würzburg (expected number: n= 60)
    Additional data required: Markers of platelet activation comprise platelet surface expression of P-selectin and CD40 ligand, binding of fibrinogen to activated glycoprotein IIb/IIIa on the plate-let surface, and measurement of circulating platelet/leucocyte and platelet/monocyte aggre-gates. Whole blood will be sampled at baseline and after 6 months of therapy, immediately incubated with the respective antibodies and fixed. Flow cytometry will be performed within the next hours on the same day.

    3. VASO-MOOD
    Objective: Vasoreactivity of large vessels is an accepted surrogate to monitor favourable and detrimental effects of pharmacotherapy on the atherosclerosis risk profile. We aim to deter-mine the effect of the SSRI escitalopram on endothelium-dependent and -independent vasoreactivity, large artery stiffness and pulse wave reflection in depressed patients with CHF and to investigate concurrent changes with markers of inflammation (see substudy THROMBO-MOOD) and heart failure severity.
    Patients: All subjects entering screening step 1 at the Center of Würzburg (expected number: n=100).

    4. GENE-MOOD
    Objectives: a) to determine whether selected polymorphisms in candidate genes are associated with an increased risk for depression in CHF. Emphasis will be placed on candidate genes which have already been linked to depression and CHF (e.g., ACE or NOS3). b) to investigate whether polymorphisms in candidate genes affect plasma levels of escitalopram (pharmacogenomics, -kinetics). c) to test whether polymorphisms in candidate genes impact on the therapeutic response towards escitalopram (pharmacogenomics, -dynamics). The panel of candidate genes focuses on functional polymorphisms in the serotonergic system (e.g., the serotonin transporter 5HTT, 5HT2a, and p11).
    Patients: All subjects.
    Additional data required: DNA specimens (extracted from blood at the Center of Würzburg). Subsequently, candidate gene polymorphisms are determined by PCR and MALDI-TOF tech-niques.

    5. OSMO-MOOD
    Objectives: a) to examine whether antidepressant medication with escitalopram modifies the water and sodium homeostasis in subjects with heart failure and comorbid depression along the trial, and to estimate the prognostic utility of markers involved in the osmo- and volume regulation as serum sodium, urine osmolality, fractional excretion of sodium and uric acid, co-peptin; b) to examine associations between severity of depression and anxiety (MADRS, PHQ-9, GAD-7), severity of heart failure (NYHA functional class, NT-proBNP levels) and the above described panel of markers of water and sodium homeostasis
    Patients: All subjects
    Additional data required: Copeptin measurement (determined from samples stored at the Center of Würzburg).

    6. Fe-MOOD
    Objectives: We want to investigate the role of iron deficiency as predisposing factor and the prognostic relevance on morbidity and mortality of patients with heart failure and depression.
    Patients: All subjects
    Additional data required: measurement of Fe, Ferritin, Transferrin and iron binding capacity at baseline, 6, 12, 18 and 24 months (determined from routine blood samples in following visits or blood samples stored at the Center of Würzburg)
    E.3Principal inclusion criteria
    Patients must meet ALL of the following criteria:
    • Age >= 18 years
    • Chronic systolic heart failure of any etiology with
    - current NYHA class II-IV and
    - at least one measurement of LVEF < 45% by echocardiography or laevocardio-graphy or cardio-MRT within the preceding three months
    • Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of current major DEP based on the Structured Clinical Interview for DSM-IV (SCID48).
    • Provision of written informed consent.
    E.4Principal exclusion criteria
    • Recent history of acute myocardial infarction (<3 months)
    • Acute cardiac decompensation
    • Recent (< 3 months) or planned major cardiac surgery (<12 months)
    • Advanced renal failure (MDRD < 30ml/min)
    • Moderate or severe hepatic insufficiency (plasma levels of serum transaminases >threefold of the upper level of the normal range) or manifest hepatic failure
    • Thyreotoxicosis
    • Other medical contraindication against treatment with SSRI
    • Significantly reduced life expectancy due to other comorbidity (e.g. malignancy)
    • Use of any antidepressants including SSRI, lithium or anti-convulsants for mood disorder in adequate dosage, with sufficiently long duration of antidepressive treatment and clinical outcome
    • Currently undergoing any form of psychotherapy
    • Absence of response to a previous adequate trial of escitalopram treatment
    • Life time history of early termination (<8 weeks) of escitalopram treatment because of adverse events or side effects
    • Life time history of early termination (< 8 weeks) of other SSRI (e.g. sertraline, citalo-pram) treatment because of adverse events or side effects
    • SCID documented bipolar affective disorder
    • Major DEP with psychotic features
    • Evidence of substance abuse or dependency during the previous 12 months
    • Moderate and severe dementia (MMSE < 18)
    • Serious risk of imminent suicide based on clinical judgment
    • Participation in another clinical trial
    • Inability to comply with PHQ-9 and/or SCID testing and/or telephone monitoring for mental or linguistic reasons or lack of access to telephone
    • Pregnancy or nursing period
    • Women with child bearing potential without effective contraception during the conduct of the trial
    • Expected low compliance with the visit schedule or telephone monitoring (e.g., due to comorbidity or travel distance to the trial site)
    • Patients with normal ventricular activation (no bundle branch block (total or incomplete), no other intraventricular conduction delay and no pacemaker) and known QTc* prolongation
    ≥ 500 ms OR inborn long QT syndrome
    • Patients with current treatment with drugs inducing QT prolongation, such as antiarrhythmic drugs class IA and III, anti-psychotics, tricyclic antidepressants
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time from randomization until death or hospitalization for any reason, whatever occurs first.
    As an exception, elective hospitalization for clearly non-cardiac reason is considered to be censoring, not an event. In contrast to this, emergency hospitalization for seemingly non-cardiac reason is considered an event because circumstances causing the emergency situation might be related to some cardiac condition. As well, elective hospitalization for seemingly non-cardiac reason which, however, might be related to cardiac condition, is considered to be an event.
    In order to avoid bias when using this endpoint, the blinded independent Endpoint Committee (members: see Appendix to Clinical Study Protocol) will classify each hospitalization to be or not to be an event.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months (minimum) up to 24 months
    E.5.2Secondary end point(s)
    Major secondary: Reduction of degree of depression as assessed by PHQ-9 / MADRS
    • Degree of depression as assessed by the Patient Health Questionnaire (PHQ-9) Scale and the Montgomery Asberg Depression Scale (MADRS)
    Further secondary:
    • Days alive out of hospital
    • PHQ-GAD-7 (General Anxiety Disorder) Scale
    • MMSE (mini mental state examination), assessment of cogni-tive dysfunction
    • Quality of life as assessed by the Short Form Health Survey-36 (SF-36), and the Kansas City Cardiomyopathy Question-naire (KCCQ)
    • Cardiovascular mortality
    • Cardiovascular morbidity
    • Health economy
    • Adherence to HF and study medication
    • CHF severity
    • Parameters of inflammation
    • Sympathetic nervous system function
    • Escitalopram plasma levels
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months (minimum) up to 24 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 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 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) 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 concerned11
    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 Yes
    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
    The end of the study is defined as the date of the last study visit of the last patient participating in the trial.
    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 months0
    E.8.9.1In the Member State concerned 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: 274
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state414
    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)
    For a period of four weeks after the last intake of study drugs, all AEs and SAEs need to be documented. In addition, a final telephone call of the study nurse will be placed to ensure the patient well-being and provide guidance should need arise.
    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 Decision2008-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-02
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