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    Summary
    EudraCT Number:2004-000320-32
    Sponsor's Protocol Code Number:10796
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-12-07
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2004-000320-32
    A.3Full title of the trial
    A double-blind, randomised, multicenter, fixed-dose study comparing the efficacy of escitalopram (20mg/day) with that of citalopram (40mg/day) in patients with Major Depressive Disorder
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number10796
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Cipralex
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    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.3.2Product code Lu 26-054
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNEscitalopram
    D.3.9.2Current sponsor codeLu 26-054
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10, 20
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Seropram
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    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 nameCipramil
    D.3.2Product code Lu 10-171
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNCitalopram
    D.3.9.2Current sponsor codeLu 10-171
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20, 40
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    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.1.3Condition 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 escitalopram (20mg/day) with that of citalopram (40mg/day) at the end of 8 weeks treatment of outpatients with Major Depressive Disorder (MDD)
    E.2.2Secondary objectives of the trial
    1) To compare the efficacy of escitalopram (20mg/day) and citalopram (40mg/day) during the course of the trial
    2) To evaluate the tolerability of escitalopram (20mg/day) and citalopram (40mg/day) during the course of the trial
    3) To evaluate the proportion of patients on escitalopram or citalopram who are in remission at Week 8. Remission is defined as a MADRS score less than or equal to 12
    4)To evaluate the proportion of patients who respond to escitalopram or citalopram treatment at Week 8 and their time to response. Response is defined as 50% decrease in MADRS total score from baseline
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. The patient is able to read and understand the Patient Information Sheet.
    2. The patient has signed the Informed Consent Form.
    3. The patient suffers from Major Depressive Disorder (current episode assessed with the MINI), diagnosed according to DSM-IV-TR criteria except with a prior duration of the current episode of at least 3 months and less than 2 years.
    4. The patient has a CGI-S score ≥5
    5. The patient has a MADRS total score at baseline ≥30.
    6. The patient has a SDS score ≥5 on at least one item.
    7. The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history, and vital signs.
    8. The patient is an outpatient.
    9. The patient is man or woman between 18 and 65 years of age, extremes inclusive.
    10. Patient is willing and able to attend study appointments within the allowable time windows.
    E.4Principal exclusion criteria
    1. The patient has previously participated in this study.
    2. The patient has made a suicide attempt in the past and has, in the investigator’s opinion, a significant risk of suicide and/or has a score greater than or equal to 5 on item 10 (suicidality) of the MADRS.
    3. The patient uses disallowed recent or concomitant medication:
    a. oral antipsychotics and antimanic drugs (including lithium) within 2 weeks and depot preparations within 6 months prior to baseline.
    b.electroconvulsive treatment (ECT) within the last 6 months prior to baseline.
    c.monoamine oxidase inhibitors (MAOIs) and reversible monoamine oxidase A inhibitors (RIMAs) within the last 3 weeks prior to baseline.
    d.fluoxetine within the last 4 weeks prior to baseline.
    e.any other antidepressant (including SNRIs) within the last week prior to baseline.
    f.herbal remedies, which are psychoactive (for example, St. Johns Wort, kava kava, valerian, ginkgo biloba etc.) within the last 2 weeks prior to baseline.
    g.any drug used for augmentation of antidepressant action within the last 2 weeks prior to baseline with the exception of stable treatment of hyper thyroidism.
    h.psychotropic drugs within the last week prior to baseline, except zolpidem, zopiclone, and zaleplon, which can be prescribed episodically for insomnia (maximum 3 days in a row, and maximum 6 days in total during the study).
    i.tryptophan within the last 2 weeks prior to baseline.
    j.dopamine antagonists (for example, metoclopramide), for any indication, within the last 2 weeks prior to baseline.
    k.any anxiolytics (including benzodiazepines) within the last week prior to baseline.
    l.any anticonvulsant drug (for example, phenytoin, carbamazepine etc) within the last 2 weeks prior to baseline.
    m.serotonergic agonists (for example, triptans) within the last 2 weeks prior to baseline.
    n.narcotic analgesics (except intermittent use of codeine-based analgesics for headache etc.) within 2 weeks prior to baseline.
    4. The patient has been treated with any investigational product within 3 months prior to baseline.
    5. The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram or citalopram.
    6. The patient is currently receiving formal behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the trial.
    7. The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 well-conducted, antidepressant treatments of at least 6 weeks duration.
    8. The patient has been treated with escitalopram or citalopram within the current major depressive episode.
    9. The patient has not responded to a previous treatment with escitalopram or citalopram.
    10. The patient has one or more of the following conditions:
    a. any current psychiatric disorder established as the principal diagnosis other than MDD as defined in the DSM-IV-TR.
    b. current or past history of obsessive compulsive disorder, 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.
    c. any substance abuse disorder (except nicotine and caffeine) as defined in the DSM-IV-TR with the exception of this being within the previous 6 months.
    d. presence or history of a clinically significant neurological disorder (including epilepsy).
    e. neurodegenerative disorder (Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, Huntington’s disease, etc.)
    f. any personality disorder that might compromise the study.
    11. The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance. If there is a history of such disease and this condition has been stable for at least one year, is not serious, is judged by the investigator not to render inclusion unsafe, and not to interfere with the patient’s participation or conduct in the study, the patient may be included.
    12. 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.
    13. The patient is pregnant or breast-feeding.
    14. The patient, if a woman of childbearing potential, is not using adequate contraception (defined as oral/systemic contraception, surgical sterilisation, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide).
    15. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy parameter will be MADRS total score.
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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 No
    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 No
    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
    The end of the study is defined as the date the database is locked based on the clean file.
    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 months6
    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 months6
    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 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 2004-12-07. 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    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 Decision2004-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-10-12
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