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    Summary
    EudraCT Number:2005-004006-81
    Sponsor's Protocol Code Number:LTE5376
    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:2006-02-22
    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 number2005-004006-81
    A.3Full title of the trial
    A double-blind, 6 to 12-month, multicenter, multinational, randomized study evaluating the efficacy and safety of SR58611A (350 mg q12) versus placebo in the prevention of relapse / recurrence of depressive symptoms in patients with major depressive disorder improved after 8 months of open treatment with SR58611A (350 mg q12)
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberLTE5376
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 Sponsorsanofi-aventis recherche&developpement
    B.1.3.4CountryFrance
    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 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 Information not present in EudraCT
    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 nameNA
    D.3.2Product code SR58611A
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.1CAS number 121524-09-2
    D.3.9.2Current sponsor codeSR58611A
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    patients with major depressive disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10018105
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of SR58611A 350 mg q12 compared to placebo in the prevention of relapse / recurrence of depressive symptoms, in sustained responder patients with major depressive disorder, over 6 to 12-month treatment period.
    E.2.2Secondary objectives of the trial
    To evaluate the tolerability and the safety of SR58611A in patients with major depressive disorders.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Out-patients 18 years old or more.
    2. Patients suffering from Major Depressive Disorder, and presenting a Major Depressive Episode according to DSM-IV-TR criteria Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) and assessed with the Mini International
    Neuropsychiatric Interview (MINI).
    3. Recurrent episode, with either 2 or more previous episodes, or only one previous
    episode but within the last 5 years.
    4. The duration of the current episode is at least of 2 months.
    5. With a total score on the Montgomery and Asberg Depression Rating Scale
    (MADRS) ≥ 28.
    6. Patients have given voluntarily their written informed consent to participate in the
    whole maintenance study.
    7. Able to comply with the protocol and follow written and verbal instructions.

    At Week 8, patients will be qualified for pursuing the study if:
    • MADRS < 12 (remission criterion).
    At Week 34, improved patients will be randomized into the double-blind phase if they have:
    • a MADRS total score < 16 at W12, W18, W24 and W30,
    • and a MADRS score < 12 at W34.
    E.4Principal exclusion criteria
    1. Patients at immediate risk for suicidal behavior based on an unstructured clinical
    interview; or who have, before first study drug intake [at either the screening (V1) or
    baseline (V2) visits]:
    - A score of >5 on the suicidal thoughts item of the MADRS
    - Or, a current suicide risk score ≥10 or “high risk” on module C of the (MINI).
    2. Patients with a major depressive episode with psychotic features, catatonic features, seasonal pattern or postpartum onset according to MINI at screening.
    3. Patients with 3 or more episodes of depression in the last 3 years.
    4. The course of the current depressive episode is longer than 2 years.
    5. For the current episode, patients failed to respond to an adequate dose of an
    antidepressant given for 6 weeks.
    6. Patients with mood disorder due to general medical conditions (degenerative
    neurological conditions, cerebrovascular disease, endocrine conditions, viral or other
    infections).
    7. Patients with a lifetime history according to MINI at screening of:
    − bipolar disorder or psychotic disorder,
    − antisocial personality disorder.
    8. Patients with a current history according to MINI at screening of:
    − alcohol dependence or abuse or substance dependence or abuse in the past
    12 months, except nicotine or caffeine dependence,
    − eating disorders.
    9. Introduction of, or change in intensity of psychotherapy from 3 months prior to
    screening.
    10. Treatment with a MAO Inhibitor (during one week or more) within 2 weeks prior to screening.
    11. Treatment with fluoxetine (during one week or more) within 4 weeks prior to
    screening.
    12. Chronic use of hypnotics / benzodiazepines. Chronic means more than 2 days per
    week during the previous month.
    13. Patients who have received Electro-Convulsive Therapy (ECT) for the previous Major Depressive Episode.
    14. Patients who received any antipsychotic drugs in the last 4 weeks prior to screening.
    15. Patients with severe or unstable concomitant medical conditions (cardiovascular,
    neurologic, gastrointestinal, hepatic, renal, endocrinologic, rheumatologic) according
    to the investigator's judgment that would impact the assessment of the study drug.
    16. History of seizures other than a single childhood febrile seizure.
    17. Patients with abnormal thyroid functioning, i.e. TSH blood level at screening out of normal range, unless patients are taking a hormone replacement therapy at a stable dose for at least 3 months prior to baseline.
    18. Patients with clinically significant abnormal laboratory value at screening, e.g. ALT or AST > 2 times upper limit of normal range (ULN), hemoglobin < 12g / 100ml for
    male and < 11g / 100ml for female, neutrophils < 1500/mm3, platelets < 100 000/mm3, creatinine ≥ 150 µmol/l.
    19. Patients with clinically significant ECG findings at screening.
    20. Patients with positive results on the urine drug screen at screening.
    21. Patients who have taken an investigational drug in the last 3 months prior to screening.
    22. Any subject who has previously participated in a SR58611A protocol.
    23. Women who are pregnant or breast-feeding; women of childbearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse: for example intrauterine device, oral contraceptives, implant, hormonal injection, barrier devices or barrier devices with spermicide.
    E.5 End points
    E.5.1Primary end point(s)
    Time to relapse / recurrence of depressive disorder, defined as any of the following :
    - MADRS ≥ 17 confirmed at a subsequent visit
    planned 2 weeks later unless the patient drops out,
    - Any drop-out for lack of efficacy (according to
    investigator’s decision based on his/her knowledge of
    the patient),
    - Any suicide attempt / suicide.
    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 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 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) 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) 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.8.5The 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
    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 years2
    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 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) Information not present in EudraCT
    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 2006-02-22. 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 800
    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 Decision2006-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-01
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