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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-020726-18
    Sponsor's Protocol Code Number:H9P-MC-LNBO
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-15
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-020726-18
    A.3Full title of the trial
    Estudio Abierto de Seguridad a Largo Plazo de LY2216684 12 a 18 mg Una Vez al Día como Tratamiento Adyuvante para Pacientes con Trastorno Depresivo Mayor con Respuesta Parcial al Tratamiento con un Inhibidor Selectivo de la Recaptación de Serotonina
    Long-Term, Open-Label, Safety Study of LY2216684 12 to 18 mg Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder Who are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment
    A.3.2Name or abbreviated title of the trial where available
    LNBO
    A.4.1Sponsor's protocol code numberH9P-MC-LNBO
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 nameLY2216684
    D.3.2Product code LY2216684
    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 INNLY2216684
    D.3.9.3Other descriptive nameLY2216684
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12 to 18
    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 Yes
    D.3.11.13.1Other medicinal product typeInhibidor de la recaptación de la Norepinefrina. Norepinephrine reuptake inhibitor (NERI)
    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
    Transtorno depresivo mayor (TDM)
    Major depressive disorder (MDD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo primario de este estudio es evaluar la seguridad y tolerabilidad a largo plazo de LY2216684 administrado una vez al día (QD) en el tratamiento adyuvante con un inhibidor selectivo de la recaptación de serotonina (ISRS) por hasta 1 año aproximadamente en pacientes con trastorno depresivo mayor (TDM) con respuesta parcial a su tratamiento con un ISRS. Las medidas de seguridad incluyen la recopilación y reporte de las tasas de discontinuación, eventos adversos emergentes del tratamiento (EAETs), signos vitales, peso, electrocardiogramas (ECGs) y análisis de laboratorio.
    The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in patients with major depressive disorder (MDD) who are partial responders to their SSRI treatment. The safety measures include the collection and reporting of disco
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad y tolerabilidad de LY2216684 como tratamiento adyuvante para pacientes con TDM con respuesta parcial a su tratamiento con un ISRS medidas con los siguientes indicadores:EASs, EAEDs, C-SSRS, ASEX. CPFQ -Evaluar el efecto de LY2216684 en los síntomas depresivos como tratamiento adyuvante para pacientes con TDM con respuesta parcial a su tratamiento con un ISRS medido por el cambio respecto de la línea basal usando los siguientes indicadores:MADRS, HADS, CGI-S, FAsD, SDS, Q-LES-Q-SF -Evaluar el efecto de LY2216684 como tratamiento adyuvante para pacientes con TDM con respuesta parcial a su tratamiento con un ISRS para reducir los síntomas de fatiga asociados con la depresión, medido por el cambio respecto de la línea basal usando el siguiente indicador:Calificación promedio de Fatiga Asociada con la Depresión (FAsD), calificación de la subescala de la experiencia de fatiga y calificación de la subescala del impacto de la fatiga. - Evaluar el efecto de LY2216684 en l
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes externos adultos, hombres y mujeres de &#8805;18 años de edad que cumplen los criterios diagnósticos de DSM-IV-TR para TDM determinada por una evaluación clínica con la Mini Entrevista Neuropsiquiátrica Internacional (MINI) y confirmada por el médico y que han experimentado una respuesta parcial al tratamiento con un curso de tratamiento con un ISRS durante 6 semanas cuando menos, con al menos las 4 últimas semanas consecutivas con una dosis estable, optimizada antes de la Visita 2. Los pacientes deben tener una calificación &#8805;16 en la calificación total de la Escala de Calificación de Depresión de Hamilton GRID de 17 Ítems (GRID-HAMD17) en la Visita 1 y la Visita 2. Se determinará que los pacientes tienen una respuesta parcial por su historial, por la opinión del investigador. También se requerirá que los pacientes tengan una calificación que indique una mejora &#8804;75% en su tratamiento actual con un ISRS usando el Cuestionario de Respuesta al Tratamiento Antidepresivo del Hospital General de Massachusetts (MGH-ATRQ) en la Visita 1.
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] Meet criteria for MDD, as defined by DSM-IV-TR criteria without psychotic features, as determined by clinical assessment by the MINI and confirmed by the physician at Visit 1.
    [2] Are adult men or women at least 18 years of age or older at informed consent, who provide informed consent by signing the appropriate ICFs. Patients must be competent and able to give their own informed consent.
    [3] Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) may participate in the study. Women must test negative for pregnancy at the time of study entry based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of investigational product. Men participating agree to use a reliable method of birth control during the study.
    [4] Are being treated with one of the following SSRIs that have been approved for MDD treatment within the participating country: escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; and have been treated with their SSRI at least 6 weeks prior to Visit 2 with at least the last 4 consecutive weeks at a stable, optimized dose. The prescribed SSRI and its dose should be in accordance with labeling guidelines within the participating country.
    [5] Meet criteria for partial response at Visit 1 and Visit 2, as deemed by investigator?s opinion that the patient has experienced a minimal clinically meaningful improvement with SSRI.
    [6] Have a GRID HAMD17 total score ?16 at Visit 1 and Visit 2.
    [7] Have ?75% improvement on the current SSRI at Visit 1 determined by the MGH ATRQ.
    [8] Have an education level and a degree of understanding such that the patient can communicate with the site-study personnel.
    [9] Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations required by the protocol.
    E.4Principal exclusion criteria
    Los criterios de exclusión incluyen cualquier condición adicional en el Eje I del DSM-IV-TR distinta a la depresión mayor que fue considerada el diagnóstico primario dentro de 1 año desde la Visita 1; otro diagnóstico de ansiedad primaria en el Eje I dentro del último año (incluyendo trastorno de pánico, trastorno obsesivo-compulsivo [TOC], trastorno de estrés postraumático [TEPT], trastorno de ansiedad generalizada [TAG], y fobia social, pero excluyendo fobias específicas); diagnóstico actual o anterior de trastorno bipolar, esquizofrenia u otro trastorno psicótico; tener una condición medica seria o inestable; tener cualquier condición médica diagnosticada que pudiera ser exacerbada por agentes noradrenérgicos, incluyendo hipertensión inestable, enfermedad cardiaca inestable, taquicardia o taquiarritmia, glaucoma de ángulo estrecho, o historial de titubeo o retención urinaria; uso de medicamentos concomitantes excluidos; ideas serias/riesgo de autolesión o de lesionar a otros; y embarazo o lactancia.
    Patients 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 study involving an investigational drug or device or off-label use of a drug or device (other than the investigational product 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] Have previously completed or withdrawn from this study or any other study investigating LY2216684.
    [14] Have had or currently have any additional ongoing DSM-IV-TR Axis I condition other than MDD that was considered the primary diagnosis within 1 year of Visit 1.
    [15] Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder [OCD], posttraumatic stress disorder [PTSD], generalized anxiety disorder [GAD], and social phobia, but excluding specific phobias).
    [16] Have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder.
    [17] Have a history of substance abuse within the past 1 year (drug categories defined by DSM-IV-TR), and/or substance dependence within the past 1 year, not including caffeine and nicotine.
    [18] Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol.
    [19] Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the patient has treatment-resistant depression.
    [20] Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or psychosurgery within the last year.
    [21] Women who are pregnant or breastfeeding.
    [22] Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others.
    [23] Have a serious or unstable medical illness, including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic disease, renal disease, or clinically significant laboratory or ECG abnormality. Clinically significant lab or ECG abnormalities are those which, in the judgment of the investigator, indicate a serious medical problem or require significant intervention.
    [24] Have any diagnosed medical condition which could be exacerbated by noradrenergic agents, including unstable hypertension or unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or history of urinary hesitancy or retention.
    [25] Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.
    [26] Have a history of any seizure disorder (other than febrile seizures).
    [27] Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1 or have a potential need to use an MAOI within 3 days after discontinuation from the study.
    [28] Require psychotropic medication other than sedative/hypnotic medication for sleep as specified in the protocol or other than the current SSRI
    [29] Are taking or have received treatment with any excluded medications within 7 days prior to Visit 2.
    [30] Have a TSH level outside the laboratory established reference range. Patients previously diagnosed with hyperthyroidism or hypothyroidism who have been treated with a stable dose of thyroid supplement for at least the past 3 months, and who are clinically and chemically euthyroid, will be allowed to participate in the study.
    [31] Have initiated or discontinued hormone therapy within the previous 3 months prior to enr
    E.5 End points
    E.5.1Primary end point(s)
    El punto final para el Período II del Estudio se define como la última observación no faltante obtenida después de la Visita 2 hasta la Visita 12.
    The endpoint for Study Period II is defined as the last nonmissing observation obtained after Visit 2 through Visit 12.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 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) Yes
    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 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 2010-11-15. Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 600
    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 Decision2011-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
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