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    Summary
    EudraCT Number:2019-001325-27
    Sponsor's Protocol Code Number:18314A
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-10-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001325-27
    A.3Full title of the trial
    Interventional, open-label effectiveness study of flexible doses of vortioxetine on depressive symptoms in patients with major depressive disorder comorbid with generalized anxiety disorder
    Studio interventistico, in aperto, sull'efficacia di dosi flessibili di vortioxetina su sintomi depressivi in pazienti con disturbo depressivo maggiore con comorbilità di disturbo d'ansia generalizzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)
    Vortioxetina in pazienti con depressione coesistente con disturbo d’ansia generalizzata (GAD)
    A.3.2Name or abbreviated title of the trial where available
    Reconnect
    Reconnect
    A.4.1Sponsor's protocol code number18314A
    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 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 supportH. Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH. Lundbeck A/S
    B.5.2Functional name of contact pointLundbeckClinicalTrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9
    B.5.3.2Town/ cityValby
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    B.5.4Telephone number004536301311
    B.5.5Fax number004536301940
    B.5.6E-mailLundbeckClinicalTrials@lundbeck.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 BRINTELLIX - 10 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderH. LUNDBECK A/S
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 name/
    D.3.2Product code [/]
    D.3.4Pharmaceutical form Film-coated 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 INNvortioxetina
    D.3.9.1CAS number 508233-74-7
    D.3.9.2Current sponsor code/
    D.3.9.4EV Substance CodeSUB88928
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 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.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 Yes
    D.2.1.1.1Trade name BRINTELLIX - 20 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderH. LUNDBECK A/S
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 name/
    D.3.2Product code [/]
    D.3.4Pharmaceutical form Film-coated 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 INNvortioxetina
    D.3.9.1CAS number 508233-74-7
    D.3.9.2Current sponsor code/
    D.3.9.4EV Substance CodeSUB88928
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 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 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
    Depressive symptoms in patients with major depressive disorder (MDD) comorbid with generalized anxiety disorder (GAD)
    Sintomi depressivi in pazienti con disturbo depressivo maggiore (MDD) in comorbidità con disturbo d'ansia generalizzata (GAD)
    E.1.1.1Medical condition in easily understood language
    Depression and anxiety
    Depressione e ansia
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    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
    To assess the effectiveness of 8-week acute treatment with 10–20 mg/day vortioxetine on depressive symptoms in patients with major depressive disorder (MDD) comorbid with generalized anxiety disorder (GAD).
    Valutare l'efficacia del trattamento acuto di 8 settimane con vortioxetina 10-20 mg/die su sintomi depressivi in pazienti con disturbo depressivo maggiore (MDD) con comorbilità di disturbo d'ansia generalizzata (GAD).
    E.2.2Secondary objectives of the trial
    To assess the effectiveness of vortioxetine on:
    • anxiety symptoms
    • functioning
    • global clinical impression
    • health-related quality of life
    Valutare l'efficacia di vortioxetina su:
    - Sintomi d'ansia,
    - funzionalità,
    - impressione clinica globale,
    - qualità della vita correlata alla salute.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient has a primary diagnosis of MDE, diagnosed according to DSM-5® confirmed using the Mini International Neuropsychiatric Interview (MINI)
    • The patient has had the current MDE for <12 months
    • The patient has current comorbid Generalized Anxiety Disorder (GAD) according to DSM-5®. The diagnosis was made prior to the current MDE
    • The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score = 22 at the Baseline Visit
    • The patient has a Hamilton Anxiety Rating Scale (HAM-A) score = 20 at the Baseline Visit
    • Il paziente ha una diagnosi primaria di MDE, diagnosticato dal DSM-5® e confermato mediante l’intervista Mini International Neuropsychiatric Interview (MINI)
    • Il paziente presenta l’attuale MDE da <12 mesi
    • Secondo il DSM-5® il paziente presenta una comorbidità con il disturbo d’ansia generalizzata (GAD). La diagnosi è stata effettuata prima del MDE in corso
    • Il paziente ha un punteggio totale al basale = 22 della Montgomery and Åsberg Depression Rating Scale (MADRS)
    • Il paziente ha un punteggio totale al basale = 20 della Hamilton Anxiety Rating Scale (HAM-A)
    E.4Principal exclusion criteria
    • The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview.
    • The patient has a history of previous major depressive episodes considered as treatment resistant, defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator’s opinion.
    • Alla diagnosi primaria, oltre a MDD, il paziente presenta una qualsiasi patologia psichiatrica corrente o disturbo di Asse I (criteri del DSM-5®), in base alla valutazione effettuata mediante l’intervista Mini International Neuropsychiatric Interview (MINI) o altra intervista diagnostica.
    • Il paziente ha un’anamnesi remota di episodi depressivi maggiori considerati resistenti al trattamento, condizione definita come risposta inadeguata (risposta terapeutica incompleta o assente) a due precedenti cicli di almeno 6 settimane di antidepressivi convenzionali a una dose adeguata, oppure a giudizio dello sperimentatore il paziente è affetto da depressione resistente al trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
    Variazione del punteggio totale della Montgomery and Åsberg Depression Rating Scale (MADRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 8
    Dal baseline alla settimana 8.
    E.5.2Secondary end point(s)
    • Change in Hamilton Anxiety Rating Scale (HAM-A) total score*
    • Change in Hospital Anxiety and Depression Scale (HADS) total score*
    • Change in Functioning Assessment Short Test (FAST) total score*
    • Change in Clinical Global Impression - Severity of Illness (CGI-S) score*
    • Clinical Global Impression Scale- Global Improvement (CGI-I) score**
    • Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score*
    • Variazione del punteggio totale della Hamilton Anxiety Rating Scale (HAM-A)*
    • Variazione del punteggio totale della Hospital Anxiety and Depression Scale (HADS)*
    • Variazione del punteggio totale della Functioning Assessment Short Test (FAST)*
    • Variazione del punteggio della scala Clinical Global Impression - Severity of Illness (CGI-S)*
    • Punteggio della scala Clinical Global Impression Scale- Global Improvement (CGI-I)*
    • Variazione del punteggio totale del questionario Quality of Life Enjoyment and Satisfaction Questionnaire (QLES-Q)*
    E.5.2.1Timepoint(s) of evaluation of this end point
    *) From baseline to Week 8
    **) At Week 8
    *) Dal baseline alla settimana 8
    **) Alla settimana 8
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA15
    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
    Estonia
    Finland
    France
    Italy
    Korea, Republic of
    Spain
    Switzerland
    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
    The overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study. The last protocol-specified contact is a safety follow-up. This may be a telephone contact, unless an SAE has occurred since the previous visit. The safety follow-up must be conducted 4 weeks after the last dose of IMP.
    La fine della sperimentazione è definita dall’ultimo contatto specificato da protocollo con l’ultimo paziente in studio. L’ultimo contatto specificato da protocollo è il follow-up di sicurezza. Questo si può svolgere telefonicamente, salvo qualora sia comparso un SAE dalla precedente visita. Il follow-up di sicurezza deve essere eseguito 4 settimane dopo l’ultima dose di IMP.
    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 months0
    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 months0
    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: 100
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 100
    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)
    None
    nessuno
    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 Decision2020-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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