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    Summary
    EudraCT Number:2018-001622-26
    Sponsor's Protocol Code Number:QQ05.16.02
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-27
    Trial 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 number2018-001622-26
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter clinical trial to assess safety and effectiveness of Liposom in enhance and speed up response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD)
    Studio clinico multicentrico, randomizzato, in doppio-cieco, controllato verso placebo, per valutare la sicurezza e l'efficacia di Liposom nel potenziare e accelerare la risposta alla terapia antidepressiva con citalopram in pazienti anziani affetti da Disturbo Depressivo Maggiore (DDM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to assess safety and effectiveness of Liposom in enhance and speed up response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD)
    Studio clinico multicentrico, randomizzato, in doppio-cieco, controllato verso placebo, per valutare la sicurezza e l’efficacia di Liposom nel potenziare e accelerare la risposta alla terapia antidepressiva con citalopram in pazienti anziani affetti da Disturbo Depressivo Maggiore (DDM)
    A.3.2Name or abbreviated title of the trial where available
    Protocol Liposom
    Protocollo Liposom
    A.4.1Sponsor's protocol code numberQQ05.16.02
    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 SponsorFIDIA FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    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 supportFidia Farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLB Research s.r.l.
    B.5.2Functional name of contact pointScientific Direction
    B.5.3 Address:
    B.5.3.1Street AddressVia Lombardia 81
    B.5.3.2Town/ cityCantù
    B.5.3.3Post code22063
    B.5.3.4CountryItaly
    B.5.4Telephone number031734908
    B.5.5Fax number0317372218
    B.5.6E-mailflavia.baruzzi@lbresearch.it
    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 LIPOSOM FORTE - 28 MG/2 ML SOLUZIONE INIETTABILE
    D.2.1.1.2Name of the Marketing Authorisation holderFIDIA FARMACEUTICI S.P.A.
    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 nameLiposom Forte
    D.3.2Product code [QQ05]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeFosfolipidi ipotalamici
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 CITALOPRAM AUROBINDO - 20 MG COMPRESSE RIVESTITE CON FILM 28 COMPRESSE DIVISIBILI
    D.2.1.1.2Name of the Marketing Authorisation holderAUROBINDO PHARMA (ITALIA) S.R.L.
    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 nameCitalopram Aurobindo
    D.3.2Product code [Citalopram Aurobindo]
    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 INNCITALOPRAM BROMIDRATO
    D.3.9.2Current sponsor codeCitalopram Aurobindo
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder (MDD) in elderly patients
    Disturbo Depressivo Maggiore nell'anziano
    E.1.1.1Medical condition in easily understood language
    Depression in elderly patients
    Depressione Maggiore nell'anziano
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    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 determine if Liposom Forte will enhance the response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD).
    Determinare se Liposom Forte possa potenziare la risposta alla terapia antidepressiva con citalopram in pazienti anziani affetti da Disturbo Depressivo Maggiore (DDM)
    E.2.2Secondary objectives of the trial
    To determine if Liposom Forte will speed up response to antidepressant therapy with citalopram
    To determine the Clinical Global Impression to treatments
    To assess the safety of study treatments
    Determinare se Liposom Forte possa accelerare la risposta alla terapia antidepressiva con citalopram
    Determinare l’impressione clinica globale ai trattamenti
    Valutare la sicurezza dei trattamenti in studio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Meets DSM-V criteria for major depressive disorder
    2. Score of >= 16 in the HAM-D
    3. Score of >= 23 on the Mini-Mental State Exam (MMSE-2)
    4. Aged >= 65 years
    5. Patients able to understand the study procedures and to comply with protocol requirements
    6. Patients legally able to give written informed consent to the trial (signed and dated by the subject)
    1. Rispettare i criteri DSM-V per il Disturbo Depressivo Maggiore
    2. Un punteggio >= 16 alla scala HAM-D
    3. Un punteggio >= 23 al Mini-Mental State Exam (MMSE-2)
    4. Età >= 65 anni
    5. Pazienti in grado di comprendere le procedure di studio e di rispettare i requisiti del protocollo
    6. Pazienti legalmente in grado di fornire il loro consenso informato scritto allo studio (firmato e datato dal soggetto)
    E.4Principal exclusion criteria
    1. Any contraindication for treatment or intolerance to Liposom Forte or citalopram
    2. Congenital long QT syndrome, severe bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval.
    3. History of psychiatric disorder other than major depressive disorder, including history of substance use disorder
    4. Presence of psychotic symptoms, even if they are not sufficient to make diagnosis of a mental disorder
    5. Severe uncompensated and/or acute organic disease or any other medical condition which may interfere with the aim of the study or with the subject health and well-being
    6. Major neurocognitive disorders (also called dementia)
    7. Diabetes Mellitus type I and II
    8. Acute suicidal or violent behaviour or history of suicide attempt within the year prior to study entry or current suicidal ideation
    9. Treated with long acting injectable (LAI) antipsychotics within 6 months prior to study entry
    10. Treated with any antipsychotics, antidepressant, food supplements (St. John's Wort) or over-the-counter CNS-active medications within 2 weeks prior to the first administration of study medication, with the exception of MAOIs, for which the treatment is not permitted in the 3 weeks prior to the first administration of study medication
    11. Ongoing psychotherapy or other psychological treatment during the study period.
    1. Qualsiasi controindicazione al trattamento o intolleranza a Liposom Forte o citalopram
    2. Sindrome congenita del QT lungo, bradicardia severa, infarto miocardico acuto recente, insufficienza cardiaca non compensata o uso concomitante di farmaci che prolungano l’intervallo QT.
    3. Storia di disturbo psichiatrico tranne il disturbo depressivo maggiore, inclusa storia di disturbo da uso di sostanze
    4. Presenza di sintomi psicotici, anche se non sufficienti ad effettuare una diagnosi di disturbo mentale
    5. Malattia organica grave non compensata e/o acuta o qualsiasi altra condizione medica che possa interferire con la finalità dello studio o con la salute ed il benessere del soggetto
    6. Disturbi neurocognitivi maggiori (anche denominati demenza)
    7. Diabete Mellito di tipo 1 e 2
    8. Acuto comportamento suicidario o violento o storia di tentativo di suicidio nell’anno precedente l’ingresso nello studio oppure attuale ideazione suicidaria
    9. Trattamento con antipsicotici iniettabili a lunga durata d’azione entro i 6 mesi precedenti l’ingresso nello studio
    10. Trattamento con qualsiasi antipsicotico, antidepressivo, integratore alimentare (Erba di San Giovanni) o farmaco da banco attivo sul Sistema Nervoso Centrale nelle 2 settimane precedenti la prima somministrazione del farmaco in studio, ad eccezione degli inibitori delle monoamminoossidasi (MAOI), per i quali il trattamento non è consentito nelle 3 settimane precedenti la prima somministrazione del farmaco in studio
    11. Psicoterapia in corso oppure altro trattamento psicologico durante il periodo dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Il miglioramento dei sintomi depressivi verrà valutato alla Visita 5 (giorno 30), attraverso la variazione rispetto al basale della Hamilton Rating Scale for Depression (HAM-D a 21-item)
    Improvement of depressive symptoms will be evaluated at Visit 5 (day 30), as change from baseline, using the Hamilton Rating Scale for Depression (21-item HAM-D).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Visit 5 (day 30)
    Visita 5 (giorno 30)
    E.5.2Secondary end point(s)
    Improvement of depressive symptoms will be evaluated over the entire study as change from baseline using the HAM-D.; Percentage of patient’s responders at V2, V3, V4 and V5. A patient with a = 50% improvement in HAM-D score vs. baseline will be considered as a responder.; Reduction of latency time will be evaluated at V2, V3, V4 and V5 using the HAM-D. Latency time will be defined as the time from baseline to response (a = 50% improvement in HAM-D score vs. baseline).; Improvement of depressive symptoms will be evaluated as change from baseline using the Geriatric Depression Scale (GDS-15) at each visit, up to V8 (Day 90).; Clinical Global Impression will be evaluated as change from baseline using the CGI score at each visit, up to V8 (Day 90).; To assess the safety of study treatments by tracking the adverse events at each visit, up to V8 (Day 90), by ECG and vital signs measurements.
    Il miglioramento dei sintomi depressivi verrà valutato durante tutto lo studio, come variazione rispetto al basale della scala HAM-D.; Percentuale di pazienti responder a V2, V3, V4, V5. Un paziente con un miglioramento rispetto al basale del punteggio della scala HAM-D = 50%, verrà considerato responder.; La riduzione del tempo di latenza verrà valutata a V2, V3, V4, V5, mediante la scala HAM-D. Il tempo di latenza verrà definito come il tempo tra il basale e la risposta (un miglioramento = 50% del punteggio della scala HAM-D rispetto al basale); Il miglioramento dei sintomi depressivi verrà valutato ad ogni visita fino a V8 (giorno 90), come variazione rispetto al basale della scala della Depressione geriatrica (GDS-15, Geriatric Depression Scale); L’impressione clinica globale verrà valutata ad ogni visita fino a V8 (giorno 90), come variazione rispetto al basale del punteggio della scala CGI (Clinical Global Impression).; Valutare la sicurezza dei trattamenti in studio rilevando gli eventi avversi, effettuando un ECG e valutando i segni vitali ad ogni visita fino a V8 (Giorno 90).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At day 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) and 90 (V8); At day 7 (V2), 14 (V3), 21 (V4), 30 (V5); At day 7 (V2), 14 (V3), 21 (V4), 30 (V5); At day 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) and 90 (V8); At day 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) and 90 (V8); At day 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) and 90 (V8)
    Al giorno 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) e 90 (V8); Al giorno 7 (V2), 14 (V3), 21 (V4), 30 (V5); Al giorno 7 (V2), 14 (V3), 21 (V4), 30 (V5); Al giorno 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) e 90 (V8); Al giorno 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) e 90 (V8); Al giorno 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) e 90 (V8)
    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 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 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 concerned10
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months3
    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 months3
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    At the end of the 90 days of treatment the Principal Investigator together with the patient will decide if to continue or discontinue the treatment to citalopram out of the study
    Al termine dei 90 giorni di trattamento, lo Sperimentatore Principale, insieme con il paziente, deciderà se continuare o no il trattamento con citalopram al di fuori dello studio
    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 Decision2018-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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