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    Summary
    EudraCT Number:2021-004404-18
    Sponsor's Protocol Code Number:ARIANNA
    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:2021-10-20
    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 number2021-004404-18
    A.3Full title of the trial
    The impact of aripiprazole long-acting on myelin and cognition in the onset of schizophrenia
    Impatto della terapia con aripiprazolo long-acting sulle anomalie strutturali e mieliniche e sui deficit cognitivi in pazienti con esordio di schizofrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of antipsychotic therapy with aripiprazole long-acting on the brain structure of patients with a first episode of schizophrenia
    Impatto della terapia antipsicotica con aripiprazolo in formulazione a rilascio prolungato sulla struttura cerebrale dei pazienti al primo episodio di schizofrenia
    A.3.2Name or abbreviated title of the trial where available
    ARIANNA
    ARIANNA
    A.4.1Sponsor's protocol code numberARIANNA
    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 SponsorFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOtsuka Pharmaceutical Italy s.r.l., Via Fabio Filzi 29, 20124 - Milano (MI)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    B.5.2Functional name of contact pointUOC Psichiatria
    B.5.3 Address:
    B.5.3.1Street AddressVia Francesco Sforza, 35
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number0255035982
    B.5.5Fax number0255035952
    B.5.6E-mailpaolo.brambilla@policlinico.mi.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 ABILIFY MAINTENA - 300 MG - POLVERE E SOLVENTE PER SOSPENSIONE A RILASCIO PROLUNGATO PER INIEZIONE - USO INTRAMUSCOLARE - FLACONCINO (VETRO) - POLVERE: 300 MG + SOLVENTE: 2 ML - 1 FLACONCINO POLVERE + 1 FLACONCINO SOLVENTE + 1 SIRINGA CON AGO + 1 SIR
    D.2.1.1.2Name of the Marketing Authorisation holderOTSUKA PHARMACEUTICAL EUROPE LTD
    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 nameAbilify Maintena
    D.3.2Product code [Aripiprazolo long-acting]
    D.3.4Pharmaceutical form Powder and solvent for prolonged-release suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNARIPIPRAZOLO
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeAripiprazolo long acting
    D.3.9.3Other descriptive nameLong acting aripiprazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    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 ABILIFY MAINTENA - 400 MG - POLVERE E SOLVENTE PER SOSPENSIONE A RILASCIO PROLUNGATO PER INIEZIONE - USO INTRAMUSCOLARE - FLACONCINO (VETRO) - POLVERE: 400 MG + SOLVENTE: 2 ML - 1 FLACONCINO POLVERE + 1 FLACONCINO SOLVENTE + 1 SIRINGA CON AGO + 1 SIR
    D.2.1.1.2Name of the Marketing Authorisation holderOTSUKA PHARMACEUTICAL EUROPE LTD
    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 nameAbilify Maintena
    D.3.2Product code [Aripiprazolo long-acting]
    D.3.4Pharmaceutical form Powder and solvent for prolonged-release suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNARIPIPRAZOLO
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeAripiprazolo long-acting
    D.3.9.3Other descriptive nameLong acting Aripiprazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Yes
    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
    Onset of schizophrenia
    Esordio di schizofrenia
    E.1.1.1Medical condition in easily understood language
    Onset of symptoms of schizophrenia
    Prima presentazione di sintomatologia schizofrenica
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    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
    The overall objective is to explore the impact of long acting aripiprazole on brain structure, in particular the potential neurotrophic, neurogenetic and neuroprotective effects that could counteract the progressive neuronal degeneration inherent in psychotic pathology itself. In other words, the primary objective is to assess whether the achievement of therapeutic control of the pathology by this antipsychotic drug corresponds to a change in brain structure, in terms of connectivity.
    L’obiettivo generale dello studio è quello di esplorare l’impatto dell’aripiprazolo long-acting sulla struttura cerebrale, in particolare i potenziali effetti neurotrofici, neurogenetici e neuroprotettivi che potrebbero contrastare la degenerazione progressiva insita nella patologia psicotica stessa.
    In particolare, l’obiettivo primario è quello di valutare se al raggiungimento del controllo terapeutico della patologia mediante tale farmaco antipsicotico corrisponda una modifica della struttura cerebrale in termini di connettività.
    E.2.2Secondary objectives of the trial
    - Evaluate the impact of long-acting aripiprazole on clinical outcome (in terms of number of relapses and symptomatology), global functioning and cognitive performances in patients at first episode of psychosis
    - evaluate the safety profile of the drug
    - investigate the change in brain structure, in terms of morphology associated to the use of long-acting aripiprazole
    - Valutare l’effetto dell’aripiprazolo long acting sull’outcome clinico (in termini di ricadute e sintomatologia clinica), sul funzionamento globale e sulle performance cognitive dei pazienti affetti da schizofrenia.
    - Valutare il profilo di tollerabilità del farmaco
    - Indagare le eventuali modificazioni morfologiche cerebrali associate all’utilizzo di aripiprazolo long-acting.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with onset of schizophrenia, diagnosed using a structured clinical interview (SCID- 5 CV) by medical doctors.
    - Patients between 18 and 65 years of age, who, after a stabilization period with aripiprazole in oral formulation, have to start aripiprazole long-acting therapy for clinical reasons (i.e. regardless of study participation) or who have been on therapy for no more than two weeks.
    - No other psychotropic treatments in the two weeks before entering the study
    - Ability to provide informed consent
    - Fertile women can only be included after a negative highly sensitive urine or serum pregnancy test (betaHCG). Women must use a highly effective birth control method for the entire duration of the study.
    - Esordio di schizofrenia diagnosticato mediante il supporto di intervista clinica strutturata (SCID-5 CV) da parte di personale medico specializzato.
    - età compresa tra i 18 e i 65 anni compiuti, che, dopo un periodo di stabilizzazione con aripiprazolo in formulazione orale, devono iniziare una terapia con aripiprazolo long-acting per esigenze cliniche (e quindi indipendentemente dalla partecipazione allo studio) o già in terapia con aripiprazolo long-acting da non più di due settimane.
    - assenza di altri farmaci psicotropi per almeno due settimane precedenti all’inizio dello studio.
    - che hanno firmato il consenso informato alla partecipazione allo studio
    - per le donne in età fertile è richiesta l’esecuzione di un test di gravidanza (ricerca betaHCG su urine o sangue) subito prima dell’inizio della terapia e l'assunzione per l’intera durata dello studio di un metodo contraccettivo altamente efficace
    E.4Principal exclusion criteria
    - Comorbidity with other psychiatric disorders (on the basis of SCID 5- CV) or neurologic disorders;
    - Previous antipsychotic treatments. However, patients previously stabilised with other antipsychotic drugs will be admitted, provided that they have not been treated for more than one month and in the two weeks prior to enrolment. Only administration of aripiprazole in oral formulation, necessary for the insertion of long acting aripiprazole, is allowed.
    - Contraindications to taking long-acting aripiprazole as described in SmPC;
    - Medical history of intellectual disability;
    - Alcohol or substances abuse in the last 6 months;
    - Presence of absolute or relative contraindications to the performance of MRI;
    - Pregnant women (if pregnancy occurs during the study, the patient will be excluded
    from continuing the study) or women of childbearing age who have not carried out a negative pregnancy test before taking the drug and who are not using a highly effective method of contraception.
    - presenza di codiagnosi con altre patologie psichiatriche (sulla base della SCID-5 CV) o neurologiche;
    - pregresse terapie antipsicotiche. Saranno comunque ammessi pazienti precedentemente stabilizzati con altri farmaci antipsicotici, purché assunti per un periodo di tempo non superiore a un mese e purché non siano stati assunti nelle 2 settimane antecedenti all’arruolamento, fatta eccezione per l’aripiprazolo in formulazione orale, la cui assunzione è necessaria ai fini dell’inserimento dell’aripiprazolo in formulazione long-acting.
    - controindicazioni all’assunzione di aripiprazolo long-acting come da RCP;
    - presenza in anamnesi di disabilità intellettiva;
    - abuso di alcool o sostanze nei 6 mesi precedenti;
    - presenza di controindicazioni assolute o relative all’esecuzione di RM;
    - donne in stato di gravidanza (se la gravidanza sopraggiungesse durante lo studio la paziente verrà esclusa dalla prosecuzione dello studio) o donne che non abbiano eseguito un test di gravidanza risultato negativo prima dell’inizio della terapia e che non adottino validi metodi contraccettivi.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in Myelination of specific white tracts (Myelin Water Fraction- MWF) after 3 months of antipsychotic treatment with long-acting aripiprazole compared to the basal.
    Valutazione della modificazione della mielinizzazione dei fasci di sostanza bianca (in termini di Myelin Water Fraction - MWF) dopo 3 mesi di terapia antipsicotica con aripiprazolo long-acting rispetto al basale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three months
    Tre mesi
    E.5.2Secondary end point(s)
    - Evaluation of the efficacy of aripiprazole on clinical outcome, measured by changes in the score of the psychopathological scales (PANSS and BPRS), and on cognitive performance, measured in terms of changes in the scores of the neuropsychological scales (BAC-S), at 3 months compared to baseline;
    - Number of serious and non-serious AEs related to the treatment with long-acting aripiprazole. Adverse events will be assessed on the basis of the patient's clinical observation, laboratory tests (e.g. biochemical, haematological, urine tests) or other clinical tests (e.g. ECG, radiological tests, vital signs)
    - Brain structure modifications (gray matter volumes, cortical area and thickness) after 3-month treatment with long-acting aripiprazole compared to the basal;
    ¿ Valutazione dell’efficacia di aripiprazolo long-acting sull’outcome clinico, misurato tramite variazione dello score delle scale psicopatologiche (PANSS e BPRS), e sulle performance cognitive, misurate in termini di variazioni di punteggi delle scale neuropsicologiche (BAC-S), a 3 mesi rispetto al basale.
    ¿ Valutazione del profilo di tollerabilità sulla base del numero di EA seri e non seri giudicati dallo staff medico come correlati al farmaco oggetto di studio. Gli eventi avversi saranno valutati sulla base dell’osservazione clinica del paziente, di esami di laboratorio (ad es. biochimici, ematologici, test delle urine) o di altri esami clinici (ad es. ECG, esami radiologici, segni vitali).
    ¿ Valutazione della modificazione della struttura cerebrale in termini di volumi di materia grigia, area corticale superficiale e spessore corticale dopo 3 mesi di terapia antipsicotica con aripiprazolo long-acting rispetto al basale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Three months
    Tre mesi
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 15
    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)
    After study participation, patients will continue clinical assessments and treatment as per normal clinical practice.
    Al termine della partecipazione allo studio i pazienti proseguiranno le visite di controllo ed il trattamento secondo la normale pratica clinica.
    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 Decision2021-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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