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    Summary
    EudraCT Number:2011-003850-26
    Sponsor's Protocol Code Number:31-11-284
    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:2012-03-02
    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 number2011-003850-26
    A.3Full title of the trial
    A Multicenter, Open-label Study to Assess Hospitalization Rates in Adult Subjects with Schizophrenia Treated Prospectively for 6 Months with Aripiprazole IM Depot Compared with 6-month Retrospective Treatment with Oral Antipsychotics in a Naturalistic Community Setting in Europe, Canada, and Asi
    Studio multicentrico in aperto per valutare il tasso di ospedalizzazione di soggetti adulti con schizofrenia trattati in maniera prospettica per 6 mesi con aripiprazolo i.m. a lento rilascio in confronto al trattamento retrospettivo a 6 mesi con antipsicotici orali in comunita' nella pratica clinica reale in Europa, Canada e Asia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the number of hospitalizations of adults with schizophrenia treated with the study drug aripiprazole IM depot for 6 months, compared to those that have been treated with oral antipsychotics over the last 6 months in Europe, Canada and Asia
    Studio per valutare il numero di ricoveri di soggetti adulti affetti da schizofrenia trattati con il farmaco sperimentale aripiprazolo IM a lento rilascio per 6 mesi, rispetto a quelli che sono stati trattati con antipsicotici orali nel corso degli ultimi 6 mesi in Europa, Canada e Asia
    A.4.1Sponsor's protocol code number31-11-284
    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 SponsorOTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC
    B.1.3.4CountryUnited States
    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 supportOTSUKA PHARMACEUTICAL DEVELOPMENT & Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenterwatch
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street Address10 Winthrop Square, 5th floor
    B.5.3.2Town/ cityBoston
    B.5.3.3Post codeMA 02110
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 617 948 5100
    B.5.5Fax number001 617 948 5101
    B.5.6E-mailarrive@centerwatch.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 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 nameAripiprazole
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Powder for suspension 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.3.8INN - Proposed INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB05564MIG
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Abilify
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form 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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB05564MIG
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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: 3
    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
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form 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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB05564MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Schizophrenia
    Schizofrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    Schizofrenia
    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 14.1
    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
    To compare inpatient psychiatric hospitalization rates (proportion of subjects with > or = 1 inpatient psychiatric hospitalization[s]) between the retrospective period Months 4-6 (Weeks -12 to -24) while on oral standard-of-care (SOC) antipsychotic treatment(s) and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot
    Confrontare il tasso di ospedalizzazione in reparto di psichiatria (proporzione di soggetti con  1 ospedalizzazione in reparto di psichiatria) tra il periodo retrospettivo dei mesi 4-6 (settimane da -12 a -24) sotto terapia con antipsicotici orali standard e il periodo prospettico di fase B dei mesi 4-6 (settimane da 12 a 24) dopo il passaggio ad aripiprazolo i.m. a lento rilascio.
    E.2.2Secondary objectives of the trial
    To further evaluate long-term safety and tolerability of aripiprazole IM depot
    Valutare ulteriormente la sicurezza e la tollerabilità a lungo termine di aripiprazolo i.m. a lento rilascio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects who are able to provide written informed consent. If the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requires consent by a legally acceptable representative (LAR) in addition to the subject, all required consents must be obtained prior to the initiation of any protocol-required procedure. 2) Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent. 3) Subjects with a current diagnosis of schizophrenia as defined by DSMIV- TR criteria and a history of the illness for at least 1 year (12 months) prior to screening from a reliable source (eg, subject, family member, friend, caregiver, healthcare provider, or medical records). 4) Subjects who in the investigator's judgment would benefit from extendeSubjects who will be able to produce at least 7 months retrospective data by records or a reliable source, pertaining to all hospitalizations and interventions (psychiatric and nonpsychiatric). 6) Subjects who have at least 1 inpatient psychiatric hospitalization in the 2 years (24 months) prior to screening, but have been managed as outpatients for the 4 weeks prior to signing the ICF and for the full duration of the screening period. 7) Subjects must have been on oral antipsychotic treatment for the full 7 months prior to the screening phase. 8) Subjects who showed response to antipsychotic treatment (other than clozapine), according to the investigator's opinion. 9) In the investigator's opinion, subjects who are able to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, aripiprazole IM depot injection, and discontinuation of prohibited concomitant medications; who can read and understand the written word in order to complete subject-reported outcomes measures; and who can be reliably rated on assessment scales.
    1)Soggetti che sono in grado di fornire il consenso informato scritto. Nel caso in cui il comitato di revisione istituzionale o il comitato etico richiedano il consenso da parte di un rappresentate legale accettabile in aggiunta a quello fornito dal soggetto, tutti i consensi richiesti devono essere acquisiti prima dell'inizio di qualsivoglia procedura richiesta dal protocollo.
    2)Soggetti di sesso maschile e femminile tra i 18 e i 65 anni, compresi, al momento del consenso informato
    3) Soggetti con diagnosi attuale di schizofrenia secondo i criteri di definizione del DSM-IV-TR e una storia di patologia per almeno 1 anno (12 mesi) prima dello screening da una fonte attendibile (per esempio, il soggetto stesso, familiari, amici, assistente, operatori sanitari, cartelle cliniche).
    4) Soggetti che secondo le valutazioni del ricercatore otterrebbero benefici dalla prosecuzione del trattamento con una formulazione iniettabile a lunga durata d’azione.
    5) Soggetti che saranno in grado di produrre dati retrospettivi per almeno 7 mesi con cartelle cliniche o fonti attendibili, riguardanti tutte le ospedalizzazioni e tutti gli interventi (psichiatrici e non psichiatrici).
    6) Soggetti che sono stati sottoposti ad almeno 1 ospedalizzazione in reparto di psichiatria nei 2 anni (24 mesi) precedenti lo screening, ma che sono stati trattati ambulatorialmente nelle 4 settimane prima di firmare il modulo per il consenso informato e per tutta la durata del periodo di screening.
    7) I soggetti devono essere stati sotto trattamento con antipsicotici orali per tutti i 7 mesi precedenti la fase di screening.
    8) Soggetti che hanno mostrato una risposta al trattamento con antipsicotici (diversi dalla clozapina) secondo l’opinione del ricercatore.
    9) Secondo l’opinione del ricercatore, soggetti che sono in grado di comprendere la natura dello studio e di seguire i dettami del protocollo, compresi i regimi di dosaggi prescritti, l'assunzione delle compresse, l'iniezione di aripiprazolo i.m. a lento rilascio e l'interruzione di farmaci concomitanti proibiti; che sono in grado di leggere e comprendere quanto scritto al fine di compilare le misurazioni dei risultati auto-riportate; e che possono essere classificati in maniera affidabile con le scale di valutazione.
    E.4Principal exclusion criteria
    ) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or have been incarcerated in the past 7 months 2) Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the trial. 3) Any subject who requires or may need any other antipsychotic medications during the course of the trial, other than allowed rescue medication. 4) Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones. 5) Subjects with a history of hypersensitivity to antipsychotic agents. 6) Subjects deemed intolerant of receiving injectable treatment. 7) Subjects who have received electroconvulsive therapy within the last 7 months prior to screening. 8) Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator. 9) Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. 10) Subjects requiring hospitalization for any psychiatric reason during the 4 weeks prior to signing the ICF or during the screening period. 11) Subjects without at least 1 inpatient psychiatric hospitalization in the last 2 years (24 months) prior to screening. 12) Subjects who have met DSM-IV-TR criteria for any significant substance use disorder within 3 months prior to screening. 13) Subjects who are considered treatment-resistant to antipsychotic medication other than clozapine. 14) Treatment with long-acting injectable antipsychotics (eg, haloperidol decanoate, fluphenazine decanoate, risperidone long-acting injection [Risperdal Consta], paliperidone palmitate extended-release injectable suspension [Invega Sustenna], olanzapine for extended-release injectable suspension [Zyprexa Relprevv]), in which the last dose was within 7 months prior to screening. 15) Subjects who have not been treated with oral antipsychotics for 7 months prior to screening. 16) Subjects who have a significant risk of committing suicide based on history, routine psychiatric status examination, investigator’s judgment, or who have an answer of “yes” on questions 4 or 5 (current or over the last 30 days) on the baseline version of the Columbia Suicide Severity Rating Scale (C-SSRS). 17) Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the clinical judgment of the investigator. 18) Sexually active males who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 180 days following the last dose of trial medication, or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 150 days following the last dose of trial medication. Abstinence will be permitted if it is confirmed and documented at every trial visit. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injections, implant, condom or sponge with spermicide. Note: Women of child bearing potential (WOCBP) is defined as all women unless they have had an oophorectomy and/or hysterectomy or have been menopausal for 12 consec
    1)Non devono essere arruolati nel presente studio detenuti o soggetti che sono detenuti obbligatoriamente (rinchiusi contro la loro volontà) o che sono stati detenuti per qualsiasi ragione nei 7 mesi precedenti.
    2)Soggetti per cui potrebbero rendersi necessari durante
    lo studio potenti inibitori di CYP2D6 o CYP3A4 o induttori di CYP3A4.
    3)Tutti i soggetti che necessitano o potrebbero necessitare di qualsiasi altro farmaco antipsicotico nel corso dello studio, diverso dai farmaci di soccorso consentiti.
    4)I soggetti di cui si conosce allergia, intolleranza o mancata risposta a precedenti trattamenti con aripiprazolo o altri chinolinoni.
    5)I soggetti che hanno una storia di ipersensibilità agli agenti antipsicotici.
    6)soggetti che sono stati considerati intolleranti ai trattamenti per iniezione.
    7)soggetti che sono stati sottoposti a terapia elettroconvulsiva nei 7 mesi precedenti lo screening.
    8)soggetti con storia di sindrome neurolettica maligna o con discinesia tardiva clinicamente significativa secondo le valutazioni del ricercatore.
    9)soggetti con diagnosi concomitante di patologia diversa dalla schizofrenia secondo i criteri del DSM-IV-TR, compresi disordini schizoaffettivi, disturbi depressivi maggiori, disturbo bipolare, delirio, demenza o altri disturbi cognitivi e amnestici. Inoltre, soggetti con disturbi di personalità borderline, paranoide, istrionico, schizotipico, schizoide o antisociale.
    10) soggetti che hanno richiesto l’ospedalizzazione per qualsivoglia ragione psichiatrica durante le 4 settimane precedenti la firma del modulo per il consenso informato o durante il periodo di screening.
    11) I soggetti senza almeno 1 ospedalizzazione in reparto di psichiatria negli ultimi 2 anni (24 mesi) precedenti lo screening.
    12) I soggetti che in base ai criteri del DSM-IV-TR hanno fatto un significativo abuso di sostanze nei 3 mesi precedenti lo screening.
    13) I soggetti che sono stati considerati resistenti al trattamento con farmaci antipsicotici diversi dalla clozapina.
    14) Trattamento con antipsicotici iniettabili a lunga durata d’azione (per esempio aloperidolo decanoato, flufenazina decanoato, risperidone iniettabile a rilascio prolungato [Risperdal Consta], paliperidone palmitato sospensione iniettabile a rilascio prolungato
    [Invega Sustenna], olanzapina sospensione iniettabile a rilascio prolungato [ZyprexaRelprevv]), la cui ultima somministrazione è stata effettuata nei 7 mesi precedenti lo screening.
    15) I soggetti che non sono stati trattati con antipsicotici orali nei 7 mesi precedenti lo screening.
    16) I soggetti con rischio significativo di suicidio in base all’anamnesi, all’esame periodico sulle condizioni psichiatriche, alle valutazioni del ricercatore, o che hanno risposto “sì” alle domande 4 e 5 (attualmente o negli ultimi 30 giorni) della versione basale della scala di valutazione C-SSRS (Columbia Suicide Severity Rating Scale).
    17) I soggetti che hanno storia o evidenza di condizioni cliniche che li esporrebbero a un indebito rischio di un evento avverso significativo o che potrebbero interferire con le valutazioni di sicurezza ed efficacia durante lo studio, compresa ma non limitata alla patologia epatica, renale, respiratoria, cardiovascolare, endocrina, neurologica, ematologia o immunologica in base alle valutazioni cliniche del ricercatore.
    18) Gli uomini sessualmente attivi che non si impegneranno ad utilizzare 2 dei metodi di controllo delle nascite approvati o che non si asterranno dai rapporti durante lo studio e per 180 giorni dopo l’ultima dose del farmaco oggetto dello studio, o le donne sessualmente attive in età fertile che non si impegneranno a utilizzare 2 dei metodi di controllo delle nascite approvati o che si asterranno dai rapporti durante lo studio e per 150 giorni dopo l'ultima dose del farmaco oggetto dello studio. L’astinenza sarà
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: The primary endpoint of this trial is the comparison of inpatient psychiatric hospitalization rates (proportion of subjects with ≥ 1 inpatient psychiatric hospitalization[s]) between the retrospective period Months 4-6 (Weeks -12 to -24) while on oral SOC antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after switch to aripiprazole IM depot
    Efficacia: L’endpoint primario del presente studio è il confronto del tasso di ospedalizzazione in reparto di psichiatria (percentuale di soggetti con ≥ 1 ospedalizzazione in reparto di psichiatria) tra il periodo retrospettivo di 4-6 mesi (settimane da -12 a -24) in terapia con antipsicotici orali standard e il periodo prospettico di fase B di 4 - 6 mesi (settimane da 12 a 24) dopo il passaggio ad aripiprazolo i.m. a lento rilascio
    E.5.1.1Timepoint(s) of evaluation of this end point
    The analysis will be performed using a McNemar test on those who have hospitalization data during months 4-6 prior to the 4-week outpatient treatment period before study entry and during months 4-6 after switch to aripiprazole IM depot. Please see protocol for more details
    L'analisi sarà eseguita con un test di McNemar su coloro che hanno dati di ospedalizzazione nei 4-6 mesi precedenti il periodo di 4 settimane di trattamento ambulatoriale, prima dell'ingresso nello studio e durante i 4-6 mesi dopo il passaggio al trattamento con aripiprazolo IM deposito. Fare riferimento al protocollo per maggiori dettagli
    E.5.2Secondary end point(s)
    The last 3 months of the retrospective and prospective (Phase B) treatment periods will be compared in the analysis of the following endpoints: - Number of inpatient psychiatric hospitalizations per subject. - Cumulative duration of inpatient psychiatric hospitalizations. - Mean duration of inpatient psychiatric hospitalizations. - Number and mean duration of all other (non-inpatient) psychiatric treatment visits including, but not limited to, partial hospitalizations, intensive outpatient programs, assertive community treatment programs, emergency room visits, hospitalizations for psychosocial reasons, etc. - Number of inpatient nonpsychiatric hospitalizations per subject. - Cumulative duration of inpatient nonpsychiatric hospitalizations. - Mean duration of inpatient nonpsychiatric hospitalizations. - Number and mean duration of all other (outpatient or non-inpatient) nonpsychiatric treatment visits including, but not limited to, emergency room visits. In addition, the following endpoints will be assessed in Phase B: - Mean change from baseline (Day 0) to Week 24 in PANSS total score. - Mean change from baseline (Day 0) to Week 24 in PANSS positive and negative subscale scores. - Mean change from baseline (Day 0) to Week 24 in CGI-S score. - Mean CGI-I score at Week 24. - Discontinuation rate due to all causes. - Time to discontinuation due to all causes. - Proportion of responders (ie, defined as > or = 30% decrease from baseline in PANSS total score or a score of 1 [very much improved] or 2 [much improved] on the CGI-I scale). - Mean change from baseline (Day 0) to Week 24 in QLS score. - Mean change from baseline (Day 0) to Week 24 in SWN-S score. - Mean change from baseline (Day 0) to Week 24 in DAI total score. - Mean change from baseline (Day 0) to Week 24 in IWQoL-Lite total score. - Mean change from baseline (Day 0) to Week 24 in IAQ total score. Safety Endpoints: Adverse events will be examined by frequency, severity, seriousness, and discontinuation (all cause and due to AEs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be completed at baseline and all subsequent visits to assess the risk of suicide events and to classify reported suicide events. Injection site pain will be assessed by mean visual analogue scale (VAS) scores as reported by the subject after each injection in Phase B. The investigator rating of localized pain, redness, swelling, and induration at the injection site will also be tabulated. The incidence of clinically significant changes will be calculated for vital signs and routine laboratory tests. Mean change from baseline and incidence of clinically significant changes will be calculated for ECG parameters, prolactin concentrations, lipid/metabolic profile (fasting glucose, fasting total cholesterol, fasting high density lipoprotein (HDL), fasting low density lipoprotein (LDL), fasting triglycerides) and body weight. A central ECG service will be utilized to review all ECGs in order to standardize interpretations for the safety analysis. Extrapyramidal symptoms will be evaluated by calculating mean change from baseline in the Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), and Barnes Akathisia Rating Scale (BARS). By-subject listings of physical examination findings will be reviewed as a further assessment of safety
    Gli ultimi 3 mesi dei periodi di trattamento retrospettivo e prospettico (fase B) saranno confrontati nell’analisi dei seguenti endpoint:
    •Numero di ospedalizzazioni in reparto di psichiatra per soggetto
    •Durata complessiva delle ospedalizzazioni in reparto di psichiatria
    •Durata media delle ospedalizzazioni in reparto di psichiatria
    •Numero e durata media di tutte le altre visite per trattamenti psichiatrici (non come paziente ospedalizzato) compresi, ma non limitati a, ospedalizzazione parziale, programmi ambulatoriali intensivi, programmi ACT (assertive community treatment – presa in carico intensiva sul territorio), visite al Pronto soccorso, ospedalizzazione per ragioni psicosociali eccetera
    •Numero di ospedalizzazioni in reparti diversi dalla psichiatria per soggetto.
    •Durata complessiva delle ospedalizzazioni in reparti diversi dalla psichiatria
    •Durata media delle ospedalizzazioni in reparti diversi dalla psichiatria.
    •Numero e durata media di tutte le altre visite per trattamenti non psichiatrici (ambulatoriali o come paziente esterno), comprese, ma non limitate a, le visite al Pronto soccorso.
    Inoltre, nella fase B:
    •Variazione media rispetto al basale (giorno 0) alla settimana 24 secondo il punteggio totale PANSS
    •Variazione media rispetto al basale (giorno 0) alla settimana 24 secondo i punteggi alle sottoscale positiva e negativa di PANSS
    •Variazione media rispetto al basale (giorno 0) alla settimana 24 secondo il punteggio CGI-S
    •Punteggio medio CGI-I alla settimana 24
    •Tasso di abbandono dello studio dovuto a tutte le cause
    •Periodo di abbandono dello studio dovuto a tutte le cause.
    •Proporzione dei pazienti responder (definita come variazione  30% rispetto al basale secondo il punteggio totale PANSS o un punteggio di 1 [molto migliorati] o di 2 [migliorati] alla scala CGI-I)
    •Variazione media rispetto al basale (giorno 0) alla settimana 24 secondo il punteggio QLS.
    •Variazione media rispetto al basale (giorno 0) alla settimana 24 secondo il punteggio SWN-S.
    •Variazione media rispetto al basale (giorno 0) alla settimana 24 secondo il punteggio totale DAI
    •Variazione media rispetto al basale (giorno 0) alla settimana 24 secondo il punteggio totale IWQoL-Lite.
    • Variazione media rispetto al basale (giorno 0) alla settimana 24 secondo il punteggio totale IAQ.

    Sicurezza:
    Gli eventi avversi saranno esaminati tenendo conto di frequenza, severità, gravità e abbandono (per tutte le cause e dovuto a EA). La C-SSRS sarà compilata al basale e durante tutte le visite successive per valutare il rischio di suicidio e per classificare i casi di suicidio riportati.
    L’incidenza di variazioni clinicamente significative sarà calcolata tenendo conto di segni vitali e test di laboratorio di routine. La variazione media rispetto al basale e l’incidenza di variazioni clinicamente significative saranno calcolate per parametri ECG, concentrazioni di prolattina, profilo lipidico/ metabolico (glucosio a digiuno, colesterolo totale a digiuno, HDL [lipoproteine ad alta densità] a digiuno, LDL [lipoproteine a bassa densità] a digiuno, trigliceridi a digiuno), e peso corporeo. Un servizio centrale di ECG sarà utilizzato per revisionare tutti gli ECG al fine di standardizzare le interpretazioni per l’analisi di sicurezza. I sintomi extrapiramidali saranno valutati calcolando la variazione media rispetto al basale con le scale SAS, AIMS e BARS, dove applicabile. Il dolore al sito dell’iniezione sarà valutato in base ai punteggi medi VAS riportati dal soggetto dopo ogni iniezione e a ogni visita dello studio. Le valutazioni del ricercatore su dolore localizzato, rossore, gonfiore e indurimento al sito dell’iniezione saranno catalogate in tabelle anche per quanto concerne le valutazioni al sito post-iniezione a ogni visita. Saranno revisionati anch
    E.5.2.1Timepoint(s) of evaluation of this end point
    For a complete schedule of assessments please see the following tables in the protocol: - Table 3.6.1 (Screening and phase A) - Table 3.6.2 (Phase B) - Table 3.6.3 (Phase C)
    Per il programma completo delle valutazioni fare riferimento alle seguenti tabelle nel protocollo:
    - Tabella 3.6.1 (screening e fase A)
    - Tabella 3.6.2 (fase B)
    - Tabella 3.6.3 (fase C)
    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 Yes
    E.6.13.1Other scope of the trial description
    quality of life
    qualità della vita
    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) 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.8.2.4Number 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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA95
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    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 End of Trial Date is defined as the last Date of Contact or the Date of Final Contact Attempt from the Post-treatment Follow-up eCRF page for the last subject completing or withdrawing from the trial
    La Fine dello Studio è definita è definita come la data dell' Ultimo Contatto o la data del tentativo di contatto finale come riportata in eCRF pag. "follow-up post-trattamento" per l'ultimo soggetto che ha completato o uscito dallo studio
    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 months37
    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 months37
    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.1.1Number of subjects for this age range: 0
    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: 600
    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 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 state195
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 600
    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)
    Standard of Care
    Trattamento di cura standard
    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 Decision2012-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-05-24
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