E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Schizophrenia |
Schizofrenia |
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E.1.1.1 | Medical condition in easily understood language |
Schizophrenia |
Schizofrenia |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039626 |
E.1.2 | Term | Schizophrenia |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Long-term safety and tolerability of aripiprazole once-monthly (400 or 300 mg/month) in patients with schizophrenia who completed Study 14724A. |
valutare la sicurezza e la tollerabilità a lungo termine dell'aripiprazolo una volta al mese
(400 o 300 mg/mese) in pazienti affetti da schizofrenia, che hanno completato lo studio 14724A.
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E.2.2 | Secondary objectives of the trial |
- Effectiveness of aripiprazole once-monthly (400 or 300 mg/month) over a period of 24 weeks on subjective treatment satisfaction in patients with schizophrenia who completed Study 14724A.
- Effectiveness of aripiprazole once-monthly (400 or 300 mg/month) over a period of 24 weeks on clinical global impression in patients with schizophrenia who completed Study 14724A.
- Effectiveness of aripiprazole once-monthly (400 or 300 mg/month) over a period of 24 weeks on health-related quality of life in patients with schizophrenia who completed Study 14724A. |
–valutare l'efficacia dell'aripiprazolo una volta al mese (400 o 300 mg/mese) in un periodo di 24 settimane in pazienti affetti da schizofrenia, che hanno completato lo studio 14724A, in termini di:
–soddisfazione oggettiva del trattamento
–impressione clinica globale
–qualità della vita correlata alla salute |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• The patient is judged to potentially benefit from 24-week treatment with aripiprazole once-monthly according to the clinical opinion of the investigator.
• The patient agrees to protocol-defined use of effective contraception. |
I pazienti sono stati trattati con aripiprazolo una volta al mese e hanno completato lo studio 14724A.
I pazienti, secondo il giudizio dello sperimentatore, trarrebbero beneficio dal trattamento di 24 settimane con aripiprazolo una volta al mese.
I pazienti sono in grado di leggere e comprendere il modulo di consenso informato.
I pazienti hanno firmato il nuovo modulo di consenso informato specifico di questo studio di estensione, studio 14724B.
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E.4 | Principal exclusion criteria |
• The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14724A / NCT01795547.
• The patient has a clinically significant unstable illness diagnosed during Study 14724A / NCT01795547.
• The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
• The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability or efficacy, or interfere with the conduct or interpretation of the study.
• The patient has one or more clinical laboratory test values outside the reference range, based on the blood or urine samples taken during the conduct of Study 14724A / NCT01795547 that are, in the investigator's opinion, of potential risk to the patient's safety.
• The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason. |
-Ai pazienti è stato diagnosticato un disturbo psichiatrico diverso dalla schizofrenia durante lo studio 14724A.
-I pazienti, secondo il parere dello sperimentatore, sono a rischio significativo di suicidio o, durante la visita basale II, al questionario C-SSRS:
–Rispondono “Sì” alle domande 4 o 5 della sezione sulle idee suicide, OPPURE
–Rispondono “Sì” a qualsiasi domanda della sezione sul comportamento suicida.
•I pazienti manifestano un evento avverso in corso, moderato o grave, correlato al medicinale sperimentale somministrato durante lo studio 14724A, che lo sperimentatore considera essere un rischio potenziale per la sicurezza.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Outcome Measure:
• Safety and tolerability measured with number of adverse events
• Risk of suicidality measured with Columbia-Suicide Severity Rating Scale (C-SRRS) score |
Sicurezza e tollerabilità misurati con il numero di eventi avversi;
rischio suicidiario misurato con il punteggio Columbia-Suicide Severity Rating Scale (C-SRRS).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 24 weeks and 4-week safety follow up |
Fino a 24 settimane e 4 settimane di follow up di sicurezza |
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E.5.2 | Secondary end point(s) |
• Mean change from Baseline in subjective well-being using SWN-S measured with Subjective Well-being under Neuroleptics - short version (SWN-S) total
score
• Mean change from Baseline in clinical global impression measured with Clinical Global Impression - Severity of Illness (CGI-S) score
• Mean change from Baseline in quality of life measured with Quality of Life Scale (QLS) total score
• Mean change from Baseline in quality of life using QLS measured with 4 QLS dimension scores
• Mean change from Baseline in tolerability and quality of life using TooL measured with Tolerability and Quality of Life (TooL) total score
• Mean change from Baseline to identify individuals with sexual dysfunctionmeasured with Arizona Sexual Experience Scale (ASEX) total score
• Mean change from Baseline in the patient's readiness to work measured with The Readiness for Work Questionnaire (WoRQ) total score |
•Variazione media dal basale nel benessere soggettivo utilizzando SWN-S misurato con benessere soggettivo sotto neurolettici - versione corta (SWN-S) punteggio totale;
Variazione media dal basale nel punteggio CGI – S;
Variazione media dal basale nel quality of life misurato con punteggio totale QLS (Quality of Life Scale);
Variazione media dal basale dei punteggi di 4 aree del questionario QLS;
Variazione media dal basale nella tollerabilità e QLS del punteggio totale;
Variazione media dal basale per individuare individui con disfunzione sessuale con il punteggio totale della “Arizona Sexual Experience Scale” (ASEX);
Variazione media dal basale nel punteggio del “The Readiness for Work Questionnaire” (WoRQ).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline and Week 24 |
Baseline e settimana 24. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Comparatore dello Studio A non viene utilizzato come obiettivo primario dello Studio B perchè deve e |
Comparator from Study A not used as the primary obj. of Study B is to collect longterm safety data |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Czech Republic |
Estonia |
France |
Germany |
Italy |
Spain |
Sweden |
United Kingdom |
United States |
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E.8.7 | Trial 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
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The end of the study for an individual patient is defined as the last protocol-specified contact with that patient. The overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study. |
La fine dello studio per un paziente è definita come l’ultimo contatto specifico previsto da protocollo con il paziente. La fine generale dello studio è definita come l’ultimo contatto specifico previsto da protocollo con l’ ultimo paziente in corso nello studio. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |