E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Schizophrenia |
Esquizofrenia |
|
E.1.1.1 | Medical condition in easily understood language |
Schizophrenia |
Esquizofrenia |
|
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. |
evaluar la seguridad y tolerabilidad a largo plazo del aripiprazol una vez al mes (400 o 300 mg/mes) en pacientes con esquizofrenia que completaron el estudio 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. |
? evaluar la eficacia del aripiprazol administrado una vez al mes (400 o 300 mg/mes) durante un período de 24 semanas en pacientes con esquizofrenia que completaron el estudio 14724A sobre: ? la satisfacción subjetiva con el tratamiento ? la impresión clínica global ? la calidad de vida relacionada con la salud |
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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. |
? El paciente ha recibido tratamiento con aripiprazol una vez al mes y ha completado el estudio 14724A. ? A criterio del investigador, el paciente obtendría beneficio del tratamiento de 24 semanas con aripiprazol una vez al mes. ? El paciente es capaz de leer y comprender el documento de consentimiento informado. ? El paciente ha firmado el nuevo documento de consentimiento informado específico para este estudio de extensión, el estudio 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. |
? Al paciente se le ha diagnosticado un trastorno psiquiátrico distinto de esquizofrenia durante el estudio 14724A. ? A criterio del investigador, el paciente presenta un riesgo significativo de suicidio, o si en la C-SSRS de la visita basal II: ? ha respondido «Sí» a la pregunta 4 o 5 de la sección «Ideación suicida», O ? ha respondido «Sí» a cualquiera de las preguntas de la sección «Conducta suicida». ? El paciente presenta un acontecimiento adverso moderado o severo en curso relacionado con el IMP del estudio 14724A que el investigador considera un posible riesgo para la seguridad. |
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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 |
? Acontecimientos adversos ? Clasificación de C-SSRS según las definiciones de C-CASA (1, 2, 3, 4 y 7) |
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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 |
Hasta 24 semanas y un seguimiento de seguridad de 4 semanas |
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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 |
? Bienestar subjetivo con neurolépticos - versión abreviada (SWN-S) ? Escala de impresión clínica global - intensidad de la enfermedad (CGI-S) ? Escala de calidad de vida (QLS) ? Tolerabilidad y calidad de vida (TooL) ? Escala de experiencia sexual de Arizona (ASEX) ? Cuestionario sobre la disposición para trabajar (WoRQ) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline and Week 24 |
Desde la visita basal hasta la semana 24 |
|
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 | No |
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 |
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 | 12 |
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
|
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. |
El fin del estudio se define como el último contacto con el paciente especificado en el protocolo. El final definitivo del estudio se define como el último contacto con el último paciente del estudio especificado en el protocolo. |
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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 |