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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001064 |
E.1.2 | Term | Acute schizophrenia |
E.1.2 | System Organ Class | 100000004873 |
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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 |
To evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with acute schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria) as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6. |
Evaluar la eficacia de la lurasidona (40 mg/día y 80 mg/día) en comparación con el placebo en sujetos adolescentes con esquizofrenia aguda (diagnosticados según los criterios del Manual diagnóstico y estadístico de los trastornos mentales, 4.a ed., texto revisado [DSM-IV-TR]) medida por el cambio desde el inicio en la puntuación total de la Escala del síndrome positivo y negativo (PANSS) en la semana 6. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of lurasidone compared with placebo as measured by the change from Baseline in the Clinical Global Impression, Severity (CGI-S) at Week 6; - To evaluate the efficacy of lurasidone compared with placebo as measured by the change from Baseline in PANSS positive, negative, general psychopathology, and excitability subscale scores at Week 6; - To evaluate the efficacy of lurasidone compared with placebo in changes in quality of life as measured by the change from Baseline in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) at Week 6; - To evaluate the efficacy of lurasidone compared with placebo in changes in global functioning as measured by the change from Baseline in the Clinician-rated Children?s Global Assessment Scale (CGAS) at Week 6; - To evaluate the safety and tolerability of lurasidone at 40 mg/day and 80 mg/day. |
-Evaluar la eficacia de la lurasidona en comparación con el placebo medida por el cambio desde el inicio en la Impresión clínica global de la intensidad (CGI-S) en la semana 6. -Evaluar la eficacia de la lurasidona en comparación con el placebo medida por el cambio desde el inicio en las puntuaciones de las subescalas PANSS de síntomas positivos, negativos, psicopatología general y excitabilidad en la semana 6. -Evaluar la eficacia de la lurasidona en comparación con el placebo en los cambios en la calidad de vida medida por el cambio desde el inicio en el Cuestionario pediátrico sobre disfrute y satisfacción de la calidad de vida (PQ-LES-Q) en la semana 6. -Evaluar la eficacia de la lurasidona en comparación con el placebo en los cambios en el funcionamiento global medida por el cambio desde el inicio en la Escala de evaluación global del niño puntuada por el médico (CGAS) en semana 6. -Evaluar la seguridad y la tolerabilidad de la lurasidona a una dosis de 40 mg/día y 80 mg/día. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female subjects 13 to 17 years of age, inclusive, with DSM-IV-TR Axis I primary diagnosis of schizophrenia and confirmation of the schizophrenia diagnosis by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children (K-SADS-PL). Positive and Negative Syndrome Scale (PANSS) total score ? 70 at screening and Baseline; CGI-S ? 4 at screening and Baseline. |
Sujetos varones o mujeres de 13 a 17 años, ambos inclusive, con diagnóstico primario de esquizofrenia del Eje I del DSM-IV-TR y confirmación del diagnóstico de la esquizofrenia por medio del Programa de trastornos afectivos y esquizofrenia para niños en edad escolar (K-SADS-PL). Puntuación total de la Escala del síndrome positivo y negativo (PANSS) ? 70 en la selección y al inicio; CGI-S ? 4 en la selección y al inicio. |
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E.4 | Principal exclusion criteria |
Has an Axis I or Axis II diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.; Has a history or current diagnosis of mental retardation, neuroleptic malignant syndrome, or any neurologic disorder, severe head trauma, or any unstable medical condition. PANSS total scores ? 120 at screening or Baseline. |
Poseer un diagnóstico del Eje I o del Eje II que no sea esquizofrenia que haya sido el foco principal del tratamiento en los 3 meses siguientes a la selección; sujetos con antecedentes o diagnóstico actual de retraso mental, síndrome neuroléptico maligno o cualquier trastorno neurológico, traumatismo craneal grave o cualquier enfermedad médica inestable. Puntuaciones totales en PANSS ? 120 en la selección o al inicio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6. |
Cambio desde el inicio hasta la semana 6 en la puntuación total en la Escala del síndrome positivo y negativo (PANSS). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline through week 6 |
Desde el inicio hasta la semana 6 |
|
E.5.2 | Secondary end point(s) |
- Change from Baseline in Clinical Global Impression severity (CGI-S) scale; - Change from Baseline in PANSS positive, negative, general psychopathology, and excitability subscale scores; - Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q); - Change from Baseline in Clinician-rated Children?s Global Assessment Scale (CGAS); - Proportion of responders, where response is based on ? 20% improvement from Baseline in PANSS total score at Week 6. - Proportion of remitters, defined as subjects who have score not exceeding 3 (mild severity) for items P1, P2, P3, N1, N4, N6, G5, and G9 of the PANSS at Week 6. |
? Cambio desde el inicio en la Escala de impresión clínica global de la intensidad (CGI-S). ? Cambio desde el inicio en las puntuaciones de las subescalas PANSS de síntomas positivos, negativos, psicopatología general y excitabilidad. ? Cambio desde el inicio en el Cuestionario pediátrico sobre disfrute y satisfacción de la calidad de vida (PQ-LES-Q). ? Cambio desde el inicio en la Escala de evaluación global del niño puntuada por el médico (CGAS). ? Porcentaje de pacientes con respuesta, donde la respuesta se basa en una mejora ? 20% desde el inicio en la puntuación total PANSS en la semana 6. ? Porcentaje de pacientes en remisión, definido como aquellos sujetos con puntuaciones no superiores a 3 (leve) en los ítems P1, P2, P3, N1, N4, N6, G5 y G9 de la PANSS a la semana 6. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline through week 6 |
Desde el inicio hasta la semana 6 |
|
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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
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 |
Bulgaria |
China |
Colombia |
Italy |
Philippines |
Malaysia |
Mexico |
Puerto Rico |
Romania |
Ukraine |
Korea, Republic of |
Serbia |
Spain |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
|
End of Study (EOS): Visit 9 Week 6 |
Fin del estudio (FDE): Visita 9 semana 6 |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 50 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |