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- Ensayo clínico NCT00086320
A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.
6 de junio de 2011 actualizado por: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Evaluating Paliperidone Extended Release Tablets in the Prevention of Recurrence in Subjects With Schizophrenia
The purpose of this study is to determine the efficacy (effectiveness) and safety of paliperidone ER compared with placebo in the prevention of recurrence of symptoms of schizophrenia.
Descripción general del estudio
Descripción detallada
Paliperidone ER is currently being investigated as treatment for the acute symptoms of schizophrenia and also as maintenance treatment.
This trial is designed to evaluate efficacy and safety of paliperidone ER in prevention of recurrence of psychotic symptoms in patients with schizophrenia.
This trial is a randomized (patients will be assigned to different treatment groups based solely on chance), double-blind (neither the patient nor the physician will know if placebo or drug is being given and at what dose), placebo-controlled, parallel-group, multicenter study consisting of 5 phases: a screening phase of up to 5 days; a 8-week open-label run-in phase, during which all patients will be treated with open-label, flexibly dosed paliperidone ER (3 to 15 mg) orally once daily to identify a dose that will achieve control of their acute psychotic symptoms (only patients who maintain a stable dosage regimen and have a total Positive and Negative Syndrome Scale [PANSS] score </=70; Clinical Global Impression Scale - Severity [CGI-S] </=4; and scores of </=4 for PANSS items for delusions, conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, hostility, and uncooperativeness during the last 2 weeks of the run-in phase will be eligible to continue in the stabilization phase); a 6-week open-label stabilization phase, patients who maintain control of their acute psychotic symptoms at the paliperidone ER dosage identified during the run-in phase and meet the total PANSS score, CGI-S, and PANSS items scores throughout the stabilization phase will be randomized to receive either flexibly dosed paliperidone ER, starting at the dose maintained during the stabilization phase of the study, or placebo; a double-blind treatment phase of variable duration, during which patients will be followed until they meet either defined criteria for recurrence or the study ends; a 52-week open-label extension phase for patients who experience a recurrence event during the double-blind phase of the study, or who remain recurrence free for the entire double-blind phase of the study.
Efficacy will be assessed using the PANSS and CGI-S scores that will be collected every week, every 2 weeks, or every 4 weeks throughout.
Safety assessments include the incidence of adverse events throughout the study; measurement of vital signs (orthostatic pulse rate, orthostatic blood pressure, and temperature); and clinical laboratory tests.
In the run-in, double-blind, and open-label extension phases of the study, paliperidone ER or matching placebo will be flexibly dosed in the range 3 to 15 mg orally once a day (3, 6, 9, 12, or 15 mg/day).
The dosage in the stabilization phase will be fixed throughout at the dosage that achieved symptom control in the run-in phase.
Tipo de estudio
Intervencionista
Inscripción (Actual)
111
Fase
- Fase 3
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- DSM-IV diagnosis of schizophrenia at least 1 year before screening
- experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120
- agree to be hospitalized for a minimum of 14 days at the start of the study
- capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study
- resided at the same address continuously for at least 30 days prior to screening
- able and willing to fill out self administered questionnaires
- washout of antiparkinsonian medications, beta-blockers
- antiepileptics, lithium 3 days prior to the start of the run-in phase
Exclusion Criteria:
- DSM-IV Axis I diagnosis other than schizophrenia
- DSM-IV diagnosis of substance dependence within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
- preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
- injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
- previous history of lack of response to risperidone when acutely psychotic
- history of neuroleptic malignant syndrome
- significant risk of suicidal or violent behavior
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Time to recurrence, defined as the time between randomization to treatment in the double-blind period and the first documentation of a recurrence.
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Medidas de resultado secundarias
Medida de resultado |
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Change in PANSS total and subscale scores from randomization to each visit and to the end of the study. Change from baseline in CGI-S at each assessment time point and at endpoint. Incidence of adverse events throughout study.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ. Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies. Neuropsychiatr Dis Treat. 2020 Jun 19;16:1533-1542. doi: 10.2147/NDT.S221242. eCollection 2020.
- Weiden PJ, Kim E, Bermak J, Turkoz I, Gopal S, Berwaerts J. Does Half-Life Matter After Antipsychotic Discontinuation? A Relapse Comparison in Schizophrenia With 3 Different Formulations of Paliperidone. J Clin Psychiatry. 2017 Jul;78(7):e813-e820. doi: 10.4088/JCP.16m11308.
- Kramer M, Simpson G, Maciulis V, Kushner S, Vijapurkar U, Lim P, Eerdekens M. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol. 2007 Feb;27(1):6-14. doi: 10.1097/JCP.0b013e31802dda4a. Erratum In: J Clin Psychopharmacol. 2007 Jun;27(3):258.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2004
Finalización del estudio (Actual)
1 de agosto de 2005
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2004
Primero enviado que cumplió con los criterios de control de calidad
30 de junio de 2004
Publicado por primera vez (Estimar)
1 de julio de 2004
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de junio de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
6 de junio de 2011
Última verificación
1 de abril de 2010
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Procesos Patológicos
- Atributos de la enfermedad
- Espectro de esquizofrenia y otros trastornos psicóticos
- Esquizofrenia
- Reaparición
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes antipsicóticos
- Agentes tranquilizantes
- Drogas psicotropicas
- Agentes de serotonina
- Agentes de dopamina
- Antagonistas del receptor de serotonina 5-HT2
- Antagonistas de serotonina
- Antagonistas del receptor de dopamina D2
- Antagonistas de la dopamina
- Palmitato de paliperidona
Otros números de identificación del estudio
- CR004384
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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