A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
2 de mayo de 2016 actualizado por: Janssen Research & Development, LLC
A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia
The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study.
The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase).
Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29.
Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo.
The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.
Tipo de estudio
Intervencionista
Inscripción (Actual)
509
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Barranquilla, Colombia
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Bogota, Colombia
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Medellin, Colombia
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Pereira, Colombia
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Deajun, Corea, república de
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Gyeongsangnam-Do, Corea, república de
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Incheon, Corea, república de
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Seongnam, Corea, república de
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Arkansas
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Little Rock, Arkansas, Estados Unidos
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California
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San Fran Cisco, California, Estados Unidos
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District of Columbia
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Washington, District of Columbia, Estados Unidos
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Florida
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Lauderhill, Florida, Estados Unidos
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Illinois
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Chicago, Illinois, Estados Unidos
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Hoffman Estates, Illinois, Estados Unidos
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Kansas
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Topeka, Kansas, Estados Unidos
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Maryland
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Baltimore, Maryland, Estados Unidos
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Mississippi
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Flowood, Mississippi, Estados Unidos
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New Jersey
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Marlton, New Jersey, Estados Unidos
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New York
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Cedarhurst, New York, Estados Unidos
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos
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Texas
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Austin, Texas, Estados Unidos
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Dallas, Texas, Estados Unidos
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Utah
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Salt Lake City, Utah, Estados Unidos
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Johor Bahru, Malasia
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Kuala Lumpur, Malasia
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Tanjong Rambutan, Malasia
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Guadajalara, México
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Mexico City, México
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Monterrey, México
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San Luis Potosi, México
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Zapopan, México
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Diyarbakir, Pavo
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Sakarya, Pavo
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Arad, Rumania
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Craiova, Rumania
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Iasi, Rumania
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Sibiu, Rumania
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Tg Mures, Rumania
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Donetsk, Ucrania
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Evpatoriya, Ucrania
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Glevakha, Ucrania
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Ivano-Frankivsk, Ucrania
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Kerch, Ucrania
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Kharkiv, Ucrania
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Kharkov, Ucrania
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Kherson, Ucrania
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Kiev, Ucrania
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Lviv, Ucrania
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Lvov, Ucrania
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Odesa, Ucrania
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Odessa, Ucrania
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Poltava, Ucrania
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Smela, Ucrania
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Ternopil, Ucrania
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Uzhgorod, Ucrania
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Vinnitsa, Ucrania
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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 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients with schizophrenia for more than 1 year
- A total score in the Positive and Negative Syndrome Scale (PANSS) < 120
- Signed informed consent
- Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
- Men must agree to use a double-barrier method of birth control
- Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
- A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
- Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
- A diagnosis of substance dependence within 6 months before screening
- History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
- Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
- Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
- Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
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
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo
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Form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
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Experimental: Paliperidone palmitate 3-month (PP3M)
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Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use.
One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Time to Relapse During the Double-Blind Phase
Periodo de tiempo: Approximately Week 60
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Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event.
Median time to relapse was estimated by the Kaplan-Meier method.
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Approximately Week 60
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
Periodo de tiempo: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).
Each item is rated 1 (absent) to 7 (extreme).
The total score ranging from 30 to 210.
Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
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Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
Periodo de tiempo: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
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Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
Periodo de tiempo: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior.
The results of the assessment were converted to a numerical score which ranges from 1 to 100.
A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.
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Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
- Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153.
- Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3.
- Gopal S, Vermeulen A, Nandy P, Ravenstijn P, Nuamah I, Buron Vidal JA, Berwaerts J, Savitz A, Hough D, Samtani MN. Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Curr Med Res Opin. 2015 Nov;31(11):2043-54. doi: 10.1185/03007995.2015.1085849. Epub 2015 Oct 2.
- Berwaerts J, Liu Y, Gopal S, Nuamah I, Xu H, Savitz A, Coppola D, Schotte A, Remmerie B, Maruta N, Hough DW. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):830-9. doi: 10.1001/jamapsychiatry.2015.0241.
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 mayo de 2012
Finalización primaria (Actual)
1 de abril de 2014
Finalización del estudio (Actual)
1 de abril de 2014
Fechas de registro del estudio
Enviado por primera vez
6 de febrero de 2012
Primero enviado que cumplió con los criterios de control de calidad
8 de febrero de 2012
Publicado por primera vez (Estimar)
9 de febrero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de mayo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
2 de mayo de 2016
Última verificación
1 de mayo de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR100717
- R092670PSY3012 (Otro identificador: Janssen Research & Development, LLC)
- 2011-004676-11 (Número EudraCT)
- U1111-1135-1969 (Otro identificador: Universal Trial Number)
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. .