Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia
11 de junio de 2007 actualizado por: Eli Lilly and Company
A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia
Key objectives of this clinical study are to:
- Determine how well intramuscular (IM) olanzapine depot works compared to placebo
- Evaluate the safety and tolerability of IM olanzapine depot compared to placebo
- Evaluate different doses of IM olanzapine depot compared to placebo to identify the best dose(s).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
402
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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Zagreb, Croacia
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician.
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California
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National City, California, Estados Unidos
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Orange, California, Estados Unidos
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Rosemead, California, Estados Unidos
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San Diego, California, Estados Unidos
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Santa Ana, California, Estados Unidos
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Colorado
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Denver, Colorado, 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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Bradenton, Florida, Estados Unidos
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Hawaii
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Honolulu, Hawaii, 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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Louisiana
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Lake Charles, Louisiana, Estados Unidos
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Maryland
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Baltimore, Maryland, Estados Unidos
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Rockville, Maryland, Estados Unidos
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Michigan
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St. Louis, Michigan, Estados Unidos
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Missouri
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Kansas City, Missouri, Estados Unidos
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Nevada
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Las Vegas, Nevada, Estados Unidos
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Reno, Nevada, Estados Unidos
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New Jersey
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Clementon, New Jersey, Estados Unidos
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New York
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Lawrence, New York, Estados Unidos
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New York, New York, Estados Unidos
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Rochester, New York, Estados Unidos
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Staten Island, New York, Estados Unidos
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Ohio
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Beachwood, Ohio, Estados Unidos
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Chagrin Falls, Ohio, Estados Unidos
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos
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Pennsylvania
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Norristown, Pennsylvania, Estados Unidos
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Philadelphia, Pennsylvania, Estados Unidos
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South Carolina
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Columbia, South Carolina, Estados Unidos
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Travelers Rest, South Carolina, Estados Unidos
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Texas
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Houston, Texas, Estados Unidos
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Kirkland, Texas, Estados Unidos
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San Antonio, Texas, Estados Unidos
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Washington
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Kirkland, Washington, Estados Unidos
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Moscow, Federación Rusa
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St. Petersburg, Federación Rusa
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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 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients must have schizophrenia and be experiencing a psychotic episode
- Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent
- Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry
- Female patients must not be pregnant or breast-feeding
- Female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia
Exclusion Criteria:
- Patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator
- One or more seizures without a clear and resolved etiology is exclusionary. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered.
- Treatment with clozapine within 4 weeks prior to visit 1
- DSM-IV or DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days
- Treatment with remoxipride within 6 months (180 days) prior to visit 1
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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Demonstrate superiority of IM olanzapine depot 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks dosages compared with placebo in the treatment of patients with schizophrenia
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Medidas de resultado secundarias
Medida de resultado |
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To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in CGI-I
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To determine the earliest time point at which 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot show superior clinical improvement compared with placebo
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To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in CGI-S
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To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in terms of change in PANSS Positive, PANSS Negative and PANSS General Psychopathology subscales
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To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in change from baseline to endpoint in quality of life
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To evaluate the safety and tolerability of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo
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To characterize the pharmacokinetics of olanzapine following multiple dosing with IM olanzapine depot at each of the prescribed dosing regimens
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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
- Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.
- McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45.
- Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.
- Detke HC, Zhao F, Witte MM. Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia: an insight from effect size comparison with historical oral data. BMC Psychiatry. 2012 May 30;12:51. doi: 10.1186/1471-244X-12-51.
- Witte MM, Case MG, Schuh KJ, Ascher-Svanum H. Effects of olanzapine long-acting injection on levels of functioning among acutely ill patients with schizophrenia. Curr Med Res Opin. 2012 Mar;28(3):315-23. doi: 10.1185/03007995.2012.657300. Epub 2012 Jan 31.
- Ascher-Svanum H, Zhao F, Detke HC, Nyhuis AW, Lawson AH, Stauffer VL, Montgomery W, Witte MM, McDonnell DP. Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia. BMC Psychiatry. 2011 Sep 23;11:152. doi: 10.1186/1471-244X-11-152.
- Lauriello J, Lambert T, Andersen S, Lin D, Taylor CC, McDonnell D. An 8-week, double-blind, randomized, placebo-controlled study of olanzapine long-acting injection in acutely ill patients with schizophrenia. J Clin Psychiatry. 2008 May;69(5):790-9. doi: 10.4088/jcp.v69n0512. Erratum In: J Clin Psychiatry. 2011 Aug;72(8):1157.
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 junio de 2004
Finalización del estudio (Actual)
1 de abril de 2005
Fechas de registro del estudio
Enviado por primera vez
26 de julio de 2004
Primero enviado que cumplió con los criterios de control de calidad
27 de julio de 2004
Publicado por primera vez (Estimar)
28 de julio de 2004
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de junio de 2007
Última actualización enviada que cumplió con los criterios de control de calidad
11 de junio de 2007
Última verificación
1 de junio de 2007
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Espectro de esquizofrenia y otros trastornos psicóticos
- Esquizofrenia
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Antieméticos
- Agentes Gastrointestinales
- Agentes antipsicóticos
- Agentes tranquilizantes
- Drogas psicotropicas
- Inhibidores de la captación de serotonina
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes de serotonina
- Olanzapina
Otros números de identificación del estudio
- 5984
- F1D-MC-HGJZ
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. .