- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00247637
The Genetic Basis of Inherited Neurologic Deficits in People With Schizophrenia
The Genetics of Endophenotypes and Schizophrenia
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Schizophrenia is a disabling disorder that is associated with specific inheritable neurobiologic deficits. These deficits can cause problems with memory, visual attention, information processing, and other aspects of daily living. Understanding the genetic components of these deficits in people with schizophrenia and their unaffected family members may help uncover the neurobiological basis, risk factors, and heritability of the disease. In addition, the information may serve to create more effective treatments and possibly a cure for the disease. This study will serve to provide information about the genetic basis of known inherited neurobiological deficits in people with schizophrenia. In turn, this may guide further studies on the genetics of schizophrenia.
Participants will attend 2 study visits, each of which will last approximately 4 hours. The first will include blood tests and diagnostic interviews of participating families to evaluate the presence of schizophrenic symptoms. The second study visit will entail four neurocognitive and neurophysiological tests. Participants will first have a pre-pulse inhibition test, which uses electrodes to measure eye blinking. Electrodes will also be placed on participants' head, ears, and around their eyes to measure brain waves. Next, participants will undergo an oculomotor test, during which they will wear glasses fitted with sensors that record eye movement. Participants will then be asked to repeat a list of words, letters, and numbers read by a researcher. Last, participants will undergo a computerized performance test requiring them to watch the computer screen and click a mouse whenever they see a number between 0 and 9. Each study visit will take approximately 4 hours.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90073
- University of California Los Angeles
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San Diego, California, Estados Unidos, 92103
- University of California, San Diego
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Colorado
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Denver, Colorado, Estados Unidos, 80220
- University of Colorado Health Sciences Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Harvard University
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New York
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New York, New York, Estados Unidos, 10029
- Mount Sinai School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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Washington
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Seattle, Washington, Estados Unidos, 98108
- University of Washington and VA Puget Sound Health Care System
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria for Participating Families:
- Families with at least one member who has schizophrenia
Exclusion Criteria:
- N/A
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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percent inhibition to the 60 msec prepulse, P50 suppression, proportion of correct saccades, d, number correct in the reorder condition, the total recall score
Periodo de tiempo: Upon entry to the study
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The primary outcome measure for each endophenotype is as follows: for prepulse inhibition (PPI) the primary measure is the percent inhibition to the 60 msec prepulse; for P50 suppression it is the difference in amplitude between the test and conditioning stimuli; for antisaccade it is the proportion of correct saccades; for the DS-CPT it is (d') which is based on correct target detections and incorrect responses to nontargets; for LNS it is the number correct in the reorder condition; for CVLT it is the total recall score summed across 5 trials.
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Upon entry to the study
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: David Braff, MD, University of California, San Diego
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH065571 (Subvención/contrato del NIH de EE. UU.)
- DNBBS 7G-GRR
- R01MH065707 (Subvención/contrato del NIH de EE. UU.)
- R01MH065578 (Subvención/contrato del NIH de EE. UU.)
- R01MH065588 (Subvención/contrato del NIH de EE. UU.)
- R01MH065554 (Subvención/contrato del NIH de EE. UU.)
- R01MH065562 (Subvención/contrato del NIH de EE. UU.)
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. .