A Controlled, Randomized, Double-Blind Trial of Sertraline in Patients With Frontal Lobe Dementia (FLD)
Sertraline
Trastornos Mentales+2
+ Enfermedades del Cerebro
+ Enfermedades del Sistema Nervioso Central
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1997
Fecha en la que se inscribió al primer participante.Degeneration of frontal serotonin-containing neurons occurs in frontal lobe dementia (FLD). The associated loss of serotonin transmission may contribute to the frontal lobe dysfunction associated with this disorder. FLD patients will undergo a controlled clinical trial of an orally administered serotonergic agent (Sertraline) which acts centrally to selectively block serotonin uptake to treat patients' cognitive and behavioral frontal dysfunction. Study subjects will be evaluated at regular intervals with a battery of neuropsychological and behavioral tests designed to assess frontal and other cognitive functions. In addition, compliance and levels of the medication will be measured in the blood and when possible in the cerebrospinal fluid (CSF).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 30 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Characterized as having behavioral manifestations using a standardized neuropsychiatric scale and interview. FLD patients' frontal cognitive sysfunctions characterized using a short neurobehavioral test battery. Patients must be able to be tested and cooperative with the procedures required in this protocol. No contraindications to the use of Sertraline. No medical conditions that can reasonably be expected to subject the patient to unwarranted risk (e.g., cancer) or require frequent changes in medication. Well-controlled medical conditions such as hypertension and diabetes will not be excluded. Patients must not be pregnant or nursing and must be using effective contraception, if still at child-bearing age. No history of prior severe traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury. Not using any psychotropic medication which cannot be stopped 4 weeks before the study.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, United StatesAbrir National Institute of Neurological Disorders and Stroke (NINDS) en Google Maps