Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis
bromocriptine
+ sertraline hydrochloride
Enfermedades del sistema nervioso+4
+ Procesos Patológicos
+ Signos y Síntomas
Estudio de Tratamiento
Resumen
PROTOCOL OUTLINE: Motor slowness (bradykinesia) and motor control are tested in repetitive behavior disorder patients and matched controls. Group differences reflecting alterations in basal ganglia dopamine function are compared. Behavioral assessments are conducted on each patient by trained observers. Assessments are taken at baseline and during the maintenance phase of drug treatment described below. The efficacy of bromocriptine in the treatment of stereotypy and self-injury is determined in a randomized, double blind, placebo controlled, crossover study extending over 20 weeks. Cohorts of 6 to 8 patients first enter into a single blind placebo phase, followed by double blind treatment with placebo or bromocriptine. The crossover manipulation entails a titration phase, a maintenance phase, then a final single blind placebo condition. The same experimental design is used to determine the efficacy of sertraline or placebo in the treatment of stereotypy and concomitant self injury and compulsions. Duration of study is 26 weeks.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 40 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.De 18 a 55 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of mental retardation High rate of stereotyped behavior, such as concomitant self-injurious and compulsive behaviors No diagnosis of tardive dyskinesia or akathisia --Prior/Concurrent Therapy-- No exposure to neuroleptics within 6 months prior to study --Patient Characteristics-- Age: 18 to 55 Hematopoietic: (for bromocriptine and sertraline treatments) No history of anemia No clinically significant hematologic disease Hepatic: (for bromocriptine and sertraline treatments) No history of hepatic abnormalities No clinically significant liver disease Renal: (for bromocriptine and sertraline treatments) No history of renal abnormalities No clinically significant renal disease Cardiovascular: (for bromocriptine and sertraline treatments) No history of hypertension No clinically significant cardiac disease Other: No history of seizure within 4 months prior to study (for bromocriptine and sertraline treatments) No history of sensitivity to ergot alkaloids (for bromocriptine treatment) No sensitivity to serotonin uptake inhibitors (for sertraline treatment) No patients with sensory deficits (for motor function assessments)
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