Research on the Effectiveness of Risperidone in Bipolar Disorder in Adolescents and Children (REACH): A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Risperidone for the Treatment of Acute Mania in Bipolar I Disorder
Colección de datos
Trastornos Bipolares y Relacionados
+ Trastornos Mentales
+ Trastorno Bipolar
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 2003
Fecha en la que se inscribió al primer participante.Subjects will be aged 10 to 17 years with a diagnosis of Bipolar I disorder and suffering from a current mixed or manic episode. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 0.5 to 2.5 mg, or oral risperidone tablets 3 to 6 mg), which will be administered daily for 3 weeks. Study medication will be increased to the target dosage during the first 7 days, then further increased within the target dosage range reached until maximum tolerated dose is reached by day 10. The maximum tolerated dose will be given for the last 12 days of the study. Risperidone (0.5 to 2.5 mg or 3 to 6 mg doses) or placebo given orally as 0.25, 0.5, 1, 2, 3, or 4 mg tablets (or matching placebo) each day for 3 weeks.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 13 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 10 a 17 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Current primary diagnosis of bipolar I disorder, mania or mixed type * Aged between 10 and 17 years * Young Mania Rating Scale score greater than or equal to 20 at screening and baseline Exclusion Criteria: * Known or suspected history of substance dependence * Significant risk for suicidal or violent behavior * Received electroconvulsive treatment within 4 weeks of baseline * Received a depot antipsychotic within 2 treatment cycle before baseline * Is unable to swallow medication taken in the form of tablets * Has a positive result for a urine drug screen done at baseline * Known or suspected seizure disorder * Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening * Known or suspected history of hypersensitivity or intolerance to risperidone * History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios