Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior
citalopram hydrobromide
+ placebo
Trastorno del Espectro Autista+1
+ Trastorno Autista
+ Trastornos Generalizados del Desarrollo Infantil
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 2004
Fecha en la que se inscribió al primer participante.For children with autism spectrum disorders (ASD, also known as Pervasive Developmental Disorders - PDDs), repetitive behaviors are common and frequently interfere with functioning in the home as well as in social and educational settings. These behaviors may involve repetitive movements, rigid routines, repetitive play, and even repetitive speech. These behaviors may be associated with high levels of anxiety, severe tantrums. Self-injury can occur when these behaviors and routines are interrupted. Participants will be randomly assigned to receive citalopram or placebo (administered as liquid), and carefully followed every two weeks. At the end of 12 weeks, children who have responded to treatment will be given the opportunity to continue in the study, with monthly visits, for an additional 24 weeks. Children who received placebo and did not respond to treatment at 12 weeks will be given the opportunity to receive a carefully monitored 12 week course of citalopram.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 149 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 5 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: * Able to walk * Diagnosis of Autistic Disorder, Asperger's Disorder, or PDD-NOS * Have a score greater than or equal to (\>) 8 on the sum of items 1A, 2, 3 and 5 of the Compulsions Subscale of the Revised CYBOCS. * Have a rating of at least moderate behavioral disturbance based on the modified Clinical Global Impression-Severity of Illness score (CGI-S) at the time of screening (See description below). * Be free of psychotropic medication for at least one month for fluoxetine, two weeks for other SSRIs and neuroleptics, and for 5 days for stimulants prior to baseline ratings. * Be judged reliable for medication compliance and agree to keep appointments for study contacts and tests as outlined in the protocol (both subject and guardian(s)). Exclusion Criteria: * Medical contraindications to therapy with SSRIs * Prior exposure to citalopram (or escitalopram) of sufficient dose or duration to determine response status * History of treatment failure to a clinically adequate trial of two select SSRIs * Diagnosis of Rett's Disorder or Childhood Disintegrative Disorder * Uncontrolled epilepsy, with a seizure within past 6 months * Child weighs less than (\<) 15 kg at screening contact. * Pregnancy * Presence of chronic medical conditions that might interfere with study participation or where study participation would be contraindicated * Clinically significant abnormal baseline laboratory testing * History of bipolar disorder or manic episode induced by antidepressant exposure * Documented need for ongoing psychotropic medications besides study medication (with the exception of stable dose (at least 3 month) anti-convulsants for seizures). * Concomitant medication that would interfere with participation in the study. * Recent (\< 2 months) initiation of behavior therapy (such as parent training, applied behavior analysis or behavior modification) in a clinic, with a private practitioner or in a school program. Participants who are in an established behavior therapy program (defined as greater than (\>) 2 months for clinic or private practitioner or greater than (\>) 1 month for school program) can be included in the study. Families will be asked not to initiate any new behavior therapy during the study.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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 6 ubicaciones
Yale University
New Haven, United StatesDartmouth-Hitchcock Medical Center
Lebanon, United StatesNorth Shore - Long Island Jewish Hospital
Great Neck, United States