Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?
Placebo
+ Adderall XR 5mg
+ Adderall XR 10 mg
Enfermedades Autoinmunes+4
+ Trastornos Mentales
+ Trastornos Cognitivos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 2012
Fecha en la que se inscribió al primer participante.Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis (MS) and can occur independently of physical disability. It is the most common reason, along with physical fatigue, for MS patients to stop working. The most frequent complaint is problems with multi-tasking or thinking quickly, which corresponds to impairment in the cognitive domain of processing speed. Currently there is treatment available to prevent relapses and physical disability but there are no medications that have been shown to treat cognitive impairment. Amphetamines have been beneficial for selective attention and processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain injury. This is study will determine whether Adderall XR improves objective measures of processing speed and attention in MS patients impaired in this cognitive domain, by comparing two doses of Adderall XR (5 and 10mg) to placebo before and after the medication is administered. The results of this study will help provide data to design a larger study to determine if Adderall XR, and potentially other amphetamine drugs, will help treat cognitive impairment in MS patients.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 70 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 59 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: - Males/Females who are ≥ 18 years old and ≤ 59 years old Relapsing Remitting, Secondary Progressive or Primary Progressive MS, as per revised McDonald's Criteria Have not received corticosteroids in last thirty days or a relapse in the last ninety days An Expanded Disability Status Scale (EDSS) of ≤ 6.5 If female, must neither be pregnant nor breast-feeding Exclusion Criteria: - Have evidence of other medical cause(s) of cognitive impairment Have evidence of major depression as determined by a positive Beck Depression Index-Fast screen ≥ 13and/or by clinician interview or evidence of severe fatigue with a Fatigue Severity Scale ≥ 5. Have demonstrated a hypersensitivity to amphetamines in the past Have uncontrolled or labile hypertension (> 135/85 mm Hg, treated or untreated) Have a history of structural heart disease, including atherosclerosis or angina Have a diagnosis of bipolar disorder or a history of a psychotic episode The following medications are not permitted to be used within 14 days the study Monoamine Oxidase Inhibitors Sympathomimetics or methadone Antipsychotic agents Modafinil The following medications are permitted if the dose has been stable for ≥ 28 days Short acting benzodiazepines, qhs administration only Anticonvulsants, including gabapentin and pregabalin Bupropion Tricyclic Antidepressants Anti-spasmodics such as baclofen or tizanidine Anticholinergic medication Selective serotonin(-norepinephrine) reuptake inhibitors
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
33.333333333333336% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
PlaceboGrupo II
Comparador ActivoGrupo III
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
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
London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)
London, CanadaAbrir London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood) en Google Maps