Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?
Placebo
+ Adderall XR 5mg
+ Adderall XR 10 mg
Maladies Auto-immunes+8
+ Troubles Mentaux
+ Troubles de la cognition
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 2012
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.70 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 59 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
33,333% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
PlaceboGroupe II
Comparateur actifGroupe III
Comparateur actifObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)
London, CanadaOuvrir London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood) dans Google Maps