Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach
fMRI scans
+ fMRI scans
+ Atomoxetine arm
Troubles Mentaux+7
+ Maladies du système nerveux
+ Manifestations Neurologiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 2012
Date à laquelle le premier participant a commencé l'étude.The specific aims of this project are to use functional magnetic resonance imaging (fMRI) to determine the significance of activation changes over treatment related to clinical improvement, and the impact of treatment on neural connectivity within and between the anti-correlated frontostriatal 'task-positive' circuit and cingulate-precuneus 'task-negative' network. Our central hypotheses are that clinical improvement is associated with: (i) normalization of reduced connectivity of regions within the 'task-positive' network, with resultant increased inhibition of motor cortex, and (ii) normalization of low task-related connectivity in regions within the task-negative network for MPH and the 'task-positive' network for ATX. This research proposes to test a model which posits a neurophysiological basis of mechanisms of response to stimulant and non-stimulant medications, and fits with our long term objectives of being able to match treatments to individual patients. Testing this model requires large samples of youth scanned using fMRI before and after treatment, and matched healthy controls also scanned twice. We will use an innovative network-based approach to study the effects of treatment, building on results from our current fMRI treatment study, and incorporating new theoretical approaches to understanding ADHD and its treatment.
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.127 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 7 à 17 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: General inclusion criteria for subjects with ADHD and healthy controls are: aged 7-17 years; Wechsler Intelligence Scale for Children (WISC) scores ≥ 75; informed consent and assent to study participation. Specific inclusion criteria for youth with ADHD are: diagnosis of ADHD, any subtype, determined by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL); ADHD Rating Scale-IV-Parent Version: Investigator Administered (ADHD-RSIV) total score ≥ 1.5 SD above age and gender means for subtype Clinical Global Impressions-ADHD-Severity (CGI-S) score > 4; ADHD must be the primary diagnosis and focus of treatment, and the treatments offered in the study must not be contraindicated for the comorbid disorder. Exclusion Criteria: General exclusion criteria are: history of head injury with loss of consciousness or any CNS disease that is likely to affect brain function; diagnosis of autism or pervasive developmental, psychotic, major mood, and Tourette's disorder; alcohol or drug abuse in the past 3 months or a positive urinary toxic screen on initial evaluation; use of psychotropic medication within 2 weeks of the study (8 weeks for fluoxetine); pre-existing medical or psychological condition which precludes being in the scanner (e.g., claustrophobia, morbid obesity); metal in the body that precludes scanning (e.g., braces, metal plate); positive urine pregnancy test. Specific exclusion criteria for the treatment trial include: previous unsuccessful trial of MPH or ATX that was adequately dosed (≥ 1 mg/kg for MPH or 1.0 mg/kg for ATX) and of adequate duration (≥ 4 weeks); abnormal findings on physical exam, or vital signs pulse and blood pressure > 95% of age and gender mean; inability to swallow capsules; weight is < 20 kg or > 85 kg. Specific exclusion criteria for control youth include: no past history or current diagnosis of any psychiatric disorder, determined by the K-SADS-PL interview; ADHD-RS-IV and CBCL scores for each symptom domain ≤ 1 SD of age and gender means.
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
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifGroupe II
ExpérimentalGroupe III
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
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
Icahn School of Medicine at Mount Sinai
New York, United StatesOuvrir Icahn School of Medicine at Mount Sinai dans Google Maps