Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach
fMRI scans
+ fMRI scans
+ Atomoxetine arm
Mental Disorders+7
+ Nervous System Diseases
+ Neurologic Manifestations
Treatment Study
Summary
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.127 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 7 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Icahn School of Medicine at Mount Sinai
New York, United StatesOpen Icahn School of Medicine at Mount Sinai in Google Maps