Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The growing number of medications used to treat attention-deficit/hyperactivity disorder (ADHD) raises important questions about whether different medications have similar or different therapeutic mechanisms of action. We have recently shown that the stimulant methylphenidate (MPH) and the non-stimulant atomoxetine (ATX) produce clinical improvement via a common mechanism in motor cortex, and distinct actions in frontostriatal and midline cingulate-precuneus regions. These exciting findings offer a window into the common and unique neurophysiological mechanisms of response to stimulant and non-stimulant treatments. However, the interpretation and clinical utility of these results would be greatly enhanced by in-depth investigation of the impact of the two treatments on relevant neural networks, and analyses which evaluate whether improvement is achieved via normalization or other adaptive changes in brain function.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Atomoxetine Hydrochloride; Central Nervous System Stimulants; Methylphenidate

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.