Clinical Trials Logo

Clinical Trial Summary

Children with Attention-Deficit/Hyperactivity Disorder (ADHD) are typically treated with two types of medications with differing mechanisms of action: stimulants and non-stimulants. The stimulant Vyvanse (lisdexamfetamine, LDX), and the non-stimulant Intuniv (extended-release guanfacine, GXR), are both FDA approved treatment for ADHD. Clinical trials have shown that both medications are effective in reducing ADHD symptoms, although the neurobiological mechanisms by which Vyvanse and Intuniv produce these effects remain unknown. The aim of this study is to examine the mechanisms by which LDX and GXR reduce symptoms in patients with ADHD. MRI scanning will be used to identify treatment-related changes in brain structure and function.


Clinical Trial Description

Children with ADHD and age and sex-matched healthy controls will be scanned at the beginning of the study. In this first part of the study, MRI findings will be compared between the two groups to see whether brain functioning of children with ADHD differs from that of healthy children. In the second part of the study, the children with ADHD will meet weekly with the study doctor and be administered either extended-release guanfacine (Intuniv) or lisdexamfetamine (Vyvanse) for 6 weeks. Selection into either treatment group will be randomly determined. At the end of the study, the children with ADHD treated with either medication will have a second MRI scan. The findings of that second MRI scan will be compared to the first MRI scan in order to examine brain changes due to the medication. These second MRI scans will also be compared to the scans of the healthy controls. ;


Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis

NCT number NCT02259517
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Terminated
Phase N/A
Start date September 2014
Completion date November 6, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT06129396 - Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD) N/A
Completed NCT04779333 - Lifestyle Enhancement for ADHD Program 2 N/A
Recruiting NCT05935722 - Evaluation of a Home-based Parenting Support Program: Parenting Young Children N/A
Completed NCT03148782 - Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase N/A
Completed NCT04832737 - Strength-based Treatment Approach for Adults With ADHD N/A
Recruiting NCT04631042 - Developing Brain, Impulsivity and Compulsivity
Recruiting NCT05048043 - Development of a Game-supported Intervention N/A
Completed NCT03337646 - Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism Phase 4
Not yet recruiting NCT06080373 - Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial N/A
Completed NCT02911194 - a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD) N/A
Completed NCT02477280 - Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance Phase 4
Completed NCT02473185 - Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the QbTest Phase 4
Completed NCT02829970 - Helping College Students With ADHD Lead Healthier Lifestyles N/A
Completed NCT02555150 - A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD Phase 3
Completed NCT02390791 - New Technologies to Help Manage ADHD N/A
Completed NCT02780102 - Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD N/A
Recruiting NCT04296604 - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations N/A
Recruiting NCT04175028 - Neuromodulation of Executive Function in the ADHD Brain N/A
Completed NCT02580890 - Role of Transcranial Direct Current Stimulation (tDCS) in Patients With Attention Deficit Hyperactivity Disorder (ADHD) N/A
Completed NCT05138224 - Prevalence of Autistic Spectrum Disorder (ASD) in Children With Haemophilia