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

NCT01678209 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2020-07-24

Study results available
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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.

Conditions

  • Attention Deficit Hyperactivity Disorder
  • ADHD

Interventions

OTHER

fMRI scans

2 fMRI scans 6-8 weeks apart

DRUG

Atomoxetine arm

Flexible dose titration with atomoxetine prescribed at weekly visits for 6-8 weeks

DRUG

Methylphenidate arm

Flexible dose titration with methylphenidate for 6-8 weeks, with optional post study stabilization visits.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Newcorn, MD · Icahn School of Medicine at Mount Sinai

  • Kurt Schulz, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01678209 on ClinicalTrials.gov