CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 127 enrolled
Drug / intervention
Atomoxetine arm +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01678209
NCT01678209Phase 4Completed

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

Icahn School of Medicine at Mount Sinai·interventional·Posted Sep 3, 2012·Updated Jul 24, 2020

In Brief

A Phase 4 clinical trial evaluating fMRI scans, Atomoxetine arm, and 1 other intervention for Attention Deficit Hyperactivity Disorder and ADHD. Completed, enrolled 127 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 3, 2012
Enrollment StartOct 1, 2012
Primary CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 13.8 years ago

Interventions

fMRI scansother

2 fMRI scans 6-8 weeks apart

Atomoxetine armdrug

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

Methylphenidate armdrug

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