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NCT01678209 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 4
Development phase
127
Enrollment target

NCT01678209: Completed Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT01678209 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 127 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01678209, a Phase 4 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 4
Development phase
127 participants
Enrollment target

Study 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.

Primary Outcome

Comparison of Go-Nogo at 6 weeks from baseline. Performance on a go-nogo task inside the scanner (fMRI). In the go/no-go task, participants respond to certain stimuli ("go" stimuli) and make no response for others ("no-go" stimuli).

Interventions

  • OTHER fMRI scans
  • DRUG Atomoxetine arm
  • DRUG Methylphenidate arm

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2012-10
Est. Completion 2018-04-30
Phase Phase 4

What the finished NCT01678209 record still lists

NCT01678209 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 3 interventions - of which fMRI scans is the first listed.

NCT01678209 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01678209 about?

NCT01678209 is a clinical study titled "Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach". 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-stimu...

What is the current status of trial NCT01678209?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 127 participants. The study started on 2012-10. Estimated completion is 2018-04-30.

What interventions are being tested in trial NCT01678209?

The interventions under investigation include: fMRI scans (OTHER), Atomoxetine arm (DRUG), Methylphenidate arm (DRUG).

Who is sponsoring clinical trial NCT01678209?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01678209's enrollment target sits among peer trials

127 639th of 2000 higher than 1,355 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01678209, the US trial registry maintained by the National Library of Medicine. NCT01678209 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.