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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 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 127 participants.

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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.

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 Registry Record Tells You About NCT01678209

The ClinicalTrials.gov registry entry for NCT01678209 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

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

NCT01678209 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.