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NCT01415440 · ClinicalTrials.gov registry record · NA

Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD

A NA study of Attention Deficit Hyperactivity Disorder, sponsored by New York State Psychiatric Institute.

Completed
Registry status
NA
Development phase
117
Enrollment target
1
Study location

NCT01415440: Completed NA study of Attention Deficit Hyperactivity Disorder, sponsored by New York State Psychiatric Institute.

NCT01415440 is a NA study of Attention Deficit Hyperactivity Disorder that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 117 participants, below the 215-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01415440, a NA study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
NA
Development phase
117 participants
Enrollment target
1
Study location

Study Summary

The aim of this study is to examine the mechanisms by which stimulant medications reduce symptoms in patients with Attention Deficit Hyperactivity Disorder (ADHD). Using Magnetic Resonance Imaging (MRI), the investigators have found that the volumes of certain brain regions are reduced in patients with ADHD. The reduced volumes were much less pronounced if patients had been treated with stimulant medications, suggesting that stimulants may reduce the symptoms of ADHD by reversing these volume reductions. In a second and related study, the investigators found that in patients with ADHD, emotional processing was normalized when patients were taking stimulant medications. Both studies point to possible mechanisms by which stimulants are effective; however, a significant limitation of these findings is that they were derived from cross-sectional studies. In this current study, the investigators hope to replicate these treatment effects of stimulants in a prospective, controlled manner. The investigators plan to measure ADHD symptom severity in patients before and after 12-weeks of controlled treatment with either a stimulant medication or placebo while utilizing structural and functional MRI. Combining imaging with a randomized controlled trial will allow us to better assess the effects of stimulants on brain function and structure.

Primary Outcome

Brain structure volume measured in mm\^3

Conditions Studied

Attention Deficit Hyperactivity Disorder

Interventions

  • DRUG Placebo
  • DRUG Lisdexamfetamine

Study Locations (1)

New York

  • New York State Psychiatric Institute - New York

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2011-08
Est. Completion 2018-06
Phase NA
New York State Psychiatric Institute

364 total trials

What the finished NCT01415440 record still lists

NCT01415440 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 215-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (46% lower).

The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01415440 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT01415440 about?

NCT01415440 is a clinical study titled "Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD". The aim of this study is to examine the mechanisms by which stimulant medications reduce symptoms in patients with Attention Deficit Hyperactivity Disorder (ADHD). Using Magnetic Resonance Imaging (MRI), the investigators have found that the volumes of certain brain regions are reduced in patients w...

What is the current status of trial NCT01415440?

This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 2011-08. Estimated completion is 2018-06.

What conditions does trial NCT01415440 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.

What interventions are being tested in trial NCT01415440?

The interventions under investigation include: Placebo (DRUG), Lisdexamfetamine (DRUG).

Who is sponsoring clinical trial NCT01415440?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01415440 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Attention Deficit Hyperactivity Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01415440's enrollment target sits among peer trials

117 42nd of 102 higher than 61 of 102 other Attention Deficit Hyperactivity Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder 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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Related registry views

Source: ClinicalTrials.gov NCT01415440, the US trial registry maintained by the National Library of Medicine. NCT01415440 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.