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NCT02259517 · ClinicalTrials.gov registry record · NA

An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD

A NA study, sponsored by New York State Psychiatric Institute.

Terminated
Registry status
NA
Development phase
38
Enrollment target

NCT02259517: Clinical Trial NA study, sponsored by New York State Psychiatric Institute.

NCT02259517 is a NA study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02259517, a NA study, was terminated before completion, sponsored by New York State Psychiatric Institute.

TERMINATED
Registry status
NA
Development phase
38 participants
Enrollment target

Study Summary

Children with Attention-Deficit/Hyperactivity Disorder (ADHD) are typically treated with two types of medications with differing mechanisms of action: stimulants and non-stimulants. The stimulant Vyvanse (lisdexamfetamine, LDX), and the non-stimulant Intuniv (extended-release guanfacine, GXR), are both FDA approved treatment for ADHD. Clinical trials have shown that both medications are effective in reducing ADHD symptoms, although the neurobiological mechanisms by which Vyvanse and Intuniv produce these effects remain unknown. The aim of this study is to examine the mechanisms by which LDX and GXR reduce symptoms in patients with ADHD. MRI scanning will be used to identify treatment-related changes in brain structure and function.

Primary Outcome

Brain segmentation volume measured in mm\^3. We are reporting the mean difference in brain segmentation volume from baseline (pre-test) to 6 weeks (post-test). No statistical analysis information is being submitted for the affected outcome measure. No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollment. Enrollment terminated early as a result of the COVID-19 pandemic.

Interventions

  • DRUG Guanfacine
  • DRUG Lisdexamfetamine

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2014-09
Est. Completion 2021-11-06
Phase NA

Why NCT02259517 stopped before completion

NCT02259517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Guanfacine is the first listed.

NCT02259517 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02259517 about?

NCT02259517 is a clinical study titled "An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD". Children with Attention-Deficit/Hyperactivity Disorder (ADHD) are typically treated with two types of medications with differing mechanisms of action: stimulants and non-stimulants. The stimulant Vyvanse (lisdexamfetamine, LDX), and the non-stimulant Intuniv (extended-release guanfacine, GXR), are b...

What is the current status of trial NCT02259517?

This trial is currently terminated. It is a NA study. The enrollment target is 38 participants. The study started on 2014-09. Estimated completion is 2021-11-06.

What interventions are being tested in trial NCT02259517?

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

Who is sponsoring clinical trial NCT02259517?

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

How this trial's enrollment target compares

Where NCT02259517's enrollment target sits among peer trials

38 1538th of 2000 higher than 461 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT02259517, the US trial registry maintained by the National Library of Medicine. NCT02259517 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.