CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 117 enrolled
Drug / intervention
Lisdexamfetamine +1 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/NCT01415440
NCT01415440N/ACompleted

Examining the Effects of Stimulant Medication on Emotional Lability in Patients With Attention Deficit Hyperactivity Disorder (ADHD)

New York State Psychiatric Institute·interventional·Posted Aug 12, 2011·Updated Aug 2, 2022

In Brief

A clinical study evaluating Lisdexamfetamine and Placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 117 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 12, 2011
Enrollment StartAug 1, 2011
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 14.9 years ago

Interventions

Lisdexamfetaminedrug

During the first 4 weeks of treatment, the dosage of Lisdexamfetamine will be adjusted based on the patient's response to the medication. The patient will then be maintained at the lowest effective dose for the remaining 8 weeks of treatment.

Placebodrug

Placebo dosing will parallel that of Lisdexamfetamine.