Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 25 |
| Updated: | 10/13/2018 |
| Start Date: | August 2011 |
| End Date: | June 2018 |
Examining the Effects of Stimulant Medication on Emotional Lability in Patients With Attention Deficit Hyperactivity Disorder (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 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.
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.
A cohort of 100 patients with ADHD will be recruited for a 12 week, double-blind, parallel,
randomized controlled trial of Lisdexamfetamine (Vyvanse) versus placebo, with 50 patients
randomized to Lisdexamfetamine and the other 50 patients to placebo. The investigators will
acquire high-resolution, anatomical and functional MRI images at baseline and after 12 weeks
of treatment.
In addition, 75 age- and sex-matched healthy control subjects will be imaged at baseline.
randomized controlled trial of Lisdexamfetamine (Vyvanse) versus placebo, with 50 patients
randomized to Lisdexamfetamine and the other 50 patients to placebo. The investigators will
acquire high-resolution, anatomical and functional MRI images at baseline and after 12 weeks
of treatment.
In addition, 75 age- and sex-matched healthy control subjects will be imaged at baseline.
Inclusion Criteria:
ADHD Participants: Meets Diagnostic and Statistical Manual of Mental Disorders, 4th
Edition, Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD, any subtype.
Healthy Control Participants: No current DSM-IV-TR Axis I psychiatric diagnosis.
All Participants:
1. Male or female, 6 - 25 years of age, and in good physical health
2. English-speaking
Exclusion Criteria:
1. Current comorbid DSM-IV-TR Axis I psychiatric diagnosis or other symptomatic
manifestations that, in the opinion of the examining physician, will contraindicate
Lisdexamfetamine treatment or confound safety assessments
2. Meets DSM-IV-TR criteria for active substance abuse and/or dependence
3. Lifetime history of cocaine or stimulant abuse or dependence
4. Actively suicidal
5. Children and adolescents: Prior treatment with psychostimulants for longer than 1
month duration and/or treatment with psychostimulants within the past 4 months Adults:
Treatment with psychostimulants within the past 12 months.
6. Documented allergy or intolerance to Lisdexamfetamine or other stimulant medications.
7. Taking other medications with central nervous system effects.
8. History of seizure (other than febrile seizure)
9. Diagnosis of hyperthyroidism, glaucoma, or other serious medical illness.
10. Personal or family history of medical conditions, such as cardiovascular disease, that
may interfere with study participation, or for which treatment with Lisdexamfetamine
may pose a risk
11. Pregnant or lactating
12. MRI contraindications such as pacemaker, braces, etc.
13. Full scale intelligence quotient (FSIQ) less than 70
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Principal Investigator: Jonathan Posner, MD
Phone: 646-774-5735
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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