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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415440
• Other study ID #: 6235/7261R
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: June 2018

Study information

• Verified date: July 2022
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Lisdexamfetamine
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.
• Placebo
Placebo dosing will parallel that of Lisdexamfetamine.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Structure Volume	Brain structure volume measured in mm^3	12 weeks