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

July 29, 2022 updated by: Jonathan Posner, New York State Psychiatric Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychostimulant
30-70 mg capsule of Lisdexamfetamine once daily for 12 weeks
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.
Other Names:
  • Vyvanse
Placebo Comparator: Placebo
30-70 mg capsule of placebo (sugar pill) once daily for 12 weeks
Drug: Placebo
Placebo dosing will parallel that of Lisdexamfetamine.
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Structure Volume
Time Frame: 12 weeks
Brain structure volume measured in mm^3
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

Shire

Investigators

  • Principal Investigator: Jonathan Posner, M.D, NYSPI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (Estimate)

August 12, 2011

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6235/7261R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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