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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01415440
Recruitment Status : Recruiting
First Posted : August 12, 2011
Last Update Posted : April 2, 2018
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Lisdexamfetamine Drug: Placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining the Effects of Stimulant Medication on Emotional Lability in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : July 2011
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Sugar pill

Primary Outcome Measures :
  1. Changes in brain structure and function produced by stimulant medications in patients with ADHD [ Time Frame: 12 weeks ]
    This will be assessed using MRI, diagnostic interviews, behavior rating scales, and computer tasks.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01415440

Contact: Jonathan Posner, M.D 646-774-5735

United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Jonathan Posner, MD    646-774-5735   
Principal Investigator: Jonathan Posner, MD         
Sub-Investigator: Laurence Greenhill, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
Principal Investigator: Jonathan Posner, M.D NYSPI

Responsible Party: New York State Psychiatric Institute Identifier: NCT01415440     History of Changes
Other Study ID Numbers: 6235/7261R
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by New York State Psychiatric Institute:
stimulant medication

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Lisdexamfetamine Dimesylate
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents