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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01415440
First received: July 26, 2011
Last updated: May 19, 2016
Last verified: May 2016
  Purpose

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 Intervention
Attention Deficit Hyperactivity Disorder
Drug: Lisdexamfetamine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Changes in brain structure and function produced by stimulant medications in patients with ADHD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This will be assessed using MRI, diagnostic interviews, behavior rating scales, and computer tasks.


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415440

Contacts
Contact: Jonathan Posner, M.D 646-774-5735 posnerj@nyspi.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Jonathan Posner, MD    646-774-5735    posnerj@nyspi.columbia.edu   
Principal Investigator: Jonathan Posner, MD         
Sub-Investigator: Laurence Greenhill, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
Shire
Investigators
Principal Investigator: Jonathan Posner, M.D NYSPI
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01415440     History of Changes
Other Study ID Numbers: 6235/7261R 
Study First Received: July 26, 2011
Last Updated: May 19, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by New York State Psychiatric Institute:
ADHD
Vyvanse
stimulant medication
ADD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
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

ClinicalTrials.gov processed this record on August 25, 2016