Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Jeffrey Newcorn, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01924429
First received: August 14, 2013
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine the effects of Vyvanse, an FDA approved medication used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), on brain activity in adults with attention-deficit hyperactivity disorder (ADHD). Participants may qualify for participation in this study because they have ADHD and are willing to participate in two Functional Magnetic Resonance Imaging (fMRI) scans and receive Vyvanse for treatment of their symptoms. Another purpose of this study is to collect and bank samples of blood for research to examine how genes influence brain activation seen during the brain scans. The study also seeks to find out whether certain genes are related to ADHD. Participants' entire genetic makeup will not be determined from this sample.


Condition Intervention Phase
ADHD
Drug: Lisdexamphetamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • fMRI [ Time Frame: baseline ] [ Designated as safety issue: No ]
    2 fMRIs taken 4 weeks apart (pre-drug placebo period, maximum titrated dose, post-drug placebo period)

  • fMRI [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
    2 fMRIs taken 4 weeks apart (pre-drug placebo period, maximum titrated dose, post-drug placebo period)


Secondary Outcome Measures:
  • BRIEF-A [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessment of executive functioning

  • BRIEF-A [ Time Frame: at one week ] [ Designated as safety issue: No ]
    Assessment of executive functioning off medication scan

  • BRIEF-A [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
    Assessment of executive functioning medication scan

  • ASRS - expanded [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    ADHD symptoms self report

  • ASRS - expanded [ Time Frame: at one week ] [ Designated as safety issue: No ]
    ADHD symptoms self report Off medication scan

  • ASRS - expanded [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
    ADHD symptoms self report medication scan

  • WRAADS [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessment of emotion regulation

  • WRAADS [ Time Frame: at one week ] [ Designated as safety issue: No ]
    Assessment of emotion regulation off medication scan

  • WRAADS [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
    Assessment of emotion regulation medication scan

  • ADHD-RS [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    ADHD symptoms and severity

  • ADHD-RS [ Time Frame: at one week ] [ Designated as safety issue: No ]
    ADHD symptoms and severity Off medication scan

  • ADHD-RS [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
    ADHD symptoms and severity medication scan

  • CGI-I/CGI-S [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Symptom improvement/severity

  • CGI-I/CGI-S [ Time Frame: at one week ] [ Designated as safety issue: No ]
    Symptom improvement/severity Off medication scan

  • CGI-I/CGI-S [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
    Symptom improvement/severity medication scan


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: On Drug then off Drug
Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg
Drug: Lisdexamphetamine
Escalating stepped dose titration: 30, 50 or 70mg
Other Name: Vyvanse
Experimental: Off drug then on drug
Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg
Drug: Lisdexamphetamine
Escalating stepped dose titration: 30, 50 or 70mg
Other Name: Vyvanse

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary DSM-IV-TR diagnosis of adult ADHD (inattentive, hyperactive-impulsive or combined subtype), established via the ACDS v1.2.
  • Must be between 18-55 years, inclusive.
  • Provides written informed consent.

Exclusion Criteria:

  • Lifetime or current diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder.
  • Current diagnosis of comorbid major depressive disorder, anxiety disorder or dysthymia or any controlled (i.e. requires pharmacological treatment) comorbid diagnosis. Participants with uncontrolled depressive or anxiety disorders may participate if, in the opinion of the Principal Investigator, the disorder will not confound the results of efficacy or safety assessments, increase risk to the participant or lead to difficulty complying with the protocol.
  • Meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or dependence disorder.
  • Have organic brain disease (such as dementia) or traumatic brain injury residua. Have a history of seizure disorder (other than febrile seizures) or participants who have taken (or are currently taking) anticonvulsants for seizure control.
  • Females who are currently pregnant or breast feeding, and women of child-bearing potential who are not currently using an adequate form of birth control.
  • Participants with clinically significant abnormalities in ECG results that are deemed exclusionary in the opinion of the Principal Investigator will not be allowed in the trial.
  • Participants who work the night shift or another schedule that would preclude beginning the daily dose of study medication in the morning.
  • Participants with a positive urine drug result at Screening.
  • Medical conditions limiting participation in the study.
  • Documented history of intolerance or non-responsivity to methylphenidate or amphetamines.
  • Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous.
  • ADHD, Not Otherwise Specified
  • History of surgery involving metal implants, metal fragments in the eyes, braces, or a pacemaker.
  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: NCT01924429

Contacts
Contact: Beth Krone, PhD 212-241-8012 beth.krone@mssm.edu
Contact: Jeffrey Newcorn, MD 212-659-8705 jeffrey.newcorn@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Beth Krone, Ph.D.    212-241-8012    beth.krone@mssm.edu   
Contact: Stephanie Duhoux, Ph.D.    212-241-7009    stephanie.duhoux@mssm.edu   
Principal Investigator: Jeffrey Newcorn, MD         
Sponsors and Collaborators
Jeffrey Newcorn
Investigators
Principal Investigator: Jeffrey Newcorn, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Jeffrey Newcorn, Associate Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01924429     History of Changes
Other Study ID Numbers: GCO 09-1186
Study First Received: August 14, 2013
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by Mount Sinai School of Medicine:
Attention Deficit Hyperactivity Disorder
ADHD
fMRI
Imaging
Vyvanse
Stimulant Medication
Treatment
Clinical Trial
Adult

ClinicalTrials.gov processed this record on October 23, 2014