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

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ClinicalTrials.gov Identifier: NCT01924429
Recruitment Status : Unknown
Verified August 2013 by Jeffrey Newcorn, Mount Sinai School of Medicine.
Recruitment status was:  Recruiting
First Posted : August 16, 2013
Last Update Posted : August 16, 2013
Sponsor:
Information provided by (Responsible Party):
Jeffrey Newcorn, Mount Sinai School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
ADHD Drug: Lisdexamphetamine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation
Study Start Date : March 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. fMRI [ Time Frame: baseline ]
    2 fMRIs taken 4 weeks apart (pre-drug placebo period, maximum titrated dose, post-drug placebo period)

  2. fMRI [ Time Frame: at 4 weeks ]
    2 fMRIs taken 4 weeks apart (pre-drug placebo period, maximum titrated dose, post-drug placebo period)


Secondary Outcome Measures :
  1. BRIEF-A [ Time Frame: Baseline ]
    Assessment of executive functioning

  2. BRIEF-A [ Time Frame: at one week ]
    Assessment of executive functioning off medication scan

  3. BRIEF-A [ Time Frame: at 4 weeks ]
    Assessment of executive functioning medication scan

  4. ASRS - expanded [ Time Frame: Baseline ]
    ADHD symptoms self report

  5. ASRS - expanded [ Time Frame: at one week ]
    ADHD symptoms self report Off medication scan

  6. ASRS - expanded [ Time Frame: at 4 weeks ]
    ADHD symptoms self report medication scan

  7. WRAADS [ Time Frame: Baseline ]
    Assessment of emotion regulation

  8. WRAADS [ Time Frame: at one week ]
    Assessment of emotion regulation off medication scan

  9. WRAADS [ Time Frame: at 4 weeks ]
    Assessment of emotion regulation medication scan

  10. ADHD-RS [ Time Frame: Baseline ]
    ADHD symptoms and severity

  11. ADHD-RS [ Time Frame: at one week ]
    ADHD symptoms and severity Off medication scan

  12. ADHD-RS [ Time Frame: at 4 weeks ]
    ADHD symptoms and severity medication scan

  13. CGI-I/CGI-S [ Time Frame: Baseline ]
    Symptom improvement/severity

  14. CGI-I/CGI-S [ Time Frame: at one week ]
    Symptom improvement/severity Off medication scan

  15. CGI-I/CGI-S [ Time Frame: at 4 weeks ]
    Symptom improvement/severity medication scan



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): 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 Icahn School of Medicine at Mount Sinai

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
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: August 16, 2013
Last Verified: August 2013

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

Additional relevant MeSH terms:
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents