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Trial record 14 of 111 for:    nrp 104 OR lisdexamfetamine

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 : Completed
First Posted : August 16, 2013
Results First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey Newcorn, Icahn School of Medicine at Mount Sinai

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: Lisdexamfetamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 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
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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: Lisdexamfetamine
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: Lisdexamfetamine
Escalating stepped dose titration: 30, 50 or 70mg
Other Name: Vyvanse




Primary Outcome Measures :
  1. The Go/No-Go Task Percentage Assessed by fMRI [ Time Frame: 8 weeks ]
    Performance Measures on the Go/No-Go Task assessed by fMRI as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder. The Go/No-Go Task is a neuropsychological test that provides a direct measure of number of responses made that are "correct" or "incorrect". It is not a scale. Reported are the percentage of correct responses on that direct performance measure. 0% correct is worse than 100% correct.

  2. fMRI Reaction Time [ Time Frame: up to 6 weeks ]
    Reaction-time, as measured by the reaction time test Go/No-Go Task as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder


Secondary Outcome Measures :
  1. BRIEF-A [ Time Frame: Baseline ]
    Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (0 to 100, with 50 +/-1 SD = 'Normal', higher is worse, more impaired)

  2. BRIEF-A [ Time Frame: at one week ]
    Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)

  3. BRIEF-A [ Time Frame: at 4 weeks ]
    Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)

  4. ASRS - Expanded [ Time Frame: Baseline ]
    ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and >27 (clinically significant symptoms).

  5. ASRS - Expanded [ Time Frame: at one week ]
    ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and >27 (clinically significant symptoms).

  6. ASRS - Expanded [ Time Frame: at 4 weeks ]
    ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and >27 (clinically significant symptoms).

  7. WRAADS [ Time Frame: Baseline ]

    The Wender-Reimherr adult attention deficit disorder scale (WRAADS): Symptom measure for emotional functioning/lability, generally reported as Sum of Responses (0-2 per item, higher = more impaired).

    For this outcome measure, Average scores for particular questions were taken - specifically question 3, question 4, and question 5.


  8. ADHD-RS-IV Combined Sum [ Time Frame: Baseline ]
    ADHD symptoms and severity. Norm referenced interview to assess severity and frequency of ADHD symptoms. 18 Items are scored 0-3 to reflect severity and frequency of ADHD symptoms, and a sum is taken. Full range from 0 to 54, with higher number indicating more symptoms and severity.

  9. ADHD-Inattentive [ Time Frame: 4 weeks and 8 weeks ]
    ADHD symptoms and severity - subscale for Inattentiveness. 9-item scale, each scored 0-3, with total from 0 to 27. Higher score indicates higher level of inattentiveness.

  10. CGI-I [ Time Frame: Baseline ]
    Clinical Global Impressions - CGI-I: Clinical response was the Clinical Global Impression-Improvement scale (CGI-I). Lower CGI-I scores indicate greater improvement (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).

  11. CGI-S [ Time Frame: baseline ]
    CGI-S: Severity of impairment due to ADHD was measured by the Clinical Global Impressions-Severity scale (CGI-S). Lower scores indicate less severe impairment from symptoms, with a CGI-I=1 indicating the person is "normal" with no impairment. (1= normal, not ill, 2= minimally ill, 3= mildly ill, 4= moderately ill, 5=markedly ill, 6=severely ill, 7= very severely ill)



Information from the National Library of Medicine

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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


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Jeffrey Newcorn
Investigators
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Principal Investigator: Jeffrey Newcorn, MD Icahn School of Medicine at Mount Sinai

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeffrey Newcorn, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01924429     History of Changes
Other Study ID Numbers: GCO 09-1186
First Posted: August 16, 2013    Key Record Dates
Results First Posted: June 6, 2018
Last Update Posted: June 6, 2018
Last Verified: May 2018
Keywords provided by Jeffrey Newcorn, Icahn School of Medicine at Mount Sinai:
Attention Deficit Hyperactivity Disorder
ADHD
fMRI
Imaging
Vyvanse
Stimulant Medication
Treatment
Clinical Trial
Adult
Additional relevant MeSH terms:
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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