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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

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 14, 2013
First Posted Date  ICMJE August 16, 2013
Results First Submitted Date  ICMJE March 27, 2017
Results First Posted Date  ICMJE June 6, 2018
Last Update Posted Date June 6, 2018
Study Start Date  ICMJE March 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
  • fMRI [ Time Frame: baseline ]
    2 fMRIs taken 4 weeks apart (pre-drug placebo period, maximum titrated dose, post-drug placebo period)
  • fMRI [ Time Frame: at 4 weeks ]
    2 fMRIs taken 4 weeks apart (pre-drug placebo period, maximum titrated dose, post-drug placebo period)
Change History Complete list of historical versions of study NCT01924429 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • 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)
  • 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)
  • 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)
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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).
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
  • BRIEF-A [ Time Frame: Baseline ]
    Assessment of executive functioning
  • BRIEF-A [ Time Frame: at one week ]
    Assessment of executive functioning off medication scan
  • BRIEF-A [ Time Frame: at 4 weeks ]
    Assessment of executive functioning medication scan
  • ASRS - Expanded [ Time Frame: Baseline ]
    ADHD symptoms self report
  • ASRS - Expanded [ Time Frame: at one week ]
    ADHD symptoms self report Off medication scan
  • ASRS - Expanded [ Time Frame: at 4 weeks ]
    ADHD symptoms self report medication scan
  • WRAADS [ Time Frame: Baseline ]
    Assessment of emotion regulation
  • WRAADS [ Time Frame: at one week ]
    Assessment of emotion regulation off medication scan
  • WRAADS [ Time Frame: at 4 weeks ]
    Assessment of emotion regulation medication scan
  • ADHD-RS [ Time Frame: Baseline ]
    ADHD symptoms and severity
  • ADHD-RS [ Time Frame: at one week ]
    ADHD symptoms and severity Off medication scan
  • ADHD-RS [ Time Frame: at 4 weeks ]
    ADHD symptoms and severity medication scan
  • CGI-I/CGI-S [ Time Frame: Baseline ]
    Symptom improvement/severity
  • CGI-I/CGI-S [ Time Frame: at one week ]
    Symptom improvement/severity Off medication scan
  • CGI-I/CGI-S [ Time Frame: at 4 weeks ]
    Symptom improvement/severity medication scan
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation
Official Title  ICMJE Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE ADHD
Intervention  ICMJE Drug: Lisdexamfetamine
Escalating stepped dose titration: 30, 50 or 70mg
Other Name: Vyvanse
Study Arms  ICMJE
  • Experimental: On Drug then off Drug
    Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg
    Intervention: Drug: Lisdexamfetamine
  • Experimental: Off drug then on drug
    Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg
    Intervention: Drug: Lisdexamfetamine
Publications * Schulz KP, Krone B, Adler LA, Bédard AV, Duhoux S, Pedraza J, Mahagabin S, Newcorn JH. Lisdexamfetamine Targets Amygdala Mechanisms That Bias Cognitive Control in Attention-Deficit/Hyperactivity Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Aug;3(8):686-693. doi: 10.1016/j.bpsc.2018.03.004. Epub 2018 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2013)
40
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01924429
Other Study ID Numbers  ICMJE GCO 09-1186
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey Newcorn, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Jeffrey Newcorn
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Newcorn, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP