Clinical trial NCT01924429: Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation
Official title: Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ADHD
Keywords: Attention Deficit Hyperactivity Disorder
ADHD
fMRI
Imaging
Vyvanse
Stimulant Medication
Treatment
Clinical Trial
Adult
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: The Go/No-Go Task Percentage Assessed by fMRI
timeFrame: 8 weeks
measure: fMRI Reaction Time
timeFrame: up to 6 weeks
Secondary outcomes:
measure: BRIEF-A
timeFrame: Baseline
measure: BRIEF-A
timeFrame: at one week
measure: BRIEF-A
timeFrame: at 4 weeks
measure: ASRS - Expanded
timeFrame: Baseline
measure: ASRS - Expanded
timeFrame: at one week
measure: ASRS - Expanded
timeFrame: at 4 weeks
measure: WRAADS
timeFrame: Baseline
measure: ADHD-RS-IV Combined Sum
timeFrame: Baseline
measure: ADHD-Inattentive
timeFrame: 4 weeks and 8 weeks
measure: CGI-I
timeFrame: Baseline
measure: CGI-S
timeFrame: baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jeffrey Newcorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schulz KP, Krone B, Adler LA, Bedard 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.