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ADHDPhase 4NCT01924429

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

A Phase 4 study testing Lisdexamfetamine in people with ADHD, run by Jeffrey Newcorn at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
ADHD
What is being tested?
Lisdexamfetamine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Mar 2013to Dec 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

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.

Conditions
ADHD
Being tested
Lisdexamfetamine
Keywords
Attention Deficit Hyperactivity Disorder, ADHD, fMRI, Imaging, Vyvanse, Stimulant Medication, Treatment, Clinical Trial, Adult
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LisdexamfetamineDrug

    Also called Vyvanse

    Escalating stepped dose titration: 30, 50 or 70mg

Study groups in NCT01924429
Study groupRoleWhat they receive
On Drug then off DrugExperimentalParticipants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg
Receives: Drug: Lisdexamfetamine
Off drug then on drugExperimentalParticipants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg
Receives: Drug: Lisdexamfetamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Go/No-Go Task Percentage Assessed by fMRI

    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.

    Measured: 8 weeks

  2. fMRI Reaction Time

    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

    Measured: up to 6 weeks

Secondary outcomes (11)

  1. BRIEF-A

    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)

    Measured: Baseline

  2. BRIEF-A

    Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)

    Measured: at one week

  3. BRIEF-A

    Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)

    Measured: at 4 weeks

  4. ASRS - Expanded

    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).

    Measured: Baseline

  5. ASRS - Expanded

    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).

    Measured: at one week

  6. ASRS - Expanded

    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).

    Measured: at 4 weeks

  7. WRAADS

    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.

    Measured: Baseline

  8. ADHD-RS-IV Combined Sum

    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.

    Measured: Baseline

  9. ADHD-Inattentive

    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.

    Measured: 4 weeks and 8 weeks

  10. CGI-I

    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).

    Measured: Baseline

  11. CGI-S

    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)

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01924429
Sponsor's protocol ID
GCO 09-1186
Status last verified
May 2018
First submitted
14 Aug 2013
Last updated
6 Jun 2018
Data monitoring committee
No

Publications

  • Newcorn JH, Ivanov I, Krone B, Li X, Duhoux S, White S, Schulz KP, Bedard AV, Pedraza J, Adler L, Blair RJ. Neurobiological basis of reinforcement-based decision making in adults with ADHD treated with lisdexamfetamine dimesylate: Preliminary findings and implications for mechanisms influencing clinical improvement. J Psychiatr Res. 2024 Feb;170:19-26. doi: 10.1016/j.jpsychires.2023.11.037. Epub 2023 Dec 3.

    PubMed 38101205

  • 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.

    PubMed 29661516

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lisdexamfetamine in people with ADHD, run by Jeffrey Newcorn at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Go/No-Go Task Percentage Assessed by fMRI (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01924429, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

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