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

NCT ID: NCT01924429

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-12-31

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

On Drug then off Drug

Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg

Group Type: EXPERIMENTAL

Lisdexamfetamine

Intervention Type: DRUG

Escalating stepped dose titration: 30, 50 or 70mg

Off drug then on drug

Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg

Group Type: EXPERIMENTAL

Lisdexamfetamine

Intervention Type: DRUG

Escalating stepped dose titration: 30, 50 or 70mg

Interventions

Lisdexamfetamine

Escalating stepped dose titration: 30, 50 or 70mg

Intervention Type: DRUG

Other Intervention Names

Vyvanse

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jeffrey Newcorn

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Newcorn

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeffrey Newcorn, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38101205 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29661516 (View on PubMed)

Other Identifiers

GCO 09-1186

Identifier Type: -

Identifier Source: org_study_id