Vyvanse Driving Study - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Shire Pharmaceutical Development
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00801229

Purpose

The primary objective of the study is to assess the benefice of Vyvanse on the factors that cause impairments in driving behavior in individuals with ADHD using a driving simulation aimed at examining the factors that cause impairments in driving behavior in individuals with ADHD such as driving speed, collision risk, and visual attention of 60 young drivers (ages 18-24) with ADHD. We hypothesize: 1.) young adults with ADHD treated with Vyvanse will show lower velocity (speed) scores and spend less time driving over the posted speed limit in the driving simulation when compared to subjects taking a placebo; 2.) young adults with ADHD treated with Vyvanse will show a lesser likelihood to collide with a suddenly appearing peripheral object, less difficulty maintaining the vehicle within their lane, and a lesser likelihood of driving through stop signs and solid red traffic lights without slowing down when compared to subjects taking a placebo; and 3.) young adults with ADHD treated with Vyvanse will exhibit more focused visual attention on details in the visual field when compared to subjects taking a placebo while driving. In addition, young adults with ADHD treated with Vyvanse will exhibit less visual tunneling and shorter off-road glances when compared to subjects taking a placebo.

Condition	Intervention	Phase
Attention Deficit/Hyperactivity Disorder(ADHD)	Drug: Vyvanse (lisdexamfetamine) or placebo	Phase IV

Drug Information available for: Lisdexamfetamine Lisdexamfetamine dimesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effects of Vyvanse on the Driving Performance of Young Adults With ADHD: A Randomized, Double-Blind, Placebo-Controlled Study

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vyvanse: Active Comparator	Drug: Vyvanse (lisdexamfetamine) or placebo Vyvanse 30, 50, or 70 mg daily
Placebo: Placebo Comparator	Drug: Vyvanse (lisdexamfetamine) or placebo Placebo 30, 50, 70 mg daily

Eligibility

Ages Eligible for Study:	18 Years to 24 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female outpatients, aged 18-24 years.
Subjects meeting full criteria for the diagnosis of DSM-IV Attention Deficit Hyperactivity Disorder (ADHD), with onset of symptoms in childhood and persistence of impairing symptoms into adulthood as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician.
Absence of pharmacological treatment for ADHD for the past month.

Exclusion Criteria:

Any other current psychiatric or medical condition determined to be clinically significant.
Current use of psychotropics or any medication with clinically significant CNS effects.
Individuals who have never held a valid driver's license.
Mental retardation (IQ < 80).
Individuals with a history of substance dependence or abuse within the past 6 months. Pregnant or nursing females.
Known hypersensitivity to Vyvanse or amphetamines.
Subjects with pre-existing structural cardiac abnormalities.
Clinically significant abnormal screening values including:
Laboratory values determined to be clinically significant.
Consistent readings of hypertension (>140/90) during screening period (including screening and baseline visits), defined as two or more readings (each being the average of three measurements) at a single visit with systolic blood pressure, SBP > 140 and/or diastolic blood pressure, DBP, > 90, and confirmed by manual reading.
Subjects with isolated incidences (of triplicate average BP) of SBP > 140 and/or DBP > 90 at baseline/week 0 visit, confirmed by manual reading, which are determined to be clinically significant. Subjects with a clinically significant abnormality according to cardiology consultation (ECGs with clinically concerning intervals including PR, QTC, QRS, will be reviewed by cardiology).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801229

Contacts

Contact: Meghan Kotarski, MBA	617-503-1051	mkotarski@partners.org
Contact: Courtney Williams, BA	617-503-1089	cgwilliams@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Cambridge, Massachusetts, United States, 02138
Principal Investigator: Janet Wozniak, MD

Sponsors and Collaborators

Massachusetts General Hospital

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Janet Wozniak, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Janet Wozniak, MD )
Study ID Numbers:	2008P000971
Study First Received:	December 2, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00801229 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

ADHD
young adults
driving
Vyvanse
lisdexamfetamine

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Dyskinesias
Signs and Symptoms
Dopamine

Attention Deficit Disorder with Hyperactivity
Mental Disorders
Dextroamphetamine
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Dyskinesias
Pharmacologic Actions

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Dextroamphetamine
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009