Effect of Vyvanse on Driving in Young Adults With ADHD

NCT ID: NCT00801229

Last Updated: 2014-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-07-31

Brief Summary

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.

Conditions

Attention Deficit/Hyperactivity Disorder(ADHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vyvanse

Patients may be randomized to the active comparator arm. Participants randomized to this arm will receive 30, 50, or 70mg Vyvanse daily.

Group Type: ACTIVE_COMPARATOR

Vyvanse

Intervention Type: DRUG

Vyvanse 30, 50, or 70 mg daily

Placebo

Patients may be randomized to the placebo comparator arm. Those randomized to this arm will receive 30, 50, or 70mg placebo daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 30, 50, 70 mg daily

Interventions

Vyvanse

Vyvanse 30, 50, or 70 mg daily

Intervention Type: DRUG

Placebo

Placebo 30, 50, 70 mg daily

Intervention Type: DRUG

Other Intervention Names

Lisdexamfetamine

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph Biederman, MD

Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Biederman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Cambridge, Massachusetts, United States

Countries

United States

References

Biederman J, Fried R, Hammerness P, Surman C, Mehler B, Petty CR, Faraone SV, Miller C, Bourgeois M, Meller B, Godfrey KM, Baer L, Reimer B. The effects of lisdexamfetamine dimesylate on driving behaviors in young adults with ADHD assessed with the Manchester driving behavior questionnaire. J Adolesc Health. 2012 Dec;51(6):601-7. doi: 10.1016/j.jadohealth.2012.03.005. Epub 2012 Apr 20.

Reference Type: DERIVED

PMID: 23174471 (View on PubMed)

Other Identifiers

2008P000971

Identifier Type: -

Identifier Source: org_study_id