Effect of Vyvanse on Driving in Young Adults With ADHD

NCT00801229 | Completed Phase 4 Results

• 1 other identifier: 2008P000971
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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)

Keywords

ADHD; young adults; driving; Vyvanse; lisdexamfetamine

Outcome Measures

Primary Outcomes (1)

• Participants Experiencing Collisions During "Surprise Events" in Driving Simulator

  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. During the simulation, "surprise events," designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo.

  6 weeks

Study Arms (2)

Vyvanse

ACTIVE COMPARATOR

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

Drug: Vyvanse

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Vyvanse DRUG

Vyvanse 30, 50, or 70 mg daily

Also known as: Lisdexamfetamine

Vyvanse

Placebo DRUG

Placebo 30, 50, 70 mg daily

Placebo

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Shire: collaborator

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

• 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.

  PMID: 23174471 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Joseph Biderman, MD
• Organization: Massachusetts General Hospital

617-726-1746

Study Officials

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 10, 2014
• Results First Posted: August 25, 2011

Record last verified: 2014-02

Locations

US (1)