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Effect of Vyvanse on Driving in Young Adults With ADHD

Primary Purpose

Attention Deficit/Hyperactivity Disorder(ADHD)

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vyvanse

Placebo

About this trial

This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder(ADHD) focused on measuring ADHD, young adults, driving, Vyvanse, lisdexamfetamine

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vyvanse

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00801229

First Posted

December 2, 2008

Last Updated

February 5, 2014

Sponsor

Massachusetts General Hospital

Collaborators

Shire

1. Study Identification

Unique Protocol Identification Number

NCT00801229

Brief Title

Effect of Vyvanse on Driving in Young Adults With ADHD

Official Title

The Effects of Vyvanse on the Driving Performance of Young Adults With ADHD: A Randomized, Double-Blind, Placebo-Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Shire

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit/Hyperactivity Disorder(ADHD)

Keywords

ADHD, young adults, driving, Vyvanse, lisdexamfetamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vyvanse

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vyvanse

Other Intervention Name(s)

Lisdexamfetamine

Intervention Description

Vyvanse 30, 50, or 70 mg daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo 30, 50, 70 mg daily

Primary Outcome Measure Information:

Title

Participants Experiencing Collisions During "Surprise Events" in Driving Simulator

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Biederman, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02138

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23174471

Citation

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.

Results Reference

derived

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Effect of Vyvanse on Driving in Young Adults With ADHD

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