Attention Deficit/Hyperactivity Disorder(ADHD)Phase 4NCT00801229
Effect of Vyvanse on Driving in Young Adults With ADHD
A Phase 4 study testing Vyvanse in people with Attention Deficit/Hyperactivity Disorder(ADHD), run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder(ADHD)
- What is being tested?
- Vyvanse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jul 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: The Effects of Vyvanse on the Driving Performance of Young Adults With ADHD: A Randomized, Double-Blind, Placebo-Controlled Study
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.
- Being tested
- Vyvanse, Placebo
- Keywords
- ADHD, young adults, driving, Vyvanse, lisdexamfetamine
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VyvanseDrug
Also called Lisdexamfetamine
Vyvanse 30, 50, or 70 mg daily
PlaceboDrug
Placebo 30, 50, 70 mg daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit/Hyperactivity Disorder(ADHD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Joseph Biederman, MD, Massachusetts General Hospital
- Investigators
- Joseph Biederman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801229
- Sponsor's protocol ID
- 2008P000971
- Status last verified
- Feb 2014
- First submitted
- 2 Dec 2008
- Last updated
- 10 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23174471
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vyvanse on the Driving Performance of Young Adults With ADHD: A Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00801229
- Acronym / sponsor ID
- 2008P000971
- Keywords
- ADHD, young adults, driving, Vyvanse, lisdexamfetamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Dec 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Posted 25 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vyvanse | Active comparator | Drug: VyvansePatients may be randomized to the active comparator arm. Participants randomized to this arm will receive 30, 50, or 70mg Vyvanse daily. |
| Placebo | Placebo comparator | Drug: PlaceboPatients may be randomized to the placebo comparator arm. Those randomized to this arm will receive 30, 50, or 70mg placebo daily. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VyvanseAlso: LisdexamfetamineVyvanse 30, 50, or 70 mg daily | Drug | Vyvanse |
| PlaceboPlacebo 30, 50, 70 mg daily | Drug | Placebo |
Primary outcome
Participants Experiencing Collisions During "Surprise Events" in Driving Simulator
Time frame: 6 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23174471Biederman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Biederman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vyvanse in people with Attention Deficit/Hyperactivity Disorder(ADHD), run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Experiencing Collisions During "Surprise Events" in Driving Simulator (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2014.