Status:
COMPLETED
Effect of Vyvanse on Driving in Young Adults With ADHD
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Shire
Conditions:
Attention Deficit/Hyperactivity Disorder(ADHD)
Eligibility:
All Genders
18-24 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00801229
Start Date
December 1 2008
End Date
July 1 2010
Last Update
March 10 2014
Active Locations (1)
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1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138