Status:
COMPLETED
Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Shire
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to learn about the effects of a medication called Vyvanse on the heart (cardiovascular system). The U.S. Food and Drug Administration (FDA) has approved Vyvanse f...
Eligibility Criteria
Inclusion
- Male and female outpatients 18-60 years of age.
- A current DSM-IV-TR diagnosis of ADHD, confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) at Screening.
- In phase two only; Stage I primary hypertension (SBP 140-159 mm Hg/DBP 90-99 mm Hg) as defined by Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (Chobanian et al, 2003).
- In phase two only; Treatment with stable doses of up to two FDA approved antihypertensive medications achieving a stable blood pressure of \<135/85. Acceptable classes of medications include diuretics, beta-blockers, angiotensin-converting-enzyme (ACE) inhibitors or receptor blockers, aldosterone antagonists, calcium-channel blockers (Rosendorff et al, 2007).
Exclusion
- Pregnant or nursing females.
- Clinically significant cardiovascular history, including angina, syncope, thrombosis, aneurysm, myocardial infarction, myocarditis, valvular disease, heart failure, or arrhythmia. Hypertension is exclusionary in phase one subjects.
- In phase two; hypertension is not exclusionary, however blood pressure with antihypertensive treatment of ≥135/85 at baseline is exclusionary.
- Clinically significant or unstable medical condition including pulmonary (asthma, edema, thrombosis), renal, hepatic, metabolic (thyroid) or neurological disorder, based upon a medical history.
- Orthopedic impairment or BMI that significantly impacts or restricts exercise performance testing, per clinician judgment.
- Any clinically unstable psychiatric conditions including suicidality, homicidality, bipolar disorder, psychosis.
- Current (within 3 months) DSM-IV-TR criteria for current abuse or dependence with any psychoactive substance other than nicotine, including alcohol, prescription medicines and/or street drugs. In addition, subjects with clinically significant histories of dependence on alcohol, prescription medications or "street drugs" will be excluded, if such history places subjects at heightened risk, and/or may be associated with cardiovascular sequelae, based on clinician judgment.
- Ongoing treatment with any psychotropic medication, including anxiolytics, antidepressants, mood stabilizers.
- Use of Monoamine Oxidase Inhibitors (MAOIs) including linezolid within two weeks prior to starting study medication.
- Mental retardation (IQ \< 75).
- History of intolerance or allergy to LDX.
- Diagnosis of glaucoma
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00753012
Start Date
April 1 2008
End Date
March 1 2011
Last Update
September 24 2012
Active Locations (1)
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1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138