AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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VYVANSE SUMMARY
Vyvanse™ (lisdexamfetamine dimesylate) C-II Rx Only
Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S)-1-methyl-2-phenylethyl]hexanamide dimethanesulfonate.
Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
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NEWS HIGHLIGHTS
Published Studies Related to Vyvanse (Lisdexamfetamine)
Health-related quality of life and functional outcomes from a
randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in
children and adolescents with attention-deficit/hyperactivity disorder. [2014] Scale-Parent Report (WFIRS-P), respectively... CONCLUSIONS: Using parent-rated instruments, long-term maintenance of the
A post hoc comparison of the effects of lisdexamfetamine dimesylate and
osmotic-release oral system methylphenidate on symptoms of attention-deficit
hyperactivity disorder in children and adolescents. [2013] methylphenidate (OROS-MPH) on symptoms of ADHD in children and adolescents... CONCLUSIONS: This post hoc analysis showed that, at the doses tested, patients
Lisdexamfetamine dimesylate improves processing speed and memory in cognitively
impaired MS patients: a phase II study. [2013] Multiple sclerosis (MS) causes cognitive impairment including slowed processing
speed and problems with learning and memory.These
preliminary data indicate that LDX has the potential to be an efficacious
treatment for MS patients with cognitive impairment.
Dose response effects of lisdexamfetamine dimesylate treatment in adults with
ADHD: an exploratory study. [2012] CONCLUSION: For LDX doses between 30 and 70 mg/d, the dose-response efficacy
Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis. [2011.11.04] ABSTRACT: BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral psychiatric disorder that afflicts children, with a reported prevalence of 2.4% to 19.8% worldwide. Stimulants (methylphenidate [MPH] and amphetamine) are considered first-line ADHD pharmacotherapy. MPH is a catecholamine reuptake inhibitor, whereas amphetamines have additional presynaptic activity. Although MPH and amphetamine can effectively manage ADHD symptoms in most pediatric patients, many still fail to respond optimally to either. After administration, the prodrug stimulant lisdexamfetamine dimesylate (LDX) is converted to l-lysine and therapeutically active d-amphetamine in the blood. The objective of this study was to evaluate the clinical efficacy of LDX in children with ADHD who remained symptomatic (ie, nonremitters; ADHD Rating Scale IV [ADHD-RS-IV] total score > 18) on MPH therapy prior to enrollment in a 4-week placebo-controlled LDX trial, compared with the overall population... CONCLUSION: In this analysis, children with significant clinical ADHD symptoms despite MPH treatment improved during treatment with LDX and experienced similar improvements in their symptoms as the overall study population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00556296.
Clinical Trials Related to Vyvanse (Lisdexamfetamine)
Effect of Vyvanse on Driving in Young Adults With ADHD [Completed]
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.
Effect of Vyvanse on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD) [Completed]
This study involves research to test how Vyvanse (study drug) affects sleep in 24 children
aged 6 to 12 years who have ADHD. Vyvanse is approved by the FDA for the treatment ADHD of
in children aged 6 to 12 years. The experimental part of this study is to determine how
Vyvanse affects sleep.
Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity [Terminated]
The purpose of this study to assess the effects of chronic administration of Vyvanse
(lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with
Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are
obese.
Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression [Terminated]
There have been reports that stimulants may be effective for bipolar depression without
triggering mania. This study will examine whether lisdexamfetamine can improve depressive
symptoms over the course of eight weeks. Lisdexamfetamine is a prodrug stimulant that is
currently approved for attention deficit hyperactivity disorder (ADHD). Participants take
the study drug or placebo in addition to a mood stabilizer. The study includes functional
magnetic resonance imaging and magnetic resonance spectroscopy to determine whether the
medication alters the response to affective stimuli or glutamate, glutamine, or gamma
aminobutyric acid (GABA) levels. Neuropsychological testing is also included to determine
whether the study drug improves memory and attention in this population. The primary
hypothesis is that lisdexamfetamine is clinically effective in this population. The
secondary hypothesis is that it will result in an increased response to affective stimuli
and altered neurotransmitter levels in the anterior cingulate cortex.
Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults [Completed]
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 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
People who have ADHD have trouble paying attention, organizing, and planning; these symptoms
can cause problems at work, socially and at home.
Vyvanse (also known as Lisdexamfetamine) is a stimulant class medication. There have been
reports of serious cardiovascular effects in children and adults treated with stimulants.
While there is no definite evidence that these events were related to the use of stimulants,
the deaths have raised questions about the cardiovascular safety of stimulants.
The study will involve in-depth cardiovascular tests, namely echocardiograph (ultrasound of
the heart) and cardiopulmonary exercise test (also called stress test; subjects exercise on
a bicycle while measuring their heart activity and breathing is monitored by cardiologists).
The investigators predict to see changes in blood pressure and heart rate as shown in
previous clinical studies, and that the in-depth cardiovascular tests will provide new
insights into the cardiovascular impact of stimulants.
Reports of Suspected Vyvanse (Lisdexamfetamine) Side Effects
Depression (29),
Suicidal Ideation (26),
Aggression (21),
Product Quality Issue (19),
Drug Effect Decreased (18),
Drug Ineffective (17),
Overdose (16),
Psychotic Disorder (15),
Anger (14),
Condition Aggravated (14), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 28 ratings/reviews, Vyvanse has an overall score of 8.25. The effectiveness score is 9.21 and the side effect score is 7.07. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| Vyvanse review by 44 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | Mild Side Effects | | Treatment Info |
Condition / reason: | | ADD |
Dosage & duration: | | 70 miligrams (dosage frequency: 1 daily) for the period of 4 months |
Other conditions: | | none |
Other drugs taken: | | wellbutrin | | Reported Results |
Benefits: | | Helps with concentration and staying focused. Helps to keep me from being hyperactive and fidgety and helps with memory to an extent. |
Side effects: | | If I am stressed, I seem to be jittery and the benefits are not as prominent. |
Comments: | | I was diagnosed with ADD three years ago. Have tried several different prescriptions and found the best results from Adderall and Vyvanse. |
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| Vyvanse review by 18 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | Mild Side Effects | | Treatment Info |
Condition / reason: | | ADD |
Dosage & duration: | | 30mg taken once in the morning for the period of 4 months |
Other conditions: | | daydreaming and underperforming socially and accedemically |
Other drugs taken: | | N/A | | Reported Results |
Benefits: | | My mood has noticably improved, I have more energy, experience better sleep and digestion. |
Side effects: | | a few experiences of nausiea, heavy moodswings on the days I do not take it, decreased appetite, and some negative affect on my short-term memory. |
Comments: | | I had began taking 20mg of Vyvanse for three months and was surprised to find that such a small dose affected my mood so effectively. When it came to school work though I found that I needed the 30mg to increase my level of focus (and have been on it for a month since). I had not experienced decreased appetite until about a month into taking the 20mg. I find that the greatest benefit of Vyvanse for me is that it tends to stabalize my mood on a daily basis and lessens any bouts of anxiety and depression that i used to face before I was perscribed. |
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| Vyvanse review by 37 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Ineffective |
Side effects: | | Moderate Side Effects | | Treatment Info |
Condition / reason: | | add |
Dosage & duration: | | 30mg taken daily for the period of 2 weeks |
Other conditions: | | na |
Other drugs taken: | | na | | Reported Results |
Benefits: | | Slight eurphoria and "high" felt good but not what I was trying to treat |
Side effects: | | aggravated acne, short term memory loss, loss of cognitive abilities |
Comments: | | Most recently diagnosed with adult add, never tried add medications before. Tried to give it time to work as many people say side effects get better but could not deal with the major facial skin breakouts. |
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Page last updated: 2015-08-10
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