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STUDY RESULTS

See clinical study results in adults with ADHD

Learn more about Vyvanse and take a look at how it performed in clinical studies.

Vyvanse clinical study results

Vyvanse may help increase attention, and decrease impulsiveness and hyperactivity in adults with ADHD. Your doctor may prescribe Vyvanse as part of a total treatment program that may include counseling or other therapies.

FOR HOW LONG DID VYVANSE (LISDEXAMFETAMINE DIMESYLATE) HELP IMPROVE ATTENTION IN ADULTS?

Understanding the research

Vyvanse® Study Population

Study population

142 adults aged 18-55 years with ADHD.

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Dose selection

For the first 4 weeks, everyone in the study took Vyvanse. Researchers adjusted the dose as needed to find the right dose for each person.

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Study groups

At the beginning of the fifth week, half of the group continued to take Vyvanse. The other half switched to sugar pill (placebo). Researchers and subjects didn’t know who got Vyvanse and who got the sugar pill.

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Study setting

At the end of the fifth week, during a single day, both groups were placed in a classroom-like setting designed to resemble the workplace environment.

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Testing

At 7 AM, everyone took their assigned medication—either Vyvanse or the sugar pill. Next, they began a schedule of general activities that were designed to keep study subjects busy and bring out symptoms of ADHD. After each set of activities, subjects were given the PERMP* test, which is commonly used by researchers to measure attention in ADHD. Tests were given over 14 hours at 9 AM, 11 AM, 3 PM, 5 PM, and 7 PM; the last test was at 9 PM.

*PERMP=Permanent Product Measure of Performance, a skill-adjusted math test that measures attention in ADHD. PERMP is not a test of the ability to learn math.

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Testing repeated

At the beginning of the sixth week, the group that had taken Vyvanse was switched to the sugar pill, and the group that had taken the sugar pill was switched to Vyvanse. At the end of the sixth week, study subjects were again given the timed tests under the same conditions across the day.

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Measures

Attention was measured by using the groups’ average test scores throughout the day when taking Vyvanse compared to when taking the sugar pill. Higher scores indicated improved attention.

Study results

The average of all scores throughout the day was higher when Vyvanse was taken. Vyvanse improved attention throughout the day for each timepoint tested, starting at 2 hours, and even at 14 hours after taking it.

Efficacy measured using the Permanent Product Measure of Performance (PERMP), a skill-adjusted math test that measures attention in ADHD. PERMP is not a test of the ability to learn math.

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Who should not take Vyvanse?

Do not take Vyvanse if you are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor, or MAOI, or are sensitive to, allergic to, or had a reaction to other stimulant medications. Concerned about side effects? Talk to your doctor.

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HOW DID VYVANSE (LISDEXAMFETAMINE DIMESYLATE) HELP CONTROL ADHD SYMPTOMS IN ADULTS?

Understanding the research

Vyvanse® Study Population

Study population

420 adult subjects aged 18-55 years with ADHD

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Study groups

Patients were divided into 4 groups, receiving Vyvanse 30 mg, 50 mg, or 70 mg, or sugar pill.

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Dose adjustments

Patients assigned to the Vyvanse 30 mg treatment group received this amount for 4 weeks. Patients assigned to Vyvanse 50 mg treatment received 30 mg in the first week and 50 mg for the next 3 weeks. Patients assigned to Vyvanse 70 mg treatment received 30 mg in the first week, 50 mg in the second week, and 70 mg in the next 2 weeks.

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Measures

Clinicians measured symptom level in patients at the start of the study and during every week using the ADHD-RS-IV measurement. Lower scores on the ADHD-RS-IV indicate better symptom control. Study results were based on average change in ADHD-RS-IV total score of all doses tested.

Study results

People treated with Vyvanse showed twice the symptom improvement compared to people who were treated with a sugar pill.

Results based on the Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV (ADHD-RS-IV), an investigator-rated measure of the core symptoms of ADHD.
§P<.0001 for Vyvanse vs placebo at endpoint.

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Vyvanse may not be right for everyone

Vyvanse should be taken exactly as prescribed by your doctor. Before starting Vyvanse and during treatment, tell your doctor about all health conditions (or family history of) including:

  • Any previous or current abuse of or dependency on alcohol, prescription medicine, or street drugs
  • Heart problems, heart defects, or high blood pressure
  • Mental problems, including psychosis, mania, bipolar illness, or depression
  • Circulation problems in fingers and toes
  • Any kidney problems. Your doctor may lower the dose
  • If you are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed while taking Vyvanse. Talk to your doctor about the best way to feed your baby if you take Vyvanse

WHAT WERE THE RESULTS FROM THE VYVANSE MAINTENANCE OF SYMPTOM CONTROL STUDY IN ADULTS?

Vyvanse is approved for maintenance treatment in adults

Vyvanse® Study Population

Study population

123 adults aged 18 to 55 with ADHD. Treated with Vyvanse for at least 6 months, and demonstrated a response to Vyvanse treatment with low Total Score on the ADHD Rating Scale IV (ADHD-RS-IV) and on the CGI-S.

CGI-S=Clinical Global Impressions Severity, an investigator-rated evaluation of the severity of the patient's illness at the time of assessment.

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Study length

The first part of the study was 3 weeks long. The second part was 6 weeks long.

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Study treatment

In the first part, all patients continued taking their Vyvanse daily dose for 3 weeks. In the second part, half the patients were switched to sugar pill while the other half continued on Vyvanse. This part was double-blinded, meaning neither the patients nor the clinicians knew which patients received Vyvanse and which received the sugar pill.

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Measures

Clinicians measured symptom control in patients at the start of the study and every week using the ADHD-RS-IV Total Score measurement. Lower scores on the ADHD-RS-IV indicate better symptom control. The Clinical Global Impression-Severity (CGI-S) score was also measured.

Study results

At the end of the study, 91% of people maintained ADHD symptom control with Vyvanse versus 25% with a sugar pill.

Treatment failure was defined as a ≥50% increase (worsening) in the ADHD Rating Scale IV (ADHD-RS-IV) Total Score and ≥2-point increase in the Clinical Global Impression Severity (CGI-S) score compared to scores at entry into the double-blind phase.

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Talking with your doctor

Information to help prepare you for a conversation with your doctor.

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How to take Vyvanse

Learn more about dosing and administration for Vyvanse.

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