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STUDY RESULTS

Learning about ADHD medication for children
between the ages of 6 and 17?

Talk to your child's doctor about Vyvanse and explore the clinical study results below.

Vyvanse clinical study results

VYVANSE HELPED TREAT ADHD THROUGHOUT THE DAY IN CHILDREN (AGED 6-12)

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Study population

129 kids aged 6 to 12 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 was switched to sugar pill. Researchers and patients 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. At 7 AM, everyone took their assigned medication—either Vyvanse or the sugar pill. During the day, children were given individual and group activities just like a real classroom.

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Study evaluations

During the classroom day, researchers with special training evaluated the children for ADHD behaviors using a scientific method called the SKAMP scale. The goal of the study was to use the part called SKAMP-D to measure behavior.

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Evaluations repeated

At the beginning of the sixth week, the group that had taken Vyvanse was switched to sugar pill, and the group that had taken sugar pill was switched to Vyvanse. At the end of the sixth week, patients were again evaluated in the same classroom-like setting using the SKAMP-D scale.

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Measures

On the SKAMP-D scale, lower scores indicate improved behavior.

In one study of kids (aged 6-12) with ADHD, Vyvanse (lisdexamfetamine dimesylate) demonstrated ADHD symptom control for up to 13 hours, starting at 1.5 hours after taking it.*

Individual results may vary.

  • When taken at 7 AM, Vyvanse provided ADHD symptom control at 8:30 AM.
  • Vyvanse demonstrated ADHD symptom control throughout the day and into the evening—
    even at 8 PM.

*Results based on the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment Scores (SKAMP-D) subscale, a validated classroom assessment tool that measures behavior problems leading to classroom disruptions. It is not a measure of academic performance.

Duration of ADHD symptom control has not been studied in teens (ages 13-17).

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Who should not take Vyvanse?

Your child should not take Vyvanse if he or she:

  • Is taking, or has taken within the past 14 days, an anti-depression medicine called a monoamine oxidase inhibitor (MAOI).
  • Is sensitive to, allergic to, or had a reaction to other stimulant medicines.
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VYVANSE HELPED IMPROVE ADHD SYMPTOMS
IN CHILDREN AGED 6-12

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Study population

290 kids aged 6 to 12 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 30 mg Vyvanse treatment received this amount for 4 weeks. Patients assigned to 50 mg Vyvanse treatment received 30 mg in the first week and 50 mg for the next 3 weeks. Patients assigned to 70 mg Vyvanse treatment received 30 mg in the first week, 50 mg in the second week, and then 70 mg for the next 2 weeks.

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Measures

Clinicians measured symptom control in patients at the start of the study and during every week using the ADHD Rating Scale-IV (ADHD-RS-IV) measurement. Lower scores on the ADHD-RS-IV indicate better symptom control. Parents assessed their children's ADHD symptoms using the Conners' Parent Rating Scale (CPRS) at about 10 AM, 2 PM, and 6 PM. Lower scores indicate fewer symptoms.

  • In a clinical study of 290 kids (aged 6-12) with ADHD, Vyvanse was compared with a sugar pill for 4 weeks.
  • From the start to the end of the study, patients given Vyvanse showed a 56% improvement in ADHD symptoms (average ADHD-RS-IV total score, reduced from 43.9 to 19.5), whereas patients given the sugar pill showed a 14% improvement in ADHD symptoms (average ADHD-RS-IV total score reduced from 42.4 to 36.6).
  • Parents reported symptom improvement in the morning, in the afternoon, and into the early evening.

Based on Conners’ Parent Rating Scale

VYVANSE HELPED IMPROVE ADHD SYMPTOMS 
IN TEENS AGED 13-17

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Study population

314 teens aged 13 to 17 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 30 mg Vyvanse treatment received this amount for 4 weeks. Patients assigned to 50 mg Vyvanse treatment received 30 mg in the first week and 50 mg for the next 3 weeks. Patients assigned to 70 mg Vyvanse treatment received 30 mg in the first week, 50 mg in the second week, and then 70 mg for the next 2 weeks.

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Measures

Clinicians measured symptom control in patients at the start of the study and during every week using the ADHD Rating Scale-IV (ADHD-RS-IV) total score measurement. Lower scores on the ADHD-RS-IV indicate better symptom control.

In a 4-week clinical study of teens (aged 13-17) with ADHD, Vyvanse (lisdexamfetamine dimesylate) was shown to improve the symptoms of ADHD.

  • Vyvanse was shown to improve attention and reduce the symptoms of hyperactivity and impulsivity.

Based on the ADHD Rating Scale IV (ADHD-RS-IV) Total Score
Individual results may vary.

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Vyvanse may not be right for everyone

Your child should take Vyvanse exactly as the doctor tells him or her to take it.
Before getting started on Vyvanse, it's important to know the potential risks of treatments.

Tell the doctor if your child:

  • has heart problems or heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects taking stimulant medicines, and sudden death, stroke, and heart attack have happened in adults taking stimulant medicines. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call the doctor right away if your child have any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking Vyvanse.

  • has mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.

  • has circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Fingers or toes may feel numb, cool, painful, and/or sensitive to temperature and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking Vyvanse.

MAINTENANCE STUDY IN CHILDREN & TEENS AGED 6-17

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Study population

157 children aged 6 to 17  with ADHD.

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Study length

The study had 4 parts. The first part of the study was 4 weeks, followed by a 20-week-long period, then 2 weeks, and then 6 weeks.

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Study treatment

In the first part, for 4 weeks, all patients were treated with Vyvanse to find the best dose for them. They continued taking their Vyvanse at the best daily dose for 20 weeks, but doses could be changed if necessary. In the third part, researchers evaluated all patients and collected information on their dose; no changes were allowed during this time. Patients who showed a high level of ADHD symptoms during this period did not continue in the study. In the fourth 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 Rating Scale-IV (ADHD-RS-IV) measurement. Lower scores on the ADHD-RS-IV indicate better symptom control. The Clinical Global Impression-Severity (CGI-S) score was also measured.

Vyvanse is approved for maintenance treatment of ADHD in children between the
ages of 6 and 17.

  • A study in children (aged 6-17) with ADHD who took Vyvanse for at least 6 months, and whose symptoms were well controlled, evaluated the benefit of extended treatment with Vyvanse.
  • During the first 4 weeks of the study, children were started on a dose of Vyvanse; the dose was adjusted as needed. They maintained treatment at this dose for the next 20 weeks.
  • After 2 weeks of observation without any changes to the dose, children were randomly placed in 1 of 2 groups for 6 weeks; half of the children continued to take Vyvanse, while the other half were switched to sugar pill.
  • The results? At the end of the study, 15.8% of children receiving Vyvanse met the treatment failure* criteria, compared with 67.5% receiving the sugar pill.

§"Treatment failure" (loss of symptom control) was defined as a 50% or greater increase (worsening) in the ADHD-RS-IV Total Score and a 2-point increase or greater (worsening) in the Clinical Global Impression-Severity score, compared to scores at entry into the double-blind phase.

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Talking with your child's doctor

Information to help prepare you for the conversation with your child's doctor.

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How to take Vyvanse

Learn more about dosing and administration for Vyvanse.

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