NCT02712996

Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children

Treatment Outcomes With Lisdexamfetamine Dimesylate (Vyvanse) in Children With Traumatic Brain Injury-Related Attention Deficits

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help children ages 6-16 with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this drug may have on adults with attention deficits caused by TBI have been investigated prior. The exact effects this drug may have on children with attention deficits caused by TBI are not known, but the investigators expect that Vyvanse will be of some help in treating this population as well.

Detailed description

Symptoms of inattentiveness, impulsivity, and poor persistence have been observed in children following traumatic brain injury (TBI). These often are among the most prominent symptoms manifested and may contribute to interference in a variety of other functional domains. Although there has been some use of psychostimulant medication to treat TBI-acquired attention deficits, it remains a relatively uncommon clinical practice. This study, by highlighting mechanisms of action, could serve to promote the appropriate use of this type of treatment for the patients.

Conditions

• Traumatic Brain Injury
• Attention Deficit Disorder

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine	Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.
DRUG	Placebo	Placebo capsule, 20-70 mg, each morning for 6 weeks.

Timeline

• Start date: 2017-02-06
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2016-03-18
• Last updated: 2020-07-13
• Results posted: 2020-07-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study