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

NCT01000064 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-05-19

Study results available
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Summary

The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help 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 attention deficits caused by TBI are not known, but we expect that Vyvanse will be of some help in treating those types of problems as well. The study will utilize functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response.

Conditions

Interventions

DRUG

Vyvanse

30 mg - 70 mg capsules taken every morning for 6 weeks.

PROCEDURE

fMRI

Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

DRUG

Placebo

Placebo capsules taken every morning for 6 weeks.

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Michael G Tramontana, Ph.D. · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-12-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01000064 on ClinicalTrials.gov