Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)

Official Title: “Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury”

Atomoxetine is the only medication that is currently approved by the FDA for the treatment of attention deficit hyperactivity disorder in adults. It has gained recent interest as an alternative medication for treating attentional problems related to traumatic brain injury (TBI), but it's effectiveness in this population has not been studied. There are a number of advantages of Atomoxetine over traditional neuro-stimulant medications currently used for attentional disorders after traumatic brain injury. This study will use a randomized double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine to improve attention, behavioral function, and depression in adults with TBI

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • 40 mg atomoxetine twice a day at 7am and noon for 2 weeks

Primary Measures

• Cognitive Drug Research (CDR) Computerized Cognitive Assessment System
  • Time Frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks post-baseline
    Safety Issue?: No
• Stroop Test
  • Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks post-baseline
    Safety Issue?: No
• Adult ADHD Self-Report Scale
  • Time Frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks post-baseline
    Safety Issue?: No

Secondary Measures

• Neurobehavioral Functioning Inventory
  • Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks post-baseline
    Safety Issue?: No

Inclusion Criteria:

• History of TBI
• Moderate to severe TBI as indicated by GCS score of 12 or less; or PTA of seven days or more
• at least one year post injury
• between the ages of 18-65 (inclusive)
• symptoms consistent with attentional dysfunction
• consent to participate in study

Exclusion Criteria:

• history of any conditions that would prohibit standard neuropsychological testing
• non-English speaking (to the extent that would limit ability to complete study measures)
• prior history of significant psychiatric illness requiring hospitalization
• epilepsy
• cardiovascular disease or risks including: dysrhythmias, angina, myocardial infarction, uncontrolled hypertension, valvular heart disease including mitral valve prolapse
• use of any monoamine axidase inhibitor or any other drug affecting brain monoamine concentrations
• severe renal or hepatic impairment
• pregnant or lactating

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Craig Hospital Other

Overall Clinical Trial Officials and Contacts

David L Ripley, MD Principal Investigator Craig Hospital  

Overall Contact: Clare E Morey, MA 303-789-8621 cmorey@craighospital.org

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00702364

Study ID Number: H133A07022R01

ClinicalTrials.gov Identifier: NCT00702364

Health Authority: United States: Institutional Review Board