Lead Center:The Rocky Mountain Regional Brain Injury System
Principal Investigator Name:Cynthia Harrison-Felix, PhD
Principal Investigator Email:email@example.com
Target Population(s):Participants include people between the ages of 18 - 65 (inclusive), at least one year post moderate to severe TBI, who have received in-patient rehabilitation and who have symptoms consistent with attentional dysfunction.
Atomoxetine (Strattera), a selective norepinephrine reuptake inhibitor, is the only medication that is currently approved for the treatment of attention deficit hyperactivity disorder (ADHD) in adults by the Food and Drug Administration (FDA). It has gained considerable interest as an alternative medication for treating TBI-related attentional problems and related sequelae; however, it has not been empirically tested in the TBI population for this indication. Advantages atomoxetine holds over traditional neurostimulant medications include less sympathomimetic side effects, a more specific physiological mechanism of action, potential concomitant use as an antidepressant, less potential for abuse, and greater ease/convenience for prescription, as it is not an FDA Schedule II medication. This study will use a randomized double-blind placebo-controlled crossover study design to investigate the efficacy of Atomoxetine to improve attention, behavioral functioning, and depression in individuals with TBI. The objectives of this study are to conduct a randomized controlled trial to test three hypotheses: 1) Atomoxetine will improve attention in individuals with TBI as measured by the CDR Computerized Cognitive Assessment - Power of Attention Factor, the Stroop Test, and the Adult ADHD Self-Report Scale (ASRS-v1.1). 2) Atomoxetine will improve behavioral functioning in individuals with TBI as measured by both participant and family/caregiver ratings on the Neurobehavioral Functioning Inventory (NFI). 3) Atomoxetine will improve depression in individuals with TBI as measured by the Depression subscale of the NFI. In addition, project objectives include preparing a professional manuscript based on baseline characteristics, a professional manuscript of randomized trial results, a consumer manuscript of results and up to six presentations to professional and consumer groups.