Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury|
- CDR Power of Attention [ Time Frame: Post treatment ] [ Designated as safety issue: No ]
Cognitive Drug Research (CDR) Computerized Cognitive Assessment System  is comprised of a battery of computer-controlled tasks administered on a laptop computer with parallel forms of the tests being presented on each testing session. The Power of Attention factor of the CDR was selected as the primary outcome measure because of its strong psychometric properties in other drug studies with cognitively compromised populations.
Instead of utilizing a t-test to compare treatment and control groups, treatment and control groups for both primary and secondary outcomes were compared utilizing an analysis of covariance (ANCOVA) model in which repeat baseline measures taken on each respective outcome served as a covariate. This method controls for any differences that may exist between the groups at baseline. Model assumptions for conducting an ANCOVA were investigated for all primary and secondary analyses, where no violations of model assumptions were detected. Additionally,
- Stroop Test Interference T-score [ Time Frame: Post treatment ] [ Designated as safety issue: No ]The Stroop Color and Word Test is frequently used to study deficits of attention and executive function in individuals with TBI, and has adequate test-retest reliability. At each administration, the following scores were obtained, Word Reading, Colour Naming and Interference. Raw scores were converted to demographically-adjusted T-scores using Golden and Freshwater norm.
- Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score [ Time Frame: Post treatment ] [ Designated as safety issue: No ]The Adult ADHD Self-Report Scale (ASRS-v1.1) is a self-report questionnaire that consists of questions involving the 18-items of the The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV- Text Revision (TR) criteria for ADHD that rate symptoms on a Likert scale ranging from 0-4 based on the frequency of symptoms ("never", "rarely", "sometimes", "often", and "very often"). A previous study of the ASRS found the self-report to be both valid (Cronbach's alpha =.88) and reliable (ICC=.84). Scores on the 18 items were summed for a total ASRS score.
- Neurobehavioral Functioning Inventory Depression Subscale [ Time Frame: Post treatment ] [ Designated as safety issue: No ]Neurobehavioral Functioning Inventory (NFI) was developed as a clinical and research tool to quantify a variety of post-injury behaviours and symptoms characteristic of neurologic disability and encountered in daily life. The inventory is comprised of 76 items organized into six analytically derived factor scales: Depression, Somatic, Memory/Attention, Communication, Aggression, and Motor. Respondents are asked to rate items as occurring "never", "rarely", "sometimes", "often", or "always". Using the standardized scoring procedures outlined in the NFI Manual, T-scores were calculated for the Depression sub-scale. Lower T-score indicates less depressive symptomotology.
|Study Start Date:||January 2008|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
40mg atomoxetine twice a day for 2 weeks
Other Name: strattera
Placebo Comparator: placebo
Placebo twice a day for two weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702364
|United States, Colorado|
|Englewood, Colorado, United States, 80113|
|Principal Investigator:||David L Ripley, MD||Craig Hospital|
|Principal Investigator:||Cindy Harrison-Felix, PhD||Craig Hospital|