Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00702364|
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain INjury||Drug: atomoxetine Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
40mg atomoxetine twice a day for 2 weeks
Other Name: strattera
Placebo Comparator: placebo
Placebo twice a day for two weeks
- CDR Power of Attention [ Time Frame: Post treatment ]
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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|