Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
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ClinicalTrials.gov Identifier: NCT00702364 |
Recruitment Status
:
Completed
First Posted
: June 20, 2008
Results First Posted
: September 15, 2014
Last Update Posted
: September 15, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Traumatic Brain INjury | Drug: atomoxetine Drug: placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Atomoxetine
40mg atomoxetine twice a day for 2 weeks
|
Drug: atomoxetine
Other Name: strattera
|
Placebo Comparator: placebo
Placebo twice a day for two weeks
|
Drug: placebo |
- CDR Power of Attention [ Time Frame: Post treatment ]
Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [19] 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History of TBI
- Moderate to severe TBI as indicated by Glasgow Coma Score (GCS) score of 12 or less; or Post Traumatic Amnesia (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 oxidase inhibitor or any other drug affecting brain monoamine concentrations
- severe renal or hepatic impairment
- pregnant or lactating

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 | |
Craig Hospital | |
Englewood, Colorado, United States, 80113 |
Principal Investigator: | David L Ripley, MD | Craig Hospital | |
Principal Investigator: | Cindy Harrison-Felix, PhD | Craig Hospital |
Responsible Party: | Cynthia Harrison-Felix, PhD, Assistant Director of Research, Craig Hospital |
ClinicalTrials.gov Identifier: | NCT00702364 History of Changes |
Other Study ID Numbers: |
H133A07022R01 |
First Posted: | June 20, 2008 Key Record Dates |
Results First Posted: | September 15, 2014 |
Last Update Posted: | September 15, 2014 |
Last Verified: | August 2014 |
Keywords provided by Cynthia Harrison-Felix, PhD, Craig Hospital:
Attention Traumatic Brain INjury Atomoxetine Strattera |
Additional relevant MeSH terms:
Wounds and Injuries Brain Injuries Brain Injuries, Traumatic Cognition Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Neurocognitive Disorders |
Mental Disorders Atomoxetine Hydrochloride Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs |