N/A
Completed N=55
Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
Source: ClinicalTrials.gov NCT00702364 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: CDR Power of Attention — 1262.1744; 1252.9510 msec
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CDR Power of Attention |
1262.1744; 1252.9510 | — |
| PRIMARY Stroop Test Interference T-score |
56.50; 55.44 | — |
| PRIMARY Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score |
28.883; 30.997 | — |
| SECONDARY Neurobehavioral Functioning Inventory Depression Subscale |
27.53; 29.47 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00702364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.