Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
Completed · Not applicable · Has a placebo group
Conditions studied: Traumatic Brain INjury
In brief
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
Key facts
- Study ID
- NCT00702364
- Run by
- Craig Hospital
- People needed
- 60
- Starts
- 2008-01-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2014-09-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Craig Hospital — Englewood, Colorado, United States
Full record on ClinicalTrials.gov
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