Status:
COMPLETED
Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
Lead Sponsor:
Craig Hospital
Conditions:
Traumatic Brain INjury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 medica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00702364
Start Date
January 1 2008
End Date
March 1 2012
Last Update
September 15 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Craig Hospital
Englewood, Colorado, United States, 80113