Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)

Craig Hospital

Status: Completed

Conditions: Traumatic Brain INjury

Treatments: Drug: placebo; Drug: atomoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT00702364

H133A07022R01

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Atomoxetine

Experimental group

Description:

40mg atomoxetine twice a day for 2 weeks

Treatment:

Drug: atomoxetine

placebo

Placebo Comparator group

Description:

Placebo twice a day for two weeks

Treatment:

Drug: placebo