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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Traumatic Brain INjury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atomoxetine

40mg atomoxetine twice a day for 2 weeks

Group Type EXPERIMENTAL

atomoxetine

Intervention Type DRUG

placebo

Placebo twice a day for two weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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atomoxetine

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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strattera

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No