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Sponsored by: |
Craig Hospital |
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Information provided by: | Craig Hospital |
ClinicalTrials.gov Identifier: | NCT00702364 |
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
Condition | Intervention |
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Traumatic Brain Injury |
Drug: Atomoxetine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury |
Estimated Enrollment: | 60 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clare E Morey, MA | 303-789-8621 | cmorey@craighospital.org |
United States, Colorado | |
Craig Hospital | Recruiting |
Englewood, Colorado, United States, 80113 | |
Principal Investigator: David L Ripley, MD |
Principal Investigator: | David L Ripley, MD | Craig Hospital |
Principal Investigator: | Cindy Harrison-Felix, PhD | Craig Hospital |
Responsible Party: | Craig Hospital ( David Ripley, MD ) |
Study ID Numbers: | H133A07022R01 |
Study First Received: | June 18, 2008 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00702364 |
Health Authority: | United States: Institutional Review Board |
Attention Traumatic Brain INjury Atomoxetine Strattera |
Craniocerebral Trauma Wounds and Injuries Atomoxetine Disorders of Environmental Origin |
Central Nervous System Diseases Trauma, Nervous System Brain Diseases Brain Injuries |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents |
Adrenergic Uptake Inhibitors Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |