Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI) - Full Text View

Sponsored by:	Craig Hospital
Information provided by:	Craig Hospital
ClinicalTrials.gov Identifier:	NCT00702364

Purpose

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
Traumatic Brain Injury	Drug: Atomoxetine

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

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

Further study details as provided by Craig Hospital:

Primary Outcome Measures:

Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [ Time Frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks post-baseline ] [ Designated as safety issue: No ]
Stroop Test [ Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks post-baseline ] [ Designated as safety issue: No ]
Adult ADHD Self-Report Scale [ Time Frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neurobehavioral Functioning Inventory [ Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks post-baseline ] [ Designated as safety issue: No ]

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)

Intervention Details:

40 mg atomoxetine twice a day at 7am and noon for 2 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of TBI
Moderate to severe TBI as indicated by GCS score of 12 or less; or PTA of seven days or more
Received inpatient rehabilitation for TBI at Craig Hospital
at least one year post injury
between the ages of 18-65 (inclusive)
symptoms consistent with attentional dysfunction
use of any previously prescribed stimulant medications must be stopped at least 4 weeks prior to start of study
consent ot 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 axidase inhibitor or any other drug affecting brain monoamine concentrations
severe renal or hepatic impairment
pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702364

Contacts

Contact: Clare E Morey, MA

303-789-8621

cmorey@craighospital.org

Locations

United States, Colorado
Craig Hospital	Recruiting
Englewood, Colorado, United States, 80113
Principal Investigator: David L Ripley, MD

Sponsors and Collaborators

Craig Hospital

Investigators

Principal Investigator:	David L Ripley, MD	Craig Hospital
Principal Investigator:	Cindy Harrison-Felix, PhD	Craig Hospital

More Information

No publications provided

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Craig Hospital:

Attention
Traumatic Brain INjury
Atomoxetine
Strattera

Study placed in the following topic categories:

Craniocerebral Trauma
Neurotransmitter Agents
Adrenergic Agents
Wounds and Injuries
Atomoxetine

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Craniocerebral Trauma
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases

Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Atomoxetine
Trauma, Nervous System
Brain Diseases
Pharmacologic Actions
Brain Injuries

ClinicalTrials.gov processed this record on May 07, 2009