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

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ClinicalTrials.gov Identifier: NCT00702364
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Cynthia Harrison-Felix, PhD, Craig Hospital

Study Description
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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 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 or disease Intervention/treatment Phase
Traumatic Brain INjury Drug: atomoxetine Drug: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury
Study Start Date : January 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Atomoxetine
40mg atomoxetine twice a day for 2 weeks
 Drug: atomoxetine
Other Name: strattera
Placebo Comparator: placebo
Placebo twice a day for two weeks
 Drug: placebo


Outcome Measures
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Primary Outcome Measures :
  1. CDR Power of Attention [ Time Frame: Post treatment ]

    Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [19] is comprised of a battery of computer-controlled tasks administered on a laptop computer with parallel forms of the tests being presented on each testing session. The Power of Attention factor of the CDR was selected as the primary outcome measure because of its strong psychometric properties in other drug studies with cognitively compromised populations.

    Instead of utilizing a t-test to compare treatment and control groups, treatment and control groups for both primary and secondary outcomes were compared utilizing an analysis of covariance (ANCOVA) model in which repeat baseline measures taken on each respective outcome served as a covariate. This method controls for any differences that may exist between the groups at baseline. Model assumptions for conducting an ANCOVA were investigated for all primary and secondary analyses, where no violations of model assumptions were detected. Additionally,


  2. Stroop Test Interference T-score [ Time Frame: Post treatment ]
    The Stroop Color and Word Test is frequently used to study deficits of attention and executive function in individuals with TBI, and has adequate test-retest reliability. At each administration, the following scores were obtained, Word Reading, Colour Naming and Interference. Raw scores were converted to demographically-adjusted T-scores using Golden and Freshwater norm.

  3. Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score [ Time Frame: Post treatment ]
    The Adult ADHD Self-Report Scale (ASRS-v1.1) is a self-report questionnaire that consists of questions involving the 18-items of the The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV- Text Revision (TR) criteria for ADHD that rate symptoms on a Likert scale ranging from 0-4 based on the frequency of symptoms ("never", "rarely", "sometimes", "often", and "very often"). A previous study of the ASRS found the self-report to be both valid (Cronbach's alpha =.88) and reliable (ICC=.84). Scores on the 18 items were summed for a total ASRS score.


Secondary Outcome Measures :
  1. Neurobehavioral Functioning Inventory Depression Subscale [ Time Frame: Post treatment ]
    Neurobehavioral Functioning Inventory (NFI) was developed as a clinical and research tool to quantify a variety of post-injury behaviours and symptoms characteristic of neurologic disability and encountered in daily life. The inventory is comprised of 76 items organized into six analytically derived factor scales: Depression, Somatic, Memory/Attention, Communication, Aggression, and Motor. Respondents are asked to rate items as occurring "never", "rarely", "sometimes", "often", or "always". Using the standardized scoring procedures outlined in the NFI Manual, T-scores were calculated for the Depression sub-scale. Lower T-score indicates less depressive symptomotology.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702364


Locations
United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80113
Sponsors and Collaborators
Craig Hospital
Investigators
Principal Investigator: David L Ripley, MD Craig Hospital
Principal Investigator: Cindy Harrison-Felix, PhD Craig Hospital
More Information
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Responsible Party: Cynthia Harrison-Felix, PhD, Assistant Director of Research, Craig Hospital
ClinicalTrials.gov Identifier: NCT00702364     History of Changes
Other Study ID Numbers: H133A07022R01
First Posted: June 20, 2008    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014
Last Verified: August 2014

Keywords provided by Cynthia Harrison-Felix, PhD, Craig Hospital:
Attention
Traumatic Brain INjury
Atomoxetine
Strattera

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurocognitive Disorders
 Mental Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs