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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Harrison-Felix, PhD, Craig Hospital
ClinicalTrials.gov Identifier:
NCT00702364
First received: June 18, 2008
Last updated: August 28, 2014
Last verified: August 2014
  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
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Craig Hospital:

Primary Outcome Measures:
  • CDR Power of Attention [ Time Frame: Post treatment ] [ Designated as safety issue: No ]

    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,


  • Stroop Test Interference T-score [ Time Frame: Post treatment ] [ Designated as safety issue: No ]
    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.

  • Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score [ Time Frame: Post treatment ] [ Designated as safety issue: No ]
    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:
  • Neurobehavioral Functioning Inventory Depression Subscale [ Time Frame: Post treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: January 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Cynthia Harrison-Felix, PhD, Assistant Director of Research, Craig Hospital
ClinicalTrials.gov Identifier: NCT00702364     History of Changes
Other Study ID Numbers: H133A07022R01
Study First Received: June 18, 2008
Results First Received: September 3, 2013
Last Updated: August 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Craig Hospital:
Attention
Traumatic Brain INjury
Atomoxetine
Strattera

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Atomoxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014