Back to resultsEfficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
Primary Purpose
Traumatic Brain INjury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
atomoxetine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain INjury focused on measuring Attention, Traumatic Brain INjury, Atomoxetine, Strattera
Eligibility 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
Sites / Locations
- Craig Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Atomoxetine
placebo
Arm Description
40mg atomoxetine twice a day for 2 weeks
Placebo twice a day for two weeks
Outcomes
Primary Outcome Measures
CDR Power of Attention
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00702364
Brief Title
Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
Official Title
Strattera(Atomoxetine) for the Treatment of Attention Disorders in Individuals With Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Craig Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain INjury
Keywords
Attention, Traumatic Brain INjury, Atomoxetine, Strattera
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atomoxetine
Arm Type
Experimental
Arm Description
40mg atomoxetine twice a day for 2 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice a day for two weeks
Intervention Type
Drug
Intervention Name(s)
atomoxetine
Other Intervention Name(s)
strattera
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
CDR Power of Attention
Description
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,
Time Frame
Post treatment
Title
Stroop Test Interference T-score
Description
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.
Time Frame
Post treatment
Title
Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score
Description
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.
Time Frame
Post treatment
Secondary Outcome Measure Information:
Title
Neurobehavioral Functioning Inventory Depression Subscale
Description
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.
Time Frame
Post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Ripley, MD
Organizational Affiliation
Craig Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cindy Harrison-Felix, PhD
Organizational Affiliation
Craig Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
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