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

NCT00702364 | Completed Results DMC

• 1 other identifier: H133A07022R01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain INjury

Keywords

Attention; Traumatic Brain INjury; Atomoxetine; Strattera

Outcome Measures

Primary Outcomes (3)

• 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,

  Post treatment

• 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.

  Post treatment

• 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.

  Post treatment

Secondary Outcomes (1)

• Neurobehavioral Functioning Inventory Depression Subscale

  Post treatment

Study Arms (2)

Atomoxetine

EXPERIMENTAL

40mg atomoxetine twice a day for 2 weeks

Drug: atomoxetine

placebo

PLACEBO COMPARATOR

Placebo twice a day for two weeks

Drug: placebo

Interventions

atomoxetine DRUG

Also known as: strattera

Atomoxetine

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Cynthia Harrison-Felix, PhD
• Organization: Craig Hospital

charrison-felix@craighospital.org

303-789-8565

Study Officials

• David L Ripley, MD

  Craig Hospital

  PRINCIPAL INVESTIGATOR

• Cindy Harrison-Felix, PhD

  Craig Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director of Research

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 20, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 15, 2014
• Results First Posted: September 15, 2014

Record last verified: 2014-08

Locations

US (1)