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: February 14, 2013
Last verified: February 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover 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:
  • 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 ]

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
Placebo Comparator: Placebo Drug: Atomoxetine
40 mg atomoxetine twice a day at 7am and noon for 2 weeks
Other Name: Strattera

  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
  • 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 axidase 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
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014