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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01000064
Other study ID # TBI 090563
Secondary ID
Status Completed
Phase Phase 3
First received October 15, 2009
Last updated June 3, 2015
Start date October 2009
Est. completion date May 2015

Study information

Verified date June 2015
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this drug may have on attention deficits caused by TBI are not known, but we expect that Vyvanse will be of some help in treating those types of problems as well. The study will utilize functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response.


Description:

Symptoms of inattentiveness, impulsivity, and poor persistence have been observed in both children and adults following traumatic brain injury (TBI). These often are among the most prominent symptoms manifested and may contribute to interference in a variety of other functional domains. Although there has been some use of psychostimulant medication to treat TBI-acquired attention deficits, it remains a relatively uncommon clinical practice. This study, by highlighting mechanisms of action, could serve to promote the appropriate use of this type of treatment for the patients.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date May 2015
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 45 Years
Eligibility Inclusion Criteria:

- Males and females, ages 16 to 45

- Closed head injury rated as moderate/severe (based on Glasgow Coma Scale rating, estimated posttraumatic amnesia, etc.)

- Sustained 6 to 36 months earlier, and considered to be neurologically stable

- Persistent (> 6 months) problems with focused or sustained attention (+1 SD or worse on Inattention component of ADHD self ratings) corroborated by professional staff (nurses, therapists, etc.) or caregivers. Problems with attention/concentration rated as among most prominent cognitive changes.

- Accompanying features may include diminished arousal/speed/stamina and/or disinhibited symptoms

Exclusion Criteria:

- Penetrating head injury

- Pre-injury history of diagnosed ADHD

- Other psychiatric conditions such as mania or psychosis. Current posttraumatic stress disorder (PTSD) symptoms may be present but not so severe as to require pharmacologic treatment.

- Lifetime history of psychostimulant abuse or dependence. Other (non-psychostimulant) substance abuse within the past 6 months. Total lifetime drug use will not exceed 5 times each for substances such as amphetamine, meth-amphetamine, or cocaine.

- Prior treatment with psychostimulant(s)

- Tics or other contraindications for psychostimulant use including arteriosclerosis, cardiovascular disease, uncontrolled hypertension or hyperthyroidism, glaucoma, agitation, use of MAO inhibitor within 6 weeks

- Current treatment with other psychotropic medication(s) within the past 6 weeks

- Estimated IQ < 80

- Sensory and/or motor impairment(s) seriously limiting testing options

- Other neurological conditions including epilepsy, degenerative disorders, brain tumor, or stroke.

- Physical conditions affecting arousal, activity level or stamina, including uncontrolled thyroid dysfunction, anemia, autoimmune or metabolic disorders, untreated moderate/severe sleep apnea, etc.

- Persons for whom MRI scanning is contraindicated, including weight greater than 275 pounds (due to scanner table limitations), severe claustrophobia, implanted electronic medical devices (e.g. pacemaker, cochlear or other inner ear implant, deep brain stimulator), metallic foreign object in eye or rest of the body, history of sheet metal work, aneurysm clips, non-removable metallic piercings, and dental prosthetics.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Vyvanse
30 mg - 70 mg capsules taken every morning for 6 weeks
Procedure:
fMRI
Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Locations

Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Shire

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of various components of attention, related cognitive processes, ADHD symptoms, emotional status, and quality of life ratings using various tests and scales such as Word List learning, ADHD Rating Scale, Beck Depression Inventory, etc. 12 weeks No
Secondary Evaluation of which types of patients are most likely to benefit from treatment. 12 weeks No
Secondary The study will utilize fMRI methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response. 12 weeks No
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