The purpose of this K23 proposal is to prepare the candidate to become an independent investigator, able to design, acquire funding for, and perform valid clinical trials in children with co-occurring neurologic and psychiatric disorders. The candidate proposes a unique and well- integrated combination of educational experiences: 1) mentorship with established clinical trials researchers in psychiatry, neurology, and outcomes research; and 2) a rigorous master's training program in statistics and research design, with 30 hours of classroom time per month over 18 months. The candidate proposes to implement the lessons learned in a clinical effectiveness trial of multi-drug treatments in children and adolescents with Tourette's Syndrome, a paradigm disorder of co-occurring neurologic and psychiatric symptoms. Tourette's Syndrome is a neuropsychiatric disorder characterized by greater than one year of motor and vocal tics that are functionally or socially disturbing. Children and adolescents frequently have multiple co-occurring neuropsychiatric diagnoses and are treated with combinations of medications that have never been tested together. Current clinical research typically involves efficacy studies of monotherapy that may have limited clinical relevance. The research proposal of this K award includes a randomized controlled clinical effectiveness study of a dopamine agonist, pergolide, allowing for concurrent treatment of comorbid disorders. The primary hypothesis is that treatment with pergolide will be associated with significant tic suppression, independent of concurrent treatment for OCD or ADHD. The study will have the power to determine whether the presence of treated co-morbid OCD or ADHD accounts for significant variance in the change in tic symptoms on medication. An additional focus of the grant will be developing measures of health care utilization and costs in this disorder and determining their relationship to the presence of absence of effective symptom management.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
1K23NS041920-01
Application #
6358591
Study Section
Special Emphasis Panel (ZRG1-BDCN-5 (01))
Program Officer
Finkelstein, Robert
Project Start
2001-08-15
Project End
2006-07-31
Budget Start
2001-08-15
Budget End
2002-07-31
Support Year
1
Fiscal Year
2001
Total Cost
$125,010
Indirect Cost
Name
Cincinnati Children's Hospital Medical Center
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
Lit, Lisa; Enstrom, Amanda; Sharp, Frank R et al. (2009) Age-related gene expression in Tourette syndrome. J Psychiatr Res 43:319-30
Gilbert, Donald L; Zhang, Jie; Lipps, Tara D et al. (2007) Atomoxetine treatment of ADHD in Tourette syndrome: reduction in motor cortex inhibition correlates with clinical improvement. Clin Neurophysiol 118:1835-41
Lit, Lisa; Gilbert, Donald L; Walker, Wynn et al. (2007) A subgroup of Tourette's patients overexpress specific natural killer cell genes in blood: a preliminary report. Am J Med Genet B Neuropsychiatr Genet 144B:958-63
Gilbert, D L; Christian, B T; Gelfand, M J et al. (2006) Altered mesolimbocortical and thalamic dopamine in Tourette syndrome. Neurology 67:1695-7
Gilbert, Donald L; Wang, Zhewu; Sallee, Floyd R et al. (2006) Dopamine transporter genotype influences the physiological response to medication in ADHD. Brain 129:2038-46
Gilbert, Donald L (2006) Motor cortex inhibitory function in Tourette syndrome, attention deficit disorder, and obsessive compulsive disorder: studies using transcranial magnetic stimulation. Adv Neurol 99:107-14
Gilbert, Donald L; Ridel, Keith R; Sallee, Floyd R et al. (2006) Comparison of the inhibitory and excitatory effects of ADHD medications methylphenidate and atomoxetine on motor cortex. Neuropsychopharmacology 31:442-9
Gilbert, Donald L; Sallee, Floyd R; Zhang, Jie et al. (2005) Transcranial magnetic stimulation-evoked cortical inhibition: a consistent marker of attention-deficit/hyperactivity disorder scores in tourette syndrome. Biol Psychiatry 57:1597-600
Gilbert, Donald L; Buncher, C Ralph (2005) Assessment of scientific and ethical issues in two randomized clinical trial designs for patients with Tourette's syndrome: a model for studies of multiple neuropsychiatric diagnoses. J Neuropsychiatry Clin Neurosci 17:324-32
Tang, Yang; Gilbert, Donald L; Glauser, Tracy A et al. (2005) Blood gene expression profiling of neurologic diseases: a pilot microarray study. Arch Neurol 62:210-5

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