The primary objectives of the proposed career development activities are to provide the expanded knowledge base, skills in clinical trial design and analysis, and research experiences that I need to become an independent investigator with a focus on intervention research in children and adolescents with psychotic disorders. There is a dearth of research, particularly psychopharmacologic, on the treatment of psychotic disorders in youth. My primary interest is to determine the acute and long-term efficacy and tolerability of specific antipsychotics in youth with schizophrenia spectrum illnesses. Intermediate goals are to develop safer and more effective treatments for psychosis in children. Ultimately the skills and knowledge gained in the course of this career development program will increase my ability to use the results of intervention studies to make inferences about the pathophysiology of pediatric psychotic disorders. The skills gained in the course of this award will also Generalize to rigorous intervention studies in other severe neurodevelopmental disorders like autism. My career development plan includes 1) didactic courses in the design and analysis of clinical trials, 2) tutorials with experts in child psychiatry clinical trials, in the analysis and regulatory implications of clinical trials, and in childhood schizophrenia, and 3) research activities mentored by Dr. Jeff Lieberman involving the evaluation of atypical antipsychotics in pediatric psychosis. The mentored research activities that I propose are 1) a multisite, randomized, controlled trial (TEOSS, which was recently funded), 2) an open, prospective study of long-term outcome for youth treated with antipsychotics, and 3) pilot studies of newly developed antipsychotics. Project 1, TEOSS, compares the efficacy and tolerability of molindone, risperidone, and olanzapine in schizophrenia and schizoaffective in children and adolescents. Project 2 examines relapse incidence over three years in psychotic youth initially treated with different antipsychotics. Project 3 consists of pilot studies of newly developed antipsychotics including ziprasidone, aripiprazole, and iloperidone. Coordinating projects ? and 3 with TEOSS will'allow me to use many of the same case report forms, the same database systems, and similar analyses. Further, it will be possible to generally compare data between projects. This career development plan and the proposed research activities will greatly facilitate my transition from a clinician to one of the handful of independent investigators focused on intervention studies in youth with psychotic illnesses.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23MH001802-03
Application #
6736859
Study Section
Special Emphasis Panel (ZMH1-ITV-D (01))
Program Officer
Boyce, Cheryl A
Project Start
2002-04-01
Project End
2007-03-31
Budget Start
2004-04-01
Budget End
2005-03-31
Support Year
3
Fiscal Year
2004
Total Cost
$172,227
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Psychiatry
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Frazier, Jean A; Giuliano, Anthony J; Johnson, Jacqueline L et al. (2012) Neurocognitive outcomes in the Treatment of Early-Onset Schizophrenia Spectrum Disorders study. J Am Acad Child Adolesc Psychiatry 51:496-505
Findling, Robert L; Johnson, Jacqueline L; McClellan, Jon et al. (2010) Double-blind maintenance safety and effectiveness findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) study. J Am Acad Child Adolesc Psychiatry 49:583-94; quiz 632
Hooper, Stephen R; Giuliano, Anthony J; Youngstrom, Eric A et al. (2010) Neurocognition in early-onset schizophrenia and schizoaffective disorders. J Am Acad Child Adolesc Psychiatry 49:52-60
Frazier, Jean A; McClellan, Jon; Findling, Robert L et al. (2007) Treatment of early-onset schizophrenia spectrum disorders (TEOSS): demographic and clinical characteristics. J Am Acad Child Adolesc Psychiatry 46:979-88
Bethea, Terrence C; Sikich, Linmarie (2007) Early pharmacological treatment of autism: a rationale for developmental treatment. Biol Psychiatry 61:521-37