Research

Unique, innovative, cutting edge, impactful, and relevant are adjectives that describe the research conducted in the Department of Psychiatry and Behavioral Sciences at the KU School of Medicine-Wichita. The department is the only department of psychiatry in the country to have a dedicated Phase I unit for drug development studies. The unit is housed in the Clinical Research Institute (CRI).

CRI is directed by Sheldon H. Preskorn, MD, professor. Dr. Preskorn has more than 20 years of experience in drug development research in all phases, from preclinical pharmacology through drug registration hearings. Other faculty members involved in studies include: Michael J. Burke, MD, Lyle Baade, PhD, Connie Marsh, MD, Ahsan Khan, MD and C. Don Morgan, PhD.

Through CRI research conducted in the department is at the leading edge of new drug development for central nervous diseases including:

The department is nationally and internationally recognized for this research and is routinely represented at all major psychopharmacological and drug development meetings in the United States and throughout the world.

By having both a Phase I Unit and a Clinical Trials Unit investigator in the department, we are able to be involved at each phase of a new drug's development, from first time in man and specialized pharmacokinetic studies through phase II and III clinical trials. That continuity permits midcourse corrections resulting in improved research efficiency, reducing time needed to make "go/no" drug development decisions and increasing the yield on studies undertaken.

In addition to more conventional drug development studies, research includes studies in specialized populations and the use of surrogate markers for response. Studies conducted by department investigators have spanned virtually the entire human life span from children and adolescents to seniors. Studies have been conducted in populations reflecting the presumptive eventual clinic population including individuals who are HIV positive or who have specific medical and psychiatric disorders such as mild cognitive impairment, affective disorders, heart disease, and schizophrenia. The department is justifiably proud of the fact that faculty investigators have been leaders in studies of antidepressant pharmacology in children and adolescents. Its investigators have done some of the most extensive and systematic work in children with imipramine which for many years was the antidepressant of first choice in this population. Subsequently, departmental investigators were the first to study the pharmacokinetics and clinical pharmacology of several of the recently released antidepressants in children and adolescents including venlafaxine and nefazodone.

In addition to state of the art pharmacokinetic studies and conventional measures of efficacy, tolerability and safety, drug development research in the department has included various biochemical and physiological surrogate measures of drug effect on brain, cardiac, and immune function. The goal of such work is to better define the mechanisms of action underlying the clinical efficacy of new chemical entities. Such research also provides insight into the potential pathophysiology underlying specific psychiatric illnesses given the ability now to develop new chemical entities with highly precise and novel mechanisms of action. Such drugs serve as probes to study the physiology of these illnesses.

Another research focus has been improved understanding of the common use of polypharmacy in clinical practice. This research effort has several different arms. One arm is to survey polypharmacy in different clinical settings including primary care and subspecialities in terms of the nature and frequency of specific drug combinations and predictors of such combinations. Another is formal drug-drug interaction studies in both normal volunteers and in specific patient populations. This latter area has involved collaborative studies with several research groups at other universities in both clinical and basic science departments to first model the effects of drugs on particular sites of action and then to extend these studies into man. This line of research has focused most recently on the effects of psychiatric medications, particularly new antidepressants, on cytochrome P450 (CYP) enzymes which are responsible for the bulk of oxidative drug metabolism and hence a principle determinant of drug clearance in man. Research in this area conducted in the department has also been nationally and internationally recognized. One of the advantages of research in this area is the ability to go from in vitro prediction to in vivo reality to clinical application.

The clinical applicability of this research is immediate and appreciable. That fact has value to the residency training program. Residents are exposed to state of the art knowledge and expertise in clinical psychopharmacology, clinical trials methodology, and drug development research. Researchers in the department at CRI teach psychopharmacology course to the residents as well as supervise their clinical case work. Residents learn the basic scientific principles underlying modern clinical psychopharmacology and how to evaluate and apply research findings in the above areas to their clinical care of patients. While residents are not required to do research, they are free to take electives to gain "hands on" experience on how such research is done.

In addition to the above, the department has an unaccredited psychopharmacology fellowship which has been in existence for over 10 years. It begins in the fourth year and can extend into a fifth year. Over 70 percent of these fellows have gone into academic/research positions following the completion of their fellowship. These fellows provide further role models for first through third year residents.

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