Clinical Research Initiatives
With over ten years of experience, the Avera Research Institute has the expertise to assist the Avera Institute for Human Genetics' (AIHG) efforts to conduct clinical research. Several clinical studies are currently being conducted.
Psychiatric Pharmacogenomics: One clinical study focused on a small, defined population residing at the South Dakota Developmental Center (SDDC), which serves individuals with developmental disabilities and co-occurring psychiatric disorders. This population was selected after the state approached AIHG to help reduce individual patient’s medication burden and optimize prescription therapy to improve clinical outcomes. Interestingly, eleven of the 150 residents of SDDC utilize over $1,000 per month just for medications.
Approximately 50 residents with high numbers of medications used per month had been approached to participate in the study. Eligibility of residents was determined by the treatment team which consists of 3-4 of the following professionals: treating psychologist, behavior therapist, case manager, supervisors, counselors, dietitians, physician assistants, occupational therapists and physical therapists.
The goal of the study was to develop a process for utilizing pharmacogenomic analysis as a strategy to improve the quality of life, increase safety, reduce medication burden and enhance effectiveness of medications in people with psychiatric illnesses and developmental disabilities. Ultimately, this interdisciplinary service could be developed into a standard screening and consultation tool for healthcare providers to utilize when determining the most appropriate medication for their patients.
Attention Deficit Hyperactivity Disorder (ADHD): ADHD affects approximately 10-12 percent of school-aged children in the United States, making it one of the most common psychiatric disorders in children. The discrepancy in diagnosis and treatment of ADHD among girls may contribute to a reduced number of girls reaching adulthood with the diagnosis of ADHD. Because the prevalence of ADHD does not decline as significantly with adulthood as once thought, it is suggested a much higher incidence of undiagnosed ADHD symptoms exists among adult women. A clinical study has been designed to determine if offering relative-risk genotyping for ADHD and educating around the genetic and environmental contributions to ADHD may lead to greater healthcare acceptance in women who struggle with ADHD symptoms.
Obesity Genetics: AIHG is involved in the development of a product composed of all-natural ingredients. This nutriceutical has been tested for effectiveness in weight loss and changes in body composition in an obese population. Individuals who are at least 18 years old and have a body mass index (BMI) of at least 30 were able to participate in this trial. Results were recently published in the journal Phytomedicine.
Another clinical study involving this nutriceutical will evaluate its effectiveness in weight loss in patients taking an antipsychotic medication. With the development of second-generation antipsychotic medications comes a myriad of adverse health-related side effects including weight gain and obesity. These side effects may not only cause health-related deterioration in patients, but also compromise patients’ willingness to remain on the medications.
Obesity Genetics: Research is being done to look at weight loss reduction and cancer survivorship.