Developing an Interdisciplinary Pharmacogenomic Treatment Approach to Reduce Medication Burden and Improve Outcomes

Sponsor
Avera McKennan Hospital & University Health Center (Other)
Overall Status
Completed
CT.gov ID
NCT01274065
Collaborator
(none)
38
62

Study Details

Study Description

Brief Summary

There is no common rule as to how a drug will affect patients. This is due to the effect specific DNA sequences of genes have on drug response, by the effect they have on how medications are metabolized. The primary objective of this research is to optimize medication therapy and to reduce the number of medications used, specifically medications for people with developmental disabilities and co-occuring psychiatric illnesses.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Genetic analysis

Detailed Description

The primary goal of this study is to develop a process for utilizing pharmacogenomic analysis as a strategy to improve the quality of life, safety, decrease medication burden, and enhance the effectiveness of medications in people with psychiatric illnesses and developmental disabilities. Ultimately, this inter-disciplinary 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.

Study Design

Study Type:
Observational
Actual Enrollment :
38 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Developing an Interdisciplinary Pharmacogenomic Treatment Approach to Reduce Medication Burden and Improve Subject Outcomes
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Psychiatric illnesses

Participants will reside at the South Dakota Developmental Center (SDDC), which serves a unique population of people with developmental disabilities and co-occuring psychiatric disorders.

Genetic: Genetic analysis
The research team will review data following DNA sample analysis and identify variants in genes that result in impaired drug metabolism
Other Names:
  • pharmacogenomics
  • Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      13 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Current resident of the South Dakota Developmental Center (SDDC)

      • Currently taking a high number of medications per month

      • Eligibility of the subjects will be determined by the treatment team which consists of 3-4 of the following individuals: treating psychologist, behavior therapist, case manager, supervisors, counselors, dietitians, physician assistants, occupational therapists, and physical therapists

      Exclusion Criteria:
      • To be determined by the research staff

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Avera McKennan Hospital & University Health Center

      Investigators

      • Principal Investigator: Timothy Soundy, MD, Avera McKennan Hospital & University Health Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Avera McKennan Hospital & University Health Center
      ClinicalTrials.gov Identifier:
      NCT01274065
      Other Study ID Numbers:
      • ARI-1290-Pharm
      First Posted:
      Jan 11, 2011
      Last Update Posted:
      Jan 14, 2015
      Last Verified:
      Jan 1, 2015
      Keywords provided by Avera McKennan Hospital & University Health Center
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Jan 14, 2015