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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01274065
First received: January 7, 2011
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Developmental Disabilities
Genetic: Genetic analysis
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing an Interdisciplinary Pharmacogenomic Treatment Approach to Reduce Medication Burden and Improve Subject Outcomes

Resource links provided by NLM:


Further study details as provided by Avera McKennan Hospital & University Health Center:

Biospecimen Retention:   Samples With DNA

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Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: pharmacogenomics

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274065

Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
Principal Investigator: Timothy Soundy, MD Avera McKennan Hospital & University Health Center
  More Information

Publications:
Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01274065     History of Changes
Other Study ID Numbers: ARI-1290-Pharm
Study First Received: January 7, 2011
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
psychiatry
psychiatric illness
developmental disability
mental health
medication burden

Additional relevant MeSH terms:
Developmental Disabilities
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014