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

Developmental Disabilities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274065
• Other study ID #: ARI-1290-Pharm
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2011
• Last updated: January 13, 2015
• Start date: September 2009
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Developmental Disabilities

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center

References & Publications (4)

de Leon J, Armstrong SC, Cozza KL. Clinical guidelines for psychiatrists for the use of pharmacogenetic testing for CYP450 2D6 and CYP450 2C19. Psychosomatics. 2006 Jan-Feb;47(1):75-85. Review. — View Citation

Deeken J. The Affymetrix DMET platform and pharmacogenetics in drug development. Curr Opin Mol Ther. 2009 Jun;11(3):260-8. Review. — View Citation

Oscarson M. Pharmacogenetics of drug metabolising enzymes: importance for personalised medicine. Clin Chem Lab Med. 2003 Apr;41(4):573-80. Review. — View Citation

Zhou SF, Di YM, Chan E, Du YM, Chow VD, Xue CC, Lai X, Wang JC, Li CG, Tian M, Duan W. Clinical pharmacogenetics and potential application in personalized medicine. Curr Drug Metab. 2008 Oct;9(8):738-84. Review. — View Citation