NCT01274065

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

5.2 years

First QC Date

January 7, 2011

Last Update Submit

January 13, 2015

Conditions

Developmental Disabilities

Keywords

psychiatrypsychiatric illnessdevelopmental disabilitymental healthmedication burden

Study Arms (1)

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

Interventions

Genetic analysisGENETIC

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

Also known as: pharmacogenomics
Psychiatric illnesses

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • To be determined by the research staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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. doi: 10.2174/138920008786049302.

    PMID: 18855611BACKGROUND

  • Oscarson M. Pharmacogenetics of drug metabolising enzymes: importance for personalised medicine. Clin Chem Lab Med. 2003 Apr;41(4):573-80. doi: 10.1515/CCLM.2003.087.

    PMID: 12747605BACKGROUND

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

    PMID: 19479659BACKGROUND

  • 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. doi: 10.1176/appi.psy.47.1.75.

    PMID: 16384813BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Developmental DisabilitiesMental DisordersPsychological Well-Being

Interventions

Genetic TestingPharmacogenomic Testing

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Timothy Soundy, MD

    Avera McKennan Hospital & University Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 11, 2011

Study Start

September 1, 2009

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 14, 2015

Record last verified: 2015-01