Developmental DisabilitiesNCT01274065
Developing an Interdisciplinary Pharmacogenomic Treatment Approach to Reduce Medication Burden and Improve Outcomes
An observational study of Developmental Disabilities, run by Avera McKennan Hospital & University Health Center.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Developmental Disabilities
- What is being tested?
- Genetic analysis
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- To be determined by the research staff
About this study
Official title: Developing an Interdisciplinary Pharmacogenomic Treatment Approach to Reduce Medication Burden and Improve Subject Outcomes
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.
Read the 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.
- Conditions
- Developmental Disabilities
- Being tested
- Genetic analysis
- Keywords
- psychiatry, psychiatric illness, developmental disability, mental health, medication burden
- Medical subject headings
- Developmental Disabilities, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic analysisGenetic
Also called pharmacogenomics
The research team will review data following DNA sample analysis and identify variants in genes that result in impaired drug metabolism
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: Genetic analysis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startSep 2009
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Developmental DisabilitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Soundy, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274065
- Sponsor's protocol ID
- ARI-1290-Pharm
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2011
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18855611Oscarson 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.
PubMed 12747605Deeken J. The Affymetrix DMET platform and pharmacogenetics in drug development. Curr Opin Mol Ther. 2009 Jun;11(3):260-8.
PubMed 19479659de 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.
PubMed 16384813
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Interdisciplinary Pharmacogenomic Treatment Approach to Reduce Medication Burden and Improve Subject Outcomes
- ClinicalTrials.gov ID
- NCT01274065
- Acronym / sponsor ID
- ARI-1290-Pharm
- Conditions
- Developmental Disabilities
- Keywords
- psychiatry, psychiatric illness, developmental disability, mental health, medication burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychiatric illnesses | – | Genetic: Genetic analysisParticipants will reside at the South Dakota Developmental Center (SDDC), which serves a unique population of people with developmental disabilities and co-occuring psychiatric disorders. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- To be determined by the research staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic analysisAlso: pharmacogenomicsThe research team will review data following DNA sample analysis and identify variants in genes that result in impaired drug metabolism | Genetic | Psychiatric illnesses |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Background: PubMed 18855611Zhou 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.
- Background: PubMed 12747605Oscarson 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.
- Background: PubMed 19479659Deeken J. The Affymetrix DMET platform and pharmacogenetics in drug development. Curr Opin Mol Ther. 2009 Jun;11(3):260-8.
- Background: PubMed 16384813de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Soundy, MD principal investigator
Avera McKennan Hospital & University Health Center
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Disabilities, run by Avera McKennan Hospital & University Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01274065, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.