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Trial record 17 of 1104 for:    pharmacogenomics OR pharmacogenetics

Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes (PGx-TIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02474680
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

Brief Summary:
This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants.

Condition or disease Intervention/treatment
Major Depressive Disorder 1 Genetic: Pharmacogenetic testing

Detailed Description:
This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants. Retrospective and prospective data will be collected on all subjects before and after pharmacogenetic recommendations have been made. Retrospective data will be collected for the previous 12 months before pharmacogenetic recommendations are made and prospective data will be collected for 12 months after pharmacogenomic recommendations have been made.

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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Group/Cohort Intervention/treatment
Care Coordination Group
Patients participating in the Avera Care Coordination Program for Intervention 'Pharmacogenetic testing'
Genetic: Pharmacogenetic testing
Psychotropic genotyping panel




Primary Outcome Measures :
  1. Depression scores [ Time Frame: 12 months ]
    Compare depression scores at baseline and following pharmacogenetic-guided medication recommendation


Secondary Outcome Measures :
  1. Economic impact of pharmacogenetic testing [ Time Frame: 12 months ]
    Data from patients' insurance provider will be compared pre- and post-pharmacogenetic testing. Such data may include hospitalizations, clinic visits, ER visits, medication expenses, etc.


Biospecimen Retention:   Samples With DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants must be enrolled in the Avera Care Coordination Program and have insurance coverage through the Avera Health Plans
Criteria

Inclusion Criteria:

  • Must be taking either an anti-depressant or an anti-psychotic medication
  • Must provide informed consent
  • Must have Avera Health Plans insurance coverage
  • Must have three months of participation in the Avera Care Coordination Program

Exclusion Criteria:

  • Must not be pregnant or breastfeeding
  • Must not have an active and/or unstable diagnosis of substance abuse
  • Must not have a primary diagnosis of dementia, bulimia, or anorexia nervosa disorder
  • Must not have had a previous pharmacogenetic evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474680


Locations
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United States, South Dakota
Avera Institute for Human Genetics
Sioux Falls, South Dakota, United States, 57108
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
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Principal Investigator: Matthew Stanely, MD Avera McKennan Hospital & University Health Center

Additional Information:
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Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT02474680     History of Changes
Other Study ID Numbers: AIHG-1420-PGxTIME
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by Avera McKennan Hospital & University Health Center:
depression
Major Depressive Disorder
MDD
mental health
pharmacogenomics
personalized medicine
precision medicine
anti-depressants
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms