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

May 2, 2017 updated by: Avera McKennan Hospital & University Health Center
This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Avera Institute for Human Genetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression scores
Time Frame: 12 months
Compare depression scores at baseline and following pharmacogenetic-guided medication recommendation
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avera McKennan Hospital & University Health Center

Investigators

  • Principal Investigator: Matthew Stanely, MD, Avera McKennan Hospital & University Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIHG-1420-PGxTIME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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