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Completed

NCT Number: NCT02474680

Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes

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

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Key information

Conditions

Major Depressive Disorder 1 Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Avera Institute for Human Genetics

Sioux Falls, South Dakota, 57108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacogenetic testing

Genetic

Psychotropic genotyping panel

Primary outcomes

  1. Depression scores

    Time frame: 12 months

    Compare depression scores at baseline and following pharmacogenetic-guided medication recommendation

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Avera McKennan Hospital & University Health Center

Other

Registry information

Acronym: PGx-TIME

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 18, 2015
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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