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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02474680

Acronym

PGx-TIME

Enrollment

Registered

2015-06-18

Start date

2015-11-01

Completion date

2017-01-01

Last updated

2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder 1

Keywords

depression, Major Depressive Disorder, MDD, mental health, pharmacogenomics, personalized medicine, precision medicine, anti-depressants

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.

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.

Interventions

GENETICPharmacogenetic testing

Psychotropic genotyping panel

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Economic impact of pharmacogenetic testing	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026