Pharmacogenetic Testing in an Outpatient Population of Patients With Depression

Avera McKennan Hospital & University Health Center83 enrolled

Overview

This is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS). Prospective data will be collected on all subjects until study completion at 24-25 weeks post enrollment. Claims data may be reviewed per pay, if such data are readily available in a timely manner.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Depression

Interventions

pharmacogenetic testingOTHER

pharmacogenetic testing report released to physician at 4 weeks post enrollment

pharmacogenetic testingOTHER

pharmacogenetic testing report released to physician at 12 weeks post enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Current primary or secondary diagnosis of Major Depressive Disorder or Depressive Disorder Not Otherwise Specified * Have moderate to severe depression as identified by PHQ-9 scoring of 10 or greater * Taking or be newly prescribed an anti-depressant or anti-psychotic medication * Able to provide informed consent * Prescribing physician practices at the Avera Medical Group University Psychiatry Associates clinic in Sioux Falls, SD Exclusion Criteria: * Pregnant or breastfeeding * Active and/or unstable diagnosis of substance abuse, excluding nicotine * Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schizoaffective disorder, or personality disorder

Locations (1)

Avera McKennan Hospital & University Health Center

Sioux Falls, South Dakota, United States

Outcomes

Primary Outcomes

Depression score

response to medication following medication recommendation guided by pharmacogenetic testing

Time frame: 24 weeks

Secondary Outcomes

Clinical utility questionnaire

This will be assessed through review of medical records and a study compliance questionnaire to be completed by the prescribing physician

Time frame: 24 weeks

Data from ClinicalTrials.gov

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