Pharmacogenetic Testing in an Outpatient Population of Patients With Depression (PGx-UPA)

Avera McKennan Hospital & University Health Center

Status: Completed

Conditions: Depression

Treatments: Other: pharmacogenetic testing

Study type: Interventional

Funder types: Other

Identifiers

NCT02497027

AIHG-1440-PGxUPA

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

83 participants in 2 patient groups

4-Week Group

Other group

Description:

Pharmacogenetic testing released to physician at 4 weeks following enrollment into study

Treatment:

Other: pharmacogenetic testing

Other: pharmacogenetic testing

12-Week Group

Other group

Description:

Pharmacogenetic testing released to physician at 12 weeks following enrollment into study

Treatment:

Other: pharmacogenetic testing

Other: pharmacogenetic testing