Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis (PGX-AMG)

Avera McKennan Hospital & University Health Center

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Other: pharmacogenetic testing

Study type: Interventional

Funder types: Other

Identifiers

NCT02443584

AIHG-1430-PGxAMG

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

Mental illness affects one in four adults in the United States; approximately 61.5 million Americans experience mental illness in a given year. According to the National Alliance for the Mentally Ill, the impact of serious mental illness costs Americans $193.2 billion in lost earnings per year. In addition, mental illness patients have an increased risk of having chronic medical conditions, leading to increased costs and emergency service utilization for those conditions. In addition to substantial costs, patients with psychiatric illness are difficult to treat. More than two-thirds of patients with depression do not respond to first line therapy. Treatment often involves numerous trials of individual agents and combinations of medications in order to achieve optimal response. Pharmacogenetic testing is being used in more settings to guide treatment decisions.

Enrollment: 84 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

Exclusion criteria

• Pregnant or breastfeeding
• Active and/or unstable diagnosis of substance abuse, excluding nicotine
• Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schioaffective disorder, or personality disorder

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 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

12-Week Group

Other group

Description:

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

Treatment:

Other: pharmacogenetic testing