Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Pharmacogenetic Testing in an Outpatient Population of Patients With Major Depressive Disorder or Depressive Disorder Not Otherwise Specified With Avera Medical Group Clinics

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Other: pharmacogenetic testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 4-Week Group<br>Pharmacogenetic testing released to physician at 4 weeks following enrollment into study | Other: pharmacogenetic testing<br>* pharmacogenetic testing for anti-depressant/anti-psychotic medications<br>|
| Other: 12-Week Group<br>Pharmacogenetic testing released to physician at 12 weeks following enrollment into study | Other: pharmacogenetic testing<br>* pharmacogenetic testing for anti-depressant/anti-psychotic medications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes (response to medication following medication recommendation guided by pharmacogenetic testing) | response to medication following medication recommendation guided by pharmacogenetic testing | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical utility (Utilization by physicians in following medication recommendations guided by pharmacogenetic testing) | Utilization by physicians in following medication recommendations guided by pharmacogenetic testing | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, pharmacogenetics, pharmacogenomics, major depressive disorder, genetics, anti-depressants