Pharmacogenetic Testing in an Outpatient Population of Patients With Depression

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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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.

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

Conditions
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Depression

Intervention / Treatment
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* Other: pharmacogenetic testing
* 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 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

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 report released to physician at 4 weeks post enrollment<br>|
| Other: 12-Week Group<br>Pharmacogenetic testing released to physician at 12 weeks following enrollment into study | Other: pharmacogenetic testing<br>* pharmacogenetic testing report released to physician at 12 weeks post enrollment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression score | response to medication following medication recommendation guided by pharmacogenetic testing | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical utility questionnaire | This will be assessed through review of medical records and a study compliance questionnaire to be completed by the prescribing physician | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacogenetic, pharmacogenomic, depressive, mental health