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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-Week Group | Other | Pharmacogenetic testing released to physician at 4 weeks following enrollment into study |
|
| 12-Week Group | Other | Pharmacogenetic testing released to physician at 12 weeks following enrollment into study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacogenetic testing | Other | pharmacogenetic testing for anti-depressant/anti-psychotic medications |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Stanley, MD | Avera McKennan Hospital & University Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avera McKennan Hospital & University Health Center | Sioux Falls | South Dakota | 57105 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D001519 |
| Behavior |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |