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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).
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.
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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 report released to physician at 4 weeks post enrollment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression score | response to medication following medication recommendation guided by pharmacogenetic testing | 24 weeks |
| 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 |
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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 |
|---|---|
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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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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| pharmacogenetic testing | Other | pharmacogenetic testing report released to physician at 12 weeks post enrollment |
|
| 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 |