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| Name | Class |
|---|---|
| Pine Rest Christian Mental Health Services | OTHER |
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Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive report improves outcomes when compared with standard treatment without the availability of genetic information.
This study is designed to evaluate the clinical impact of pharmacogenetic (PGx)-directed treatment, as guided by interpretive, algorithmic report in the Pine Rest outpatient behavioral health clinics. The PGx algorithm utilized in this study is the foundation of a novel method of interpreting genetic testing results and reports them in a rapidly delivered format that provides enhanced guidance to psychiatrists in their selection of antidepressant medications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | Active Comparator |
| |
| Pharmacogenetic guided treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GeneSightRx | Behavioral | Multi-genetic pharmacogenomic panel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Score reduction | Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment. | 8 weeks |
| Side effect reduction | Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depression response or remission | Percentage of subjects who respond (≥50% decrease in HAMD17 and QIDS-CR* rating) or remit (HAMD17< 7 and QIDS-CR rating < 5) with PGx-guided treatment. | 8 weeks |
| Time to response/remission of depressive symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Furmaga, PharmD | Pine Rest Mental Health Service | Principal Investigator |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual |
| Behavioral |
Treatment as usual |
|
Time to response/remission of depressive symptoms.
| 8 weeks |
| Medication change | Number of subjects who changed their baseline antidepressant medication regimens. | 8 weeks |
| Health care clinical cost | Health care clinical cost (defined by mental health resource utilization). | 8 weeks |
| Report availability | Percent of time that the PGx interpretive report is completed and available to the psychiatrist/nurse practitioner prior to seeing the patient. | 8 weeks |
| Medication Choice | Proportion of time that the psychiatrist/nurse practitioner prescribed a medication that was recommended by the algorithm. | 8 weeks |
| Physician satisfaction | Physician satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey). | 8 weeks |
| Patient Satisfaction | Patient satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey). | 8 weeks |