Depression
Conditions
Keywords
GeneSight, Assurex, AssureRx
Brief summary
Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive report improves outcomes when compared with standard treatment without the availability of genetic information.
Detailed description
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
Interventions
BEHAVIORALGeneSightRx
Multi-genetic pharmacogenomic panel
BEHAVIORALTreatment as usual
Treatment as usual
Sponsors
Pine Rest Christian Mental Health Services
Assurex Health Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Major Depressive Disorder (296.2, 296.3) or Depressive Disorder NOS (311.0) by a board certified psychiatrist. * The patient is referred to the study by their treating psychiatrist or nurse practitioner who is approved by the study investigators to make subject referrals to the study. * The patient is an outpatient and not in imminent need of inpatient hospitalization for medical or psychiatric reasons. * Patient's baseline 17-Item Hamilton Depression (HAMD17) Rating score is \>14. * Provide a copy of a physical exam report performed within 6 months prior to study enrollment or undergo a physical exam by either their personal physician, a physician who is a subinvestigator on the study, or a study-contracted physician assistant in internal medicine. * Undergo a medical history that includes a review of major organ systems by either their treating clinician, a subinvestigator physician, or a study-contracted physician assistant in internal medicine. * The patient has signed the study informed consent form.
Exclusion criteria
* Serious medical illness (as ascertained via inclusion criteria 6 and 7, above). * Diagnosis of a Bipolar Disorder. * Diagnosis of Schizophrenia or Schizoaffective disorder. * Evidence from history, baseline urine drug screen, and/or psychiatric interview of active abuse of alcohol and/or other drugs of abuse within 6 months prior to study enrollment. Patients who occasionally use marijuana may still be eligible if it is determined through psychiatric interview that the level of use does not qualify as abuse, dependence, or addiction. Patients testing positive for opioids or benzodiazepines are eligible if there is no evidence of abuse and it is determined that they are taking opioid analgesics or a benzodiazepine that is prescribed by a licensed prescriber for a medical or psychiatric indication. * History of prior pharmacogenomic testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Score reduction | 8 weeks | Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment. |
| Side effect reduction | 8 weeks | Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication change | 8 weeks | Number of subjects who changed their baseline antidepressant medication regimens. |
| Health care clinical cost | 8 weeks | Health care clinical cost (defined by mental health resource utilization). |
| Report availability | 8 weeks | Percent of time that the PGx interpretive report is completed and available to the psychiatrist/nurse practitioner prior to seeing the patient. |
| Depression response or remission | 8 weeks | 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. |
| Physician satisfaction | 8 weeks | Physician satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey). |
| Patient Satisfaction | 8 weeks | Patient satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey). |
| Medication Choice | 8 weeks | Proportion of time that the psychiatrist/nurse practitioner prescribed a medication that was recommended by the algorithm. |
| Time to response/remission of depressive symptoms. | 8 weeks | Time to response/remission of depressive symptoms. |
Outcome results
None listed