A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial) (ADOPT PGx)
Depression
About this trial
This is an interventional treatment trial for Depression focused on measuring Pharmacogenetic, CYP2D6, CYP2C19
Eligibility Criteria
Inclusion Criteria: Depression Trial Age ≥ 8 years English speaking or Spanish speaking Patients followed at psychiatry clinics or primary care clinics at an enrolling site (such as, but not limited to, Internal Medicine, Family Medicine, or Pediatrics) Documentation of depression and/or provider report of depression Evidence of depressive symptoms for at least 3 months based on patient interview or documentation in electronic health records Recent initiation of SSRI therapy, recent revised SSRI therapy, or anticipated need for revised or new SSRI therapy per health care provider Exclusion Criteria Trial-wide: Life expectancy less than 12 months Are too cognitively impaired to provide informed consent and/or complete study protocol Are institutionalized or too ill to participate (i.e. mental or nursing home facility or incarcerated) Have a history of allogeneic stem cell transplant or liver transplant People with prior clinical pharmacogenetic test results for genes relevant for the study in which they will enroll (CYP2D6 for the pain studies and CYP2D6 or CYP2C19 for depression) or already enrolled in an ADOPT PGx trial Depression Trial Plan to move out of the area within 6 months of enrollment Have active psychosis or diagnosed psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, psychotic depression, substance induced psychosis, schizophreniform disorder) Have dementia or other neurocognitive disorders due to any cause, such as Alzheimer's disease, vascular/subcortical, lewy body disease, frontotemporal lobar degeneration Have cognitive developmental delay and/or cognitive disability, including autism spectrum disorders (Note: ADHD is not an exclusion criteria) Has a seizure disorder Have bipolar disorder
Sites / Locations
- Nemours Children's Health System
- University of Florida - Gainesville
- Nemours Children's Health System
- University of Florida - Jacksonville
- Nemours Children's Health System
- Eskenazi Health
- Indiana University
- Icahn School of Medicine at Mount Sinai
- The Institute for Family Health
- Duke University Medical Center
- Sanford Health
- Meharry Medical College
- Nashville General Hospital
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Depression - Immediate PGx Testing
Depression - Delayed PGx Testing
Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider
Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period