Status:
COMPLETED
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Human Genome Research Institute (NHGRI)
University of Florida
Conditions:
Depression
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
This study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design. The three trials are the ...
Detailed Description
Pain and depression are conditions that impact substantial proportions of the US population. Finding safe and effective drug therapies for both conditions is challenging. In the case of treatment for ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2024
Estimated Enrollment :
1572 Patients enrolled
Trial Details
Trial ID
NCT05966155
Start Date
August 10 2021
End Date
April 27 2024
Last Update
June 29 2025
Active Locations (14)
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1
Nemours Children's Health System
Wilmington, Delaware, United States, 19803
2
University of Florida - Gainesville
Gainesville, Florida, United States, 32610
3
Nemours Children's Health System
Jacksonville, Florida, United States, 32207
4
University of Florida - Jacksonville
Jacksonville, Florida, United States, 32209