A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)

Completed · Not applicable

Conditions studied: Depression

In brief

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 Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial. Participants can enroll in only one of the three trials. All three trials were registered on ClinicalTrials.gov under NCT04445792. In July 2023 each of the three treatment trials was registered under a separate NCT# and NCT04445792 was converted to a screening record per recent guidance on master protocol research programs (MPRPs). This record is specific to the Depression Trial within the ADOPT-PGx protocol. The Depression Trial is a prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype-guided anti-depressant therapy will reduce depression symptoms in participants who's body processes some anti-depressants faster or slower than normal.

Key facts

Study ID

NCT05966155

Run by

Duke University

People needed

1572

Starts

2021-08-10

Expected to finish

2024-04-27

Last updated by the study team

2025-06-29

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nemours Children's Health System — Wilmington, Delaware, United States
• University of Florida - Gainesville — Gainesville, Florida, United States
• Nemours Children's Health System — Jacksonville, Florida, United States
• University of Florida - Jacksonville — Jacksonville, Florida, United States
• Nemours Children's Health System — Orlando, Florida, United States
• Eskenazi Health — Indianapolis, Indiana, United States
• Indiana University — Indianapolis, Indiana, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• The Institute for Family Health — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Sanford Health — Fargo, North Dakota, United States
• Meharry Medical College — Nashville, Tennessee, United States
• Nashville General Hospital — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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