Gene test trial aims to personalize pain and depression care
NCT ID NCT04445792
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether genetic testing can help doctors choose better medicines for depression, acute pain, and chronic pain. Over 4,000 people were screened to join one of three trials. The goal was to see if matching drugs to a person's genes improves outcomes compared to standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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4,284 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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May 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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8 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Acute Pain * Age ≥ 8 years * English speaking or Spanish speaking * Elective/planned surgery types with planned or anticipated to be treated with tramadol, hydrocodone, or codeine pain management at an enrolling site, which may include orthopedic surgeries (e.g. arthroplasty, spine, etc.), open abdominal surgery, or cardiothoracic surgery and others Chronic Pain * Age ≥ 18 years * English speaking or Spanish speaking * Seen at primary care clinics (such as, but not limited to, Internal Medicine, Family Medicine or Pediatrics) or patients seen in pain-relevant specialty clinics * History of pain for at least the last 3 months * Currently treated or being considered for treatment with tramadol, hydrocodone, or codeine to improve pain management Depression * 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 Acute Pain * Undergoing a laparoscopic surgery * Receiving chronic opioid therapy, defined as use of opioids on most days for \>3 months Chronic Pain * Plan to move out of the area within 6 months of enrollment * Undergoing treatment for an active cancer diagnosis * Currently taking daily opioids other than tramadol, codeine or hydrocodone Depression * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Eskenazi Health
Indianapolis, Indiana, 46202, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Indiana University
Indianapolis, Indiana, 46202, United States
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Meharry Medical College
Nashville, Tennessee, 37208, United States
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Nashville General Hospital
Nashville, Tennessee, 37208, United States
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Nemours Children's Health System
Wilmington, Delaware, 19803, United States
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Nemours Children's Health System
Jacksonville, Florida, 32207, United States
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Nemours Children's Health System
Orlando, Florida, 32827, United States
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Sanford Health
Fargo, North Dakota, 58104, United States
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The Institute for Family Health
New York, New York, 10035, United States
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University of Florida - Gainesville
Gainesville, Florida, 32610, United States
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University of Florida - Jacksonville
Jacksonville, Florida, 32209, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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