A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)
Public ClinicalTrials.gov record NCT05966155. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Depression and Opioid Pragmatic Trial in Pharmacogenetics
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05966155
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,572 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 10, 2021 (Actual)
- Primary completion
- Apr 27, 2024 (Actual)
- Completion
- Apr 27, 2024 (Actual)
- Last update posted
- Jun 29, 2025
2021 – 2024
United States locations
- U.S. sites
- 14
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nemours Children's Health System | Wilmington | Delaware | 19803 | — |
| University of Florida - Gainesville | Gainesville | Florida | 32610 | — |
| Nemours Children's Health System | Jacksonville | Florida | 32207 | — |
| University of Florida - Jacksonville | Jacksonville | Florida | 32209 | — |
| Nemours Children's Health System | Orlando | Florida | 32827 | — |
| Eskenazi Health | Indianapolis | Indiana | 46202 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| The Institute for Family Health | New York | New York | 10035 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Sanford Health | Fargo | North Dakota | 58104 | — |
| Meharry Medical College | Nashville | Tennessee | 37208 | — |
| Nashville General Hospital | Nashville | Tennessee | 37208 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05966155, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 29, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05966155 live on ClinicalTrials.gov.