N/A
N=1,460
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)
Depression
Bottom Line
View on ClinicalTrials.gov: NCT05966155 ↗Enrolled (actual)
1,460
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) — -4.3; -4.0 T-score — p=0.677
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacogenetic testing (Other); Clinical decisions support (Other)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) |
-4.3; -4.0 | 0.677 |
| SECONDARY Change in Depression Symptomatology as Measured by Patient Health Questionnaire (PHQ-8) |
-3.3; -2.7 | 0.1264 |
| SECONDARY Side Effect Burden |
8.2; 7.8 | 0.3692 |
| SECONDARY Medication Non-Adherence as Measured by the Voils Medication Adherence Survey |
142; 137 | 0.8492 |
| SECONDARY Number of Participants With Depression Remission as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) |
153; 122 | 0.0246 sig |
| SECONDARY Number of Participants With Depression Remission as Measured by the Patient Health Questionnaire (PHQ-8) |
95; 65 | 0.0111 sig |
| SECONDARY Number of Participants With 50% Reduction in Patient Health Questionnaire (PHQ-8) Score |
92; 71 | 0.0776 |
| SECONDARY Number of Participants With Drug-gene Concordance |
273; 234 | 0.0014 sig |
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 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.
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
Data sourced from ClinicalTrials.gov (NCT05966155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.