DepressionADOPT PGxNCT05966155

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

A study testing Pharmacogenetic testing and Clinical decisions support in people with Depression, run by Duke University at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 8 years and older
Conditions the study is for: Depression
What is being tested?: Pharmacogenetic testing and Clinical decisions support
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,572 participants
Where: 14 sitesUnited States
Study dates: 10 Aug 2021to 27 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Duke University Medical Center
Durham, North Carolina, 27710
Sanford Health
Fargo, North Dakota, 58104
University of Florida - Gainesville
Gainesville, Florida, 32610
Eskenazi Health
Indianapolis, Indiana, 46202
Indiana University
Indianapolis, Indiana, 46202
Nemours Children's Health System
Jacksonville, Florida, 32207
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Meharry Medical College
Nashville, Tennessee, 37208
Nashville General Hospital
Nashville, Tennessee, 37208
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
The Institute for Family Health
New York, New York, 10035
Nemours Children's Health System
Orlando, Florida, 32827
Nemours Children's Health System
Wilmington, Delaware, 19803

Other trials in United States

About this study

Official title: A Depression and Opioid Pragmatic Trial in Pharmacogenetics

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.

Read 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 acute and chronic pain, the challenge is finding effective therapy while minimizing adverse effects or opioid addiction (and the ensuing consequences). For depression, there are few clinically relevant predictors of successful treatment leading to multiple trials of inadequate therapy for some patients. Both opioid and antidepressant prescriptions can be guided by pharmacogenetics (PGx) data based on existing guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC).

This study is designed to evaluate the impact of pharmacogenetic testing and genotype-guided pain or anti-depressant therapy on pain control or depression symptoms in a pragmatic setting.

The rationale for examining a genotype-guided approach to acute and chronic pain management is based on the importance of CYP2D6 for the bioactivation of tramadol, codeine, and hydrocodone and data from a pilot study supporting improved pain control in intermediate and poor CYP2D6 metabolizers in the genotype-guided arm who are taking these drugs at baseline. Similarly, the rationale for examining a genotype-guided approach to depression medication therapy is based on the demonstrated role of CYP2D6 in the bio inactivation and CYP2C19 oxidation of select, commonly used SSRIs. Secondly, data from industry sponsored trials support the hypothesis of improved depression symptom control in a genotype-guided arm.

Study objectives:

Determine if genotype-guided dosing or selection of antidepressants among participants with at least 3 months of depressive symptoms who require new or revised antidepressant therapy leads to improved control of depression, compared to usual care.

Conditions: Depression
Being tested: Pharmacogenetic testing, Clinical decisions support
Keywords: Pharmacogenetic, CYP2D6, CYP2C19
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pharmacogenetic testingOther
Genetic testing of CYP2D6 and CYP2C19
Clinical decisions supportOther
Prescribing recommendations to the provider based on the pharmacogenetic testing results

Study groups in NCT05966155
Study group	Role	What they receive
Depression - Immediate PGx Testing	Experimental	Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider Receives: Other: Pharmacogenetic testing; Other: Clinical decisions support
Depression - Delayed PGx Testing	Other	Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period Receives: Other: Pharmacogenetic testing

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The 8-item PROMIS Emotional Distress Depression 8b and PROMIS Pediatric Depression Symptoms 8a questionnaire assess the extent to which participants experience depression symptoms over the past 7 days using a 5-point Likert scale. The responses to the 8 questions are converted to T-scores using the health measures assessment center scoring service. Pediatric T-scores are cross walked to adult T-scores using the cross walk published in Reeve et al 2016. Cross walked T-scores range from 37.1 to 80.9, higher scores correspond with higher levels of depression symptoms. Changes in T-scores from baseline to 3-months range from -43.8 to 43.8. Negative values of change in T-score correspond to symptom improvement, 0 corresponds to no change in depression T-scores, and positive change in depression T-scores correspond to symptom worsening at 3 months compared to baseline.
Measured: Baseline to 3 months

Secondary outcomes (7)

Change in Depression Symptomatology as Measured by Patient Health Questionnaire (PHQ-8)
The 8-item PHQ-8 Questionnaire assesses severity of depression over the past 2 weeks using a 4-point scale indicating frequency of depression symptoms: not at all, several days, more than half the days, or nearly every day. The 8 questions are converted to a score ranging from 0 (not at all for all 8 symptoms) to 24 (nearly every day for all 8 symptoms). Changes in PHQ-8 scores from baseline to 3-months range from -24 to 24 and negative values of change in PHQ-8 correspond to improvement in depression at 3 months compared to baseline.
Measured: Baseline to 3 months
Side Effect Burden
An 8-item survey was developed to assess the severity of 8 depression medication side effects, using a 4-point scale for rating severity of the side effect: none, mild, moderate, severe. The 8 questions are converted to a side effect burden score ranging from 0 (none for all 8 side effects) to 24 (severe for all 8 side effects). Higher values correspond with more side effects and with higher severity.
Measured: 3 months
Medication Non-Adherence as Measured by the Voils Medication Adherence Survey
Medication adherence level, non-adherent / adherent, derived from the Voils Medication Adherence survey. Reported as the number of participants who were non-adherent.
Measured: 3 months
Number of Participants With Depression Remission as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Remission is defined as whether or not the summed raw responses to the PROMIS emotional distress depression survey is ≤ 16, corresponding to a participant respond "rarely" or "never" to most or all questions.
Measured: 6 months
Number of Participants With Depression Remission as Measured by the Patient Health Questionnaire (PHQ-8)
The PHQ-8 scores range from 0 to 24 and remission is defined as having a PHQ-8 score of ≤ 4.
Measured: 6 months
Number of Participants With 50% Reduction in Patient Health Questionnaire (PHQ-8) Score
Measured: 3 months
Number of Participants With Drug-gene Concordance
Concordance defined as agreement between the PGx phenotype and SSRI medications reported.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202127 Apr 2024

First posted28 Jul 2023
Study start10 Aug 2021
Primary completion27 Apr 2024
Study completion27 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy
Masking: None (open label)
Enrolment: 1,572 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05966155
Sponsor's protocol ID: PRO00104948_C
Other IDs: U01HG010225
Acronym: ADOPT PGx
Status last verified: Jun 2025
First submitted: 21 Jul 2023
Last updated: 29 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hines LJ, Wilke RA, Myers R, Mathews CA, Liu M, Baye JF, Petry N, Cicali EJ, Duong BQ, Elwood E, Hulvershorn L, Nguyen K, Ramos M, Sadeghpour A, Wu RR, Williamson L, Wiisanen K, Voora D, Singh R, Blake KV, Murrough JW, Volpi S, Ginsburg GS, Horowitz CR, Orlando L, Chakraborty H, Dexter P, Johnson JA, Skaar TC, Cavallari LH, Van Driest SL, Peterson JF; IGNITE Pragmatic Trials Network. Rationale and design for a pragmatic randomized trial to assess gene-based prescribing for SSRIs in the treatment of depression. Clin Transl Sci. 2024 Jun;17(6):e13822. doi: 10.1111/cts.13822.
PubMed 38860639
Blake KV, Hines LJ, Liu M, Myers RA, Baye JF, Cavanaugh KL, Duong BQ, Hulvershorn LA, Mathews CA, Murrough JW, Orlando LA, Petry NJ, Tillman EM, Sadeghpour A, Voora D, Block SL, Cicali EJ, Clermont S, Elwood EN, Harris EC, Nguyen KA, Ramos MA, Rosenman MB, Shroff N, Shuman S, Wyatt C, Horowitz CR, Volpi S, Singh R, Rider RA, Chakraborty H, Dexter PR, Johnson JA, Skaar TC, Cavallari LH, Peterson JF; IGNITE Pragmatic Trials Network. Genotype-Guided Antidepressant Prescribing for Patients With Depression: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2610609. doi: 10.1001/jamanetworkopen.2026.10609.
PubMed 42090156

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Depression and Opioid Pragmatic Trial in Pharmacogenetics
ClinicalTrials.gov ID: NCT05966155
Acronym / sponsor ID: ADOPT PGx / PRO00104948_C
Conditions: Depression
Keywords: Pharmacogenetic, CYP2D6, CYP2C19
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,572 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Human Genome Research Institute (NHGRI), University of Florida, Vanderbilt University Medical Center, Indiana University, Icahn School of Medicine at Mount Sinai
Study start: 10 Aug 2021 (actual)
Primary completion: 27 Apr 2024 (actual)
Study completion: 27 Apr 2024 (actual)
First posted: 28 Jul 2023 (actual)
Results: Posted 29 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study is designed to evaluate the impact of pharmacogenetic testing and genotype-guided pain or anti-depressant therapy on pain control or depression symptoms in a pragmatic setting.

Study objectives:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy

Arm	Type	Receives
Depression - Immediate PGx Testing	Experimental	Other: Pharmacogenetic testing, Other: Clinical decisions supportImmediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider
Depression - Delayed PGx Testing	Other	Other: Pharmacogenetic testingDelayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period

Who may qualify

Ages: 8 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pharmacogenetic testingGenetic testing of CYP2D6 and CYP2C19	Other	Depression - Delayed PGx Testing, Depression - Immediate PGx Testing
Clinical decisions supportPrescribing recommendations to the provider based on the pharmacogenetic testing results	Other	Depression - Immediate PGx Testing

Primary outcome

Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: Baseline to 3 months
The 8-item PROMIS Emotional Distress Depression 8b and PROMIS Pediatric Depression Symptoms 8a questionnaire assess the extent to which participants experience depression symptoms over the past 7 days using a 5-point Likert scale. The responses to the 8 questions are converted to T-scores using the health measures assessment center scoring service. Pediatric T-scores are cross walked to adult T-scores using the cross walk published in Reeve et al 2016. Cross walked T-scores range from 37.1 to 80.9, higher scores correspond with higher levels of depression symptoms. Changes in T-scores from baseline to 3-months range from -43.8 to 43.8. Negative values of change in T-score correspond to symptom improvement, 0 corresponds to no change in depression T-scores, and positive change in depression T-scores correspond to symptom worsening at 3 months compared to baseline.

7 secondary outcomes

Change in Depression Symptomatology as Measured by Patient Health Questionnaire (PHQ-8)
Time frame: Baseline to 3 months
Side Effect Burden
Time frame: 3 months
Medication Non-Adherence as Measured by the Voils Medication Adherence Survey
Time frame: 3 months
Number of Participants With Depression Remission as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: 6 months
Number of Participants With Depression Remission as Measured by the Patient Health Questionnaire (PHQ-8)
Time frame: 6 months
Number of Participants With 50% Reduction in Patient Health Questionnaire (PHQ-8) Score
Time frame: 3 months
Number of Participants With Drug-gene Concordance
Time frame: 3 months

Results and safety

Results posted to the registry on 29 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Depression - Immediate PGx Testing	727	654
Depression - Delayed PGx Testing	733	653

Primary outcome: Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

Time frame: Baseline to 3 months. Mean (Standard Deviation). Unit: T-score

Measure	Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) n = 329	Depression - Delayed PGx Testing (Modified Intent to Treat, mITT) n = 320
Value	-4.3 (8.4)	-4.0 (8.1)

Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) vs Depression - Delayed PGx Testing (Modified Intent to Treat, mITT): Mean Difference (Final Values): -0.27 (95% CI -1.54 to 1.00), p = 0.677, t-test, 2 sided

Population analysed: Modified intent to treat (mITT) population consisting of participants with a CYP2C19 poor, rapid, or ultra-rapid metabolizer phenotype or a CYP2D6 poor or ultra-rapid metabolizer phenotype. All mITT participants with completed PROMIS Depression surveys at both baseline and 3 months are included. Participants with missing PROMIS depression surveys at either baseline or 3-months are excluded.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Depression - Immediate PGx Testing	0 of 727 (0%)	0 of 727 (0%)	1 of 727
Depression - Delayed PGx Testing	0 of 733 (0%)	0 of 733 (0%)	2 of 733

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38860639Hines LJ, Wilke RA, Myers R, Mathews CA, Liu M, Baye JF, Petry N, Cicali EJ, Duong BQ, Elwood E, Hulvershorn L, Nguyen K, Ramos M, Sadeghpour A, Wu RR, Williamson L, Wiisanen K, Voora D, Singh R, Blake KV, Murrough JW, Volpi S, Ginsburg GS, Horowitz CR, Orlando L, Chakraborty H, Dexter P, Johnson JA, Skaar TC, Cavallari LH, Van Driest SL, Peterson JF; IGNITE Pragmatic Trials Network. Rationale and design for a pragmatic randomized trial to assess gene-based prescribing for SSRIs in the treatment of depression. Clin Transl Sci. 2024 Jun;17(6):e13822. doi: 10.1111/cts.13822.
Derived from this study: PubMed 42090156Blake KV, Hines LJ, Liu M, Myers RA, Baye JF, Cavanaugh KL, Duong BQ, Hulvershorn LA, Mathews CA, Murrough JW, Orlando LA, Petry NJ, Tillman EM, Sadeghpour A, Voora D, Block SL, Cicali EJ, Clermont S, Elwood EN, Harris EC, Nguyen KA, Ramos MA, Rosenman MB, Shroff N, Shuman S, Wyatt C, Horowitz CR, Volpi S, Singh R, Rider RA, Chakraborty H, Dexter PR, Johnson JA, Skaar TC, Cavallari LH, Peterson JF; IGNITE Pragmatic Trials Network. Genotype-Guided Antidepressant Prescribing for Patients With Depression: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2610609. doi: 10.1001/jamanetworkopen.2026.10609.
Rationale and design for a pragmatic randomized trial to assess gene-based prescribing for SSRIs in the treatment of depressionLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hrishikesh Chakraborty study director

Duke University

Josh F. Peterson, MD principal investigator

Vanderbilt University Medical Center

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacogenetic testing and Clinical decisions support in people with Depression, run by Duke University at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05966155, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.