Trial · NCT05966155
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)
NCT05966155, Not applicable, Completed, Duke University; results first posted 2025-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial). Trials, record NCT05966155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05966155
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)
- NCT number
- NCT05966155
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,572 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Depression
- Interventions
- Pharmacogenetic testing, Clinical decisions support
- First posted
- 2023-07-28
- Last updated
- 2025-06-29
- Results first posted
- 2025-06-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 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. |
| Secondary | Change in Depression Symptomatology as Measured by Patient Health Questionnaire (PHQ-8) | Baseline to 3 months | 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. |
| Secondary | Side Effect Burden | 3 months | 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. |
| Secondary | Medication Non-Adherence as Measured by the Voils Medication Adherence Survey | 3 months | Medication adherence level, non-adherent / adherent, derived from the Voils Medication Adherence survey. Reported as the number of participants who were non-adherent. |
| Secondary | Number of Participants With Depression Remission as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | 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. |
| Secondary | Number of Participants With Depression Remission as Measured by the Patient Health Questionnaire (PHQ-8) | 6 months | The PHQ-8 scores range from 0 to 24 and remission is defined as having a PHQ-8 score of ≤ 4. |
| Secondary | Number of Participants With 50% Reduction in Patient Health Questionnaire (PHQ-8) Score | 3 months | |
| Secondary | Number of Participants With Drug-gene Concordance | 3 months | Concordance defined as agreement between the PGx phenotype and SSRI medications reported. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Baseline to 3 months | 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. | T-score | MEAN |
| SECONDARY | Change in Depression Symptomatology as Measured by Patient Health Questionnaire (PHQ-8) | Baseline to 3 months | Modified ITT 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 PHQ-8 surveys at both baseline and 3 months are included. Participants with missing PHQ-8 surveys at either baseline or 3-months are excluded. | score on a scale | MEAN |
| SECONDARY | Side Effect Burden | 3 months | 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 medication side effect surveys at 3 months are included. Participants with missing side effect surveys at 3-months are excluded. | score on a scale | MEAN |
| SECONDARY | Medication Non-Adherence as Measured by the Voils Medication Adherence Survey | 3 months | 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 2 or more Voils survey questions completed at 3 months are included. Participants with fewer than 2 completed Voils survey questions are excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Depression Remission as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | 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 a completed PROMIS depression survey at 6 months are include. Participants with an incomplete PROMIS depression survey are excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Depression Remission as Measured by the Patient Health Questionnaire (PHQ-8) | 6 months | 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 a completed PHQ-8 survey at 6 months are include. Participants with an incomplete PHQ-8 survey are excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With 50% Reduction in Patient Health Questionnaire (PHQ-8) Score | 3 months | 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 a completed PHQ-8 survey at baseline and 3 months are included. Participants with an incomplete PHQ-8 survey at either baseline or 3 months are excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Drug-gene Concordance | 3 months | 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 a completed medication review at 3 months are included. Participants without a medication review at 3 months are excluded. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) | -4.3 | Standard Deviation 8.4 | T-score | |
| Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Depression - Delayed PGx Testing (Modified Intent to Treat, mITT) | -4.0 | Standard Deviation 8.1 | T-score | |
| Change in Depression Symptomatology as Measured by Patient Health Questionnaire (PHQ-8) | Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) | -3.3 | Standard Deviation 5.2 | score on a scale | |
| Change in Depression Symptomatology as Measured by Patient Health Questionnaire (PHQ-8) | Depression - Delayed PGx Testing (Modified Intent to Treat, mITT) | -2.7 | Standard Deviation 4.8 | score on a scale | |
| Side Effect Burden | Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) | 8.2 | Standard Deviation 4.3 | score on a scale | |
| Side Effect Burden | Depression - Delayed PGx Testing (Modified Intent to Treat, mITT) | 7.8 | Standard Deviation 4.5 | score on a scale | |
| Medication Non-Adherence as Measured by the Voils Medication Adherence Survey | Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) | 142 | Participants | ||
| Medication Non-Adherence as Measured by the Voils Medication Adherence Survey | Depression - Delayed PGx Testing (Modified Intent to Treat, mITT) | 137 | Participants | ||
| Number of Participants With Depression Remission as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) | 153 | Participants | ||
| Number of Participants With Depression Remission as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Depression - Delayed PGx Testing (Modified Intent to Treat, mITT) | 122 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Depression - Immediate PGx Testing | 727 | |
| Overall Study | STARTED | Depression - Delayed PGx Testing | 733 | |
| Overall Study | COMPLETED | Depression - Immediate PGx Testing | 654 | |
| Overall Study | COMPLETED | Depression - Delayed PGx Testing | 653 | |
| Overall Study | NOT COMPLETED | Depression - Immediate PGx Testing | 73 | |
| Overall Study | NOT COMPLETED | Depression - Delayed PGx Testing | 80 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Depression - Immediate PGx Testing | 1 | 727 |
| Total, all-cause mortality | Depression - Delayed PGx Testing | 2 | 733 |
| Total, other adverse events | Depression - Immediate PGx Testing | 0 | 727 |
| Total, other adverse events | Depression - Delayed PGx Testing | 0 | 733 |
| Total, serious adverse events | Depression - Immediate PGx Testing | 0 | 727 |
| Total, serious adverse events | Depression - Delayed PGx Testing | 0 | 733 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HG010225 | The IGNITE II CC: Engagement, Coordination, Demonstration, and Dissemination | WYATT, CHRISTINA M; CHAKRABORTY, HRISHIKESH | DUKE UNIVERSITY | NATIONAL HUMAN GENOME RESEARCH INSTITUTE | 2018 to 2024 |
Source NIH RePORTER
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) vs Depression - Delayed PGx Testing (Modified Intent to Treat, mITT): Number of Participants With 50% Reduction in Patient Health Questionnaire (PHQ-8) Score | Trial comparisons |
Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) vs Depression - Delayed PGx Testing (Modified Intent to Treat, mITT): Number of Participants With Depression Remission as Measured by the Patient Health Questionnaire (PHQ-8) | Trial comparisons |
Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) vs Depression - Delayed PGx Testing (Modified Intent to Treat, mITT): Medication Non-Adherence as Measured by the Voils Medication Adherence Survey | Trial comparisons |
Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) vs Depression - Delayed PGx Testing (Modified Intent to Treat, mITT): Number of Participants With Depression Remission as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Trial comparisons |
| Depression - Immediate PGx Testing vs Depression - Delayed PGx Testing: deaths from any cause | Trial comparisons |
| Depression - Immediate PGx Testing (Modified Intent to Treat, mITT) vs Depression - Delayed PGx Testing (Modified Intent to Treat, mITT): Number of Participants With Drug-gene Concordance | Trial comparisons |
| Depression - Immediate PGx Testing vs Depression - Delayed PGx Testing: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05966155
GET https://conductscience.org/api/trials/v1/NCT05966155/registered