Trial · NCT04445792
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center)
NCT04445792, Not applicable, Completed, Duke University; results first posted 2025-01-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center). Trials, record NCT04445792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04445792
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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 (DCRI Coordinating Center)
- NCT number
- NCT04445792
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 4,284 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Depression, Acute Pain, Chronic Pain
- Interventions
- Pharmacogenetic testing, Clinical decisions support
- First posted
- 2020-06-24
- Last updated
- 2026-03-25
- Results first posted
- 2025-01-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record) | Up to 3 years | Potential participants identified for the Acute Pain, Chronic Pain, and Depression Trials through EHR. |
| Primary | Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials | Up to 3 years | Individuals who were screened to be in the Acute Pain, Chronic Pain and Depression Trials. |
| Primary | Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials | Up to 3 years | Individuals who were randomized to be in the Acute Pain, Chronic Pain and Depression Trials. |
| Secondary | Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for pain interference assesses the extent to which participants experience interference with daily activities over the past 7 days using a 5-point Likert scale. The pain interference subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 41.1 to 76.3. Higher scores reflect greater pain interference. |
| Secondary | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for physical functioning assesses a participants physical functioning over the past 7 days using a 5-point Likert scale. The physical functioning sub scale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables. T-scores range from 21.0 to 59.0. Higher T-scores reflect higher levels of physical functioning. |
| Secondary | Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for sleep disturbance assesses the extent to which participants experience sleep disturbance related symptoms sleep over the past 7 days using a 5-point Likert scale. The sleep disturbance subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMNIS conversion tables, ranging from 31.7 to 76.1. Higher scores reflect higher levels of sleep disturbance. |
| Secondary | Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for ability to participate in social roles and activities assesses the extent to which participants are able to participant in different social roles and activities over the past 7 days using a 5-point Likert scale. The ability to participant in social roles and activities subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 26.7 to 65.0 with higher values corresponding to a higher ability to participant in social roles and activities. |
| Secondary | Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for fatigue assesses the extent to which participants experience fatigue-related symptoms over the past 7 days using a 5-point Likert scale. The fatigue subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater fatigue symptoms. |
| Secondary | Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS subscale for anxiety assesses the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale. The anxiety subscale provides a raw score, ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater anxiety. |
| Secondary | Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | The 6-item PROMIS 43 subscale for depression assesses the extent to which participants experience depressive symptoms over the past 7 days using a 5-point Likert scale. The depression subscale provides a raw sore ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 38.4 to 80.3. Higher T-scores reflect greater depression. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record) | Up to 3 years | Individuals who were prescreened. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials | Up to 3 years | Individuals who were screened for the Acute Pain, Chronic Pain, and Depression Trials. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials | Up to 3 years | Participants who were consented to the Acute Pain, Chronic Pain, and Depression Trials. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | Randomized population with completed 6 month survey. | T-score | MEAN |
| SECONDARY | Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | Randomized population with completed 6 month survey. | T-score | MEAN |
| SECONDARY | Sleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | Randomized population with completed 6 month survey. | T-score | MEAN |
| SECONDARY | Ability to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | Randomized population with completed 6 month survey. | T-score | MEAN |
| SECONDARY | Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | Randomized population with completed 6 month survey. | T-score | MEAN |
| SECONDARY | Anxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | Randomized population with completed 6 month survey. | T-score | MEAN |
| SECONDARY | Depression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | 6 months | Randomized population with completed 6 month survey. | T-score | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record) | Individuals Identified as Potential Participants Through EHR | 17,496 | Participants | ||
| Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials | Acute Pain, Chronic Pain, and Depression Trial Participants | 4,285 | Participants | ||
| Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials | Acute Pain, Chronic Pain, and Depression Trial Participants | 4110 | Participants | ||
| Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Acute Pain - Immediate PGx Testing | 51.0 | Standard Deviation 9.4 | T-score | |
| Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Acute Pain - Delayed PGx Testing | 50.9 | Standard Deviation 9.6 | T-score | |
| Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Chronic Pain - Immediate PGx Testing | 62.4 | Standard Deviation 8.4 | T-score | |
| Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Chronic Pain - Delayed PGx Testing | 62.2 | Standard Deviation 8.6 | T-score | |
| Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Depression - Immediate PGx Testing | 51.7 | Standard Deviation 10.9 | T-score | |
| Pain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Depression - Delayed PGx Testing | 51.6 | Standard Deviation 11.2 | T-score | |
| Physical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | Acute Pain - Immediate PGx Testing | 44.9 | Standard Deviation 9.7 | T-score |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acute Pain, Chronic Pain, and Depression Trial Participants | 4,110 | |
| Overall Study | COMPLETED | Acute Pain, Chronic Pain, and Depression Trial Participants | 3,502 | |
| Overall Study | NOT COMPLETED | Acute Pain, Chronic Pain, and Depression Trial Participants | 608 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Panic Attack due to sample blood draw | Injury, poisoning and procedural complications | Immediate Pharmacogenetics (PGx) Guided Therapy | 1 | 2,550 | |
| other | Panic Attack due to sample blood draw | Injury, poisoning and procedural complications | Delayed Pharmacogenetics (PGx) Testing | 0 | 2,550 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Immediate Pharmacogenetics (PGx) Guided Therapy | 5 | 2,055 |
| Total, all-cause mortality | Delayed Pharmacogenetics (PGx) Testing | 7 | 2,055 |
| Total, other adverse events | Immediate Pharmacogenetics (PGx) Guided Therapy | 1 | 2,550 |
| Total, other adverse events | Delayed Pharmacogenetics (PGx) Testing | 0 | 2,550 |
| Total, serious adverse events | Immediate Pharmacogenetics (PGx) Guided Therapy | 0 | 2,550 |
| Total, serious adverse events | Delayed Pharmacogenetics (PGx) Testing | 0 | 2,550 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Immediate Pharmacogenetics (PGx) Guided Therapy vs Delayed Pharmacogenetics (PGx) Testing: deaths from any cause | Trial comparisons |
| Immediate Pharmacogenetics (PGx) Guided Therapy vs Delayed Pharmacogenetics (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/NCT04445792
GET https://conductscience.org/api/trials/v1/NCT04445792/results?page=2