A Depression and Opioid Pragmatic Trial in Pharmacogenetics

Trial tests genetic testing to guide pain and depression medication

NCT: NCT04445792 · Status: COMPLETED · Phase: N/A · Sponsor: Duke University · Started: 2021-02-24 · Est. Completion: 2024-05-10

Plain English Summary

A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center) is a Not Applicable clinical trial sponsored by Duke University studying Depression, Acute Pain, Chronic Pain. This trial investigates if genetic testing can help doctors choose the best pain or depression medication for patients. It is for individuals experiencing acute pain after surgery, chronic pain, or depression. Participants will be randomly assigned to receive genetic testing immediately to guide treatment or have testing delayed by 6 months. Standard care for pain or depression management is the alternative to immediate genetic-guided treatment. The trial aims to enroll 4284 participants.

Official Summary

This is a Master Protocol Screening record. 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. Each trial is listed individually on clinicaltrials.gov and includes "PRO00104948" within the Unique Protocol ID: PRO00104948\_A - Acute Pain Trial - NCT05966129 PRO00104948\_B - Chronic Pain Trial - NCT05966142 PRO00104948\_C - Depression Trial - NCT05966155 Acute Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm) or standard care and pharmacogenetic testing after 6 months (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain management therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal. Chronic Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid 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 pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal. Depression: 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

Who Can Participate

Here is what you need to know about eligibility for this trial. Individuals aged 8 and older who speak English or Spanish. Those with acute pain after certain surgeries, chronic pain for at least 3 months, or diagnosed depression. Patients must not have a life expectancy of less than 12 months, be too ill to participate, or have certain prior genetic test results. Individuals with active psychosis, dementia, or certain other cognitive or neurological conditions may not be eligible. This trial is studying Depression, Acute Pain, Chronic Pain, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures track how many people are identified, screened, and enrolled in the different parts of the trial, ensuring the study can effectively test its hypotheses. The specific primary outcome measures are: Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record) (Up to 3 years); Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials (Up to 3 years); Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials (Up to 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it explores a personalized approach to pain and depression treatment, aiming to improve outcomes by tailoring medication choices based on an individual's genetic makeup. This research targets Depression, Acute Pain, Chronic Pain, where improved treatment options are needed.

Investor Insight

This trial signals a growing interest in pharmacogenetics for common conditions like pain and depression, potentially leading to more effective treatments and a larger market for genetic testing servi The large enrollment target of 4284 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if genetic testing is right for you and how it might affect your treatment plan. Participation involves genetic testing and potentially receiving medication guided by those results, with regular follow-ups. Day-to-day involvement will depend on the specific trial arm (acute pain, chronic pain, or depression) and may include taking medication and completing surveys. The trial is being conducted at 14 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

Acute Pain

* Age ≥ 8 years
* English speaking or Spanish speaking
* Elective/planned surgery types with planned or anticipated to be treated with tramadol, hydrocodone, or codeine pain management at an enrolling site, which may include orthopedic surgeries (e.g. arthroplasty, spine, etc.), open abdominal surgery, or cardiothoracic surgery and others

Chronic Pain

* Age ≥ 18 years
* English speaking or Spanish speaking
* Seen at primary care clinics (such as, but not limited to, Internal Medicine, Family Medicine or Pediatrics) or patients seen in pain-relevant specialty clinics
* History of pain for at least the last 3 months
* Currently treated or being considered for treatment with tramadol, hydrocodone, or codeine to improve pain management

Depression

* 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

Acute Pain

* Undergoing a laparoscopic surgery
* Receiving chronic opioid therapy, defined as use of opioids on most days for \>3 months

Chronic Pain

* Plan to move out of the area within 6 months of enrollment
* Undergoing treatment for an active cancer diagnosis
* Currently taking daily opioids other than tramadol, codeine or hydrocodone

Depression

* 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

Frequently Asked Questions

What is clinical trial NCT04445792?

NCT04445792 is a Not Applicable INTERVENTIONAL study titled "A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center)." It is currently completed and is sponsored by Duke University. The trial targets enrollment of 4284 participants.

What conditions does NCT04445792 study?

This trial investigates treatments for Depression, Acute Pain, Chronic Pain. The primary condition under study is Depression.

What treatments are being tested in NCT04445792?

The interventions being studied include: Pharmacogenetic testing (OTHER), Clinical decisions support (OTHER). Genetic testing of CYP2D6 and CYP2C19

What does Not Applicable mean for NCT04445792?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT04445792?

This trial is currently "Completed." It started on 2021-02-24. The estimated completion date is 2024-05-10.

Who is sponsoring NCT04445792?

NCT04445792 is sponsored by Duke University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04445792?

The trial aims to enroll 4284 participants. The trial status is completed.

How is NCT04445792 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT04445792?

The primary outcome measures are: Number of Individuals Identified as Potential Participants Through EHR (Electronic Health Record) (Up to 3 years); Number of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression Trials (Up to 3 years); Number of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression Trials (Up to 3 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04445792 being conducted?

This trial is being conducted at 14 sites, including Wilmington, Delaware; Gainesville, Florida; Jacksonville, Florida; Orlando, Florida and 10 more sites (United States).

Where can I find official information about NCT04445792?

The official record for NCT04445792 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04445792. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04445792 testing in simple terms?

This trial investigates if genetic testing can help doctors choose the best pain or depression medication for patients. It is for individuals experiencing acute pain after surgery, chronic pain, or depression.

Why is this trial significant?

This trial matters because it explores a personalized approach to pain and depression treatment, aiming to improve outcomes by tailoring medication choices based on an individual's genetic makeup.

What are the potential risks of participating in NCT04445792?

Risks include potential discomfort during blood draw for genetic testing. Side effects are primarily related to the medications prescribed for pain or depression, which would be discussed by your doctor. There's a possibility that the genetic information may not lead to a better treatment outcome. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04445792?

Ask your doctor if genetic testing is right for you and how it might affect your treatment plan. Participation involves genetic testing and potentially receiving medication guided by those results, with regular follow-ups. Day-to-day involvement will depend on the specific trial arm (acute pain, chronic pain, or depression) and may include taking medication and completing surveys. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04445792 signal from an investment perspective?

This trial signals a growing interest in pharmacogenetics for common conditions like pain and depression, potentially leading to more effective treatments and a larger market for genetic testing servi This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will be randomly assigned to receive genetic testing immediately to guide treatment or have testing delayed by 6 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.