A Depression and Opioid Pragmatic Trial in Pharmacogenetics
Trial tests if genetic testing helps choose better antidepressants for depression.
Plain English Summary
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial) is a Not Applicable clinical trial sponsored by Duke University studying Depression. This trial tests if using genetic information can help doctors pick the right antidepressant medication for people with depression. It is for individuals aged 8 and older who have been diagnosed with depression and are starting or changing antidepressant medication. Participants will be randomly assigned to either receive genetic testing right away to guide their medication or receive standard care with genetic testing later. Alternatives include standard care where doctors choose antidepressants based on general guidelines and patient history, without genetic testing. The trial aims to enroll 1572 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 8 years or older, speak English or Spanish, have been diagnosed with depression, and are starting or changing SSRI antidepressants. You cannot join if you have a life expectancy of less than 12 months, are unable to consent, are institutionalized, have had a stem cell or liver transplant, or have had prior genetic testing for specific genes related to this study. Individuals with active psychosis, schizophrenia, dementia, cognitive developmental delay, seizure disorders, or bipolar disorder cannot participate in the depression trial. You also cannot join if you plan to move within 6 months of enrollment. This trial is studying Depression, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how much participants' depression symptoms improve over 3 months, indicating how well the genetic-guided treatment works compared to standard care. The specific primary outcome measures are: Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) (Baseline to 3 months). 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 aims to improve depression treatment by using genetic information to personalize medication choices, addressing a gap in current treatment approaches. This research targets Depression, where improved treatment options are needed.
Investor Insight
This trial signals a growing interest in pharmacogenetics for common conditions like depression, potentially leading to more personalized and effective treatments, which could represent a significant The large enrollment target of 1572 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 regular check-ins and symptom assessments, with some participants receiving genetic testing and others receiving standard care initially. The day-to-day involvement includes taking prescribed medication and attending study appointments for assessments. 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
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 1,572 participants
Interventions
- OTHER: Pharmacogenetic testing — Genetic testing of CYP2D6 and CYP2C19
- OTHER: Clinical decisions support — Prescribing recommendations to the provider based on the pharmacogenetic testing results
Primary Outcomes
- Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) (Baseline to 3 months)
Secondary Outcomes
- Change in Depression Symptomatology as Measured by Patient Health Questionnaire (PHQ-8) (Baseline to 3 months)
- Side Effect Burden (3 months)
- Medication Non-Adherence as Measured by the Voils Medication Adherence Survey (3 months)
- Number of Participants With Depression Remission as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) (6 months)
- Number of Participants With Depression Remission as Measured by the Patient Health Questionnaire (PHQ-8) (6 months)
Full 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
Trial Locations
- Nemours Children's Health System, Wilmington, Delaware, United States
- University of Florida - Gainesville, Gainesville, Florida, United States
- Nemours Children's Health System, Jacksonville, Florida, United States
- University of Florida - Jacksonville, Jacksonville, Florida, United States
- Nemours Children's Health System, Orlando, Florida, United States
- Eskenazi Health, Indianapolis, Indiana, United States
- Indiana University, Indianapolis, Indiana, United States
- Icahn School of Medicine at Mount Sinai, New York, New York, United States
- The Institute for Family Health, New York, New York, United States
- Duke University Medical Center, Durham, North Carolina, United States
- ...and 4 more locations
Frequently Asked Questions
What is clinical trial NCT05966155?
NCT05966155 is a Not Applicable INTERVENTIONAL study titled "A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)." It is currently completed and is sponsored by Duke University. The trial targets enrollment of 1572 participants.
What conditions does NCT05966155 study?
This trial investigates treatments for Depression. The primary condition under study is Depression.
What treatments are being tested in NCT05966155?
The interventions being studied include: Pharmacogenetic testing (OTHER), Clinical decisions support (OTHER). Genetic testing of CYP2D6 and CYP2C19
What does Not Applicable mean for NCT05966155?
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 NCT05966155?
This trial is currently "Completed." It started on 2021-08-10. The estimated completion date is 2024-04-27.
Who is sponsoring NCT05966155?
NCT05966155 is sponsored by Duke University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05966155?
The trial aims to enroll 1572 participants. The trial status is completed.
How is NCT05966155 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT05966155?
The primary outcome measures are: Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) (Baseline to 3 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05966155 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 NCT05966155?
The official record for NCT05966155 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05966155. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05966155 testing in simple terms?
This trial tests if using genetic information can help doctors pick the right antidepressant medication for people with depression. It is for individuals aged 8 and older who have been diagnosed with depression and are starting or changing antidepressant medication.
Why is this trial significant?
This trial matters because it aims to improve depression treatment by using genetic information to personalize medication choices, addressing a gap in current treatment approaches.
What are the potential risks of participating in NCT05966155?
Potential risks include side effects from antidepressant medications, which can vary by drug and individual. Some participants might experience a delay in finding the most effective treatment if they are in the standard care group. Genetic testing itself has minimal risk, but the interpretation and use of results could lead to anxiety or unexpected findings. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05966155?
Ask your doctor if genetic testing is right for you and how it might affect your treatment plan. Participation involves regular check-ins and symptom assessments, with some participants receiving genetic testing and others receiving standard care initially. The day-to-day involvement includes taking prescribed medication and attending study appointments for assessments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05966155 signal from an investment perspective?
This trial signals a growing interest in pharmacogenetics for common conditions like depression, potentially leading to more personalized and effective treatments, which could represent a significant 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 either receive genetic testing right away to guide their medication or receive standard care with genetic testing later. 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.
Related Conditions
More Depression Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.