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

NCT05966155 | Completed Results DMC

• 2 other identifiers: PRO00104948_CU01HG010225
• Study Type: interventional
• Target: 1,572
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Depression

Keywords

Pharmacogenetic; CYP2D6; CYP2C19

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 3 months

Secondary Outcomes (7)

• 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

Study Arms (2)

Depression - Immediate PGx Testing

EXPERIMENTAL

Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider

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

Other: Pharmacogenetic testing

Interventions

Pharmacogenetic testing OTHER

Genetic testing of CYP2D6 and CYP2C19

Depression - Delayed PGx Testing; Depression - Immediate PGx Testing

Clinical decisions support OTHER

Prescribing recommendations to the provider based on the pharmacogenetic testing results

Depression - Immediate PGx Testing

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Has a seizure disorder
• Have bipolar disorder

Sponsors & Collaborators

• Duke University: lead
• National Human Genome Research Institute (NHGRI): collaborator
• University of Florida: collaborator
• Vanderbilt University Medical Center: collaborator
• Indiana University School of Medicine: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (14)

Nemours Children's Health System

Wilmington, Delaware, 19803, United States

Location

University of Florida - Gainesville

Gainesville, Florida, 32610, United States

Location

Nemours Children's Health System

Jacksonville, Florida, 32207, United States

Location

University of Florida - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Nemours Children's Health System

Orlando, Florida, 32827, United States

Location

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Institute for Family Health

New York, New York, 10035, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Sanford Health

Fargo, North Dakota, 58104, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Nashville General Hospital

Nashville, Tennessee, 37208, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 38860639 BACKGROUND

Related Links

• Rationale and design for a pragmatic randomized trial to assess gene-based prescribing for SSRIs in the treatment of depression

MeSH Terms

Conditions

Depression

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Results Point of Contact

• Title: Hrishikesh Chakraborty, PhD
• Organization: Duke University

hrishikesh.chakraborty@duke.edu

919-668-1238

Study Officials

• Hrishikesh Chakraborty

  Duke University

  STUDY DIRECTOR

• Josh F. Peterson, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: August 10, 2021
• Primary Completion: April 27, 2024
• Study Completion: April 27, 2024
• Last Updated: June 29, 2025
• Results First Posted: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)