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

Conditions

• Depression

Eligibility Criteria

Sex

ALL

Age

8 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pharmacogenetic testing — OTHER
  Genetic testing of CYP2D6 and CYP2C19
• Clinical decisions support — OTHER
  Prescribing recommendations to the provider based on the pharmacogenetic testing results

Study Details

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.

Key Dates

Start date

Aug 10, 2021

Status verified

Jun 2025

Primary completion

Apr 27, 2024

Completion

Apr 27, 2024

Study Design

Enrollment

1,572 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Depression - Immediate PGx Testing
  Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider
• Other: Depression - Delayed PGx Testing
  Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period

Primary Outcome Measure

Change in Depression Symptom Control as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System) [ Time Frame: Baseline to 3 months ]

Locations (14)

Find similar trials in Wilmington, DE

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