NCT03170362: PRIME Care

PRIME Care (PRecision Medicine In MEntal Health Care)

Completed NA Results posted Last updated 28 May 2024

What this trial tests

NA trial testing Pharmacogenetic Test in Major Depression in 1,944 participants. Completed in 31 March 2022.

Timeline

15 June 2017

Primary endpoint
30 October 2021

31 March 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1,944
Start date	15 June 2017
Primary completion	30 October 2021
Estimated completion	31 March 2022
Sites	24 locations across United States

Drugs / interventions tested

• Pharmacogenetic Test

Conditions studied

• Major Depression — all drugs for Major Depression →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 80, any sex, with Major Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Depression Remission Primary · 24 weeks post randomization

The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Remission was defined as a score of 5 or less at the endpoint. the reported number of participants are those reaching that threshold of symptoms.

Group	Value	95% CI
Intervention Group	130
Delay Results Group	126

Use of Fewer Medications That Have Potential Gene-drug Interactions Primary · Over the first 30 days

The investigators will examine the proportion of antidepressants prescribed in the first 30 days of the trial that have the potential for gene-drug interactions. The chance for a gene-drug interaction was classified as 1. the subject did not have a prescription for an antidepressant during the initial 4 weeks of the trial (No Antidepressant), 2 the subject was prescribed an antidepressant with no known gene-drug interaction (No Gene Interaction), 3 the subject was prescribed an antidepressant with moderate gene-drug interactions (Moderate Interaction). These are also gene-drug interactions tha

Group	Value	95% CI
Intervention Group	239
Delay Results Group	299
Intervention Group	433
Delay Results Group	173
Intervention Group	215
Delay Results Group	373
Intervention Group	79
Delay Results Group	133

Depression Severity Secondary · 24 Weeks

The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self-assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. This measure will use the PHQ9 as a continuous measure. The reported outcome is the difference in scores from baseline to 24 weeks.

Group	Value	95% CI
Intervention Group	5.4	± 5.9
Delay Results Group	4.8	± 5.6

Depression Response Secondary · 24 weeks

The investigators will use the Patient Health Questionnaire 9 (PHQ9) as a self assessed marker of depression remission. The scale ranges from 0 to 27 with lower scores indicating less depression severity. Response was measured by a 50% reduction in scores from baseline to each time point.

Group	Value	95% CI
Intervention Group	242
Delay Results Group	216

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Group

Serious: 76/966 (8%)

Deaths: 2/966

Delay Results Group

Serious: 70/978 (7%)

Deaths: 2/978

Serious adverse events (13 terms)

Reaction	System	Intervention Group	Delay Results Group
Hospitalization	Psychiatric disorders	—	—
Hospitalization	Musculoskeletal and connective tissue disorders	—	—
Hospitalization	Gastrointestinal disorders	—	—
Hospitalization	Cardiac disorders	—	—
Hospitalization	Infections and infestations	—	—
Hospitalization	Nervous system disorders	—	—
Hospitalization	Respiratory, thoracic and mediastinal disorders	—	—
Hospitalization	Endocrine disorders	—	—
Hospitalization	Ear and labyrinth disorders	—	—
Hospitalization	Renal and urinary disorders	—	—
Hospitalization	Blood and lymphatic system disorders	—	—
Incarceration	Social circumstances	—	—
Hospitalization	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Intervention Group	Delay Results Group
Sexual side effects	Reproductive system and breast disorders	—	—
Headache	Nervous system disorders	—	—
GI distress	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Fatigue	Nervous system disorders	—	—
Insomnia	Nervous system disorders	—	—

Most-reported serious reactions: Hospitalization, Hospitalization, Hospitalization, Hospitalization, Hospitalization, Hospitalization, Hospitalization, Hospitalization.

Data from ClinicalTrials.gov NCT03170362 adverse events section.

Sponsor's own description

The focus of this application is on the impact of providing depressed Veterans and their providers with the results of pharmacogenetic (PGx) testing for psychotropic medications. The project focuses on whether and how patients and providers use genetic test results given to them at the time an antidepressant is to be initiated to treat Major Depressive Disorder (MDD) and whether use of the test results improves patient outcomes. MDD is one of the most common conditions associated with military service and combat exposure, increases suicide risk, and worsens the course of common medical conditions, making it a leading cause of functional impairment and mortality. Validation of a PGx test to personalize the treatment of MDD represents an important opportunity to improve the healthcare of Veterans.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Pharmacogenomic Testing for Drug-Gene Interactions on Medication Selection and Remission of Symptoms in Major Depressive Disorder: The PRIME Care Randomized Clinical Trial.
   Oslin DW, Lynch KG, Shih MC, Ingram EP, et al · · 2022 · cited 127× · PMID 35819423 · DOI 10.1001/jama.2022.9805
2. Pharmacogenomic Testing and Depressive Symptom Remission: A Systematic Review and Meta-Analysis of Prospective, Controlled Clinical Trials.
   Brown LC, Stanton JD, Bharthi K, Maruf AA, et al · · 2022 · cited 90× · PMID 36111494 · DOI 10.1002/cpt.2748
3. Primary care and mental health providers' perceptions of implementation of pharmacogenetics testing for depression prescribing.
   Vest BM, Wray LO, Brady LA, Thase ME, et al · · 2020 · cited 39× · PMID 33115428 · DOI 10.1186/s12888-020-02919-z
4. VA Primary Care and Mental Health Providers' Comfort with Genetic Testing: Survey Results from the PRIME Care Study.
   Hull LE, Lynch KG, Oslin DW. · · 2019 · cited 18× · PMID 30604117 · DOI 10.1007/s11606-018-4776-0
5. Efficacy and safety of pharmacogenomic-guided antidepressant prescribing in patients with depression: an umbrella review and updated meta-analysis.
   Tesfamicael KG, Zhao L, Fernández-Rodríguez R, Adelson DL, et al · · 2024 · cited 12× · PMID 39086729 · DOI 10.3389/fpsyt.2024.1276410
6. Study design and implementation of the PRecision Medicine In MEntal health Care (PRIME Care) Trial.
   Oslin DW, Chapman S, Duvall SL, Gelernter J, et al · · 2021 · cited 12× · PMID 33316457 · DOI 10.1016/j.cct.2020.106247
7. Pharmacogenetic testing in the Veterans Health Administration (VHA): policy recommendations from the VHA Clinical Pharmacogenetics Subcommittee.
   Vassy JL, Stone A, Callaghan JT, Mendes M, et al · · 2019 · cited 11× · PMID 29858578 · DOI 10.1038/s41436-018-0057-x
8. Early adoption of pharmacogenetic testing for veterans prescribed psychotropic medications.
   Hull LE, Chanfreau-Coffinier C, Tuteja S, Berlowitz D, et al · · 2019 · cited 4× · PMID 31393222 · DOI 10.2217/pgs-2019-0065