Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans

Not Applicable

Withdrawn

• Conditions: Depressive Disorder, Major; Medication Therapy Management; Pharmacogenetics
• Interventions: Other: Pharmacogenomic Screening

• Registration Number: NCT04893395
• Lead Sponsor: Auburn University

Brief Summary

The purpose of this study is to assess the prevalence of veterans with major depressive disorder (MDD) who are being treated with a medication that has current Clinical Pharmacogenetics Implementation Consortium (CPIC) or Pharmacogenomics Knowledgebase (PharmGKB) actionable recommendations that have a pharmacogenomic variation that impacts the safety or efficacy of the subject medication.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-14
• Study First Posted: 2021-05-19
• Study Start: 2021-09-01
• Primary Completion: 2022-04-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥ 19 years
2. Prescribed at least one chronic medication for mental health which is considered pharmacogenomically actionable, as defined above (amitriptyline, doxepin, imipramine, nortriptyline, citalopram, escitalopram, fluvoxamine, paroxetine, sertraline, or venlafaxine).
3. Diagnosis of major depressive disorder (MDD)

Exclusion Criteria

1. Subject is a prisoner or is under a court order for treatment as part of a sentence or incarceration
2. Persistent medication non-adherence for reasons not potentially linked to pharmacogenomic variation (e.g. inability to obtain medications due to cost; non-adherence due to cognitive impairment)
3. Individuals receiving mental health treatment/care from a non-VA facility
4. Individuals who are terminally ill
5. Inability to communicate in and/or understand English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacogenomic Screening	Pharmacogenomic Screening	Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits.

Primary Outcome Measures

Name	Time	Method
Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized	At enrollment	A medication history will be conducted at enrollment to ensure patient meets criteria for enrollment. Patients will provide a saliva sample at this timepoint. The rate of pharmacogenomic variation will be calculated based on current medications at enrollment; however, the pharmacogenomic screening panel may take up to 6 weeks to return to the patient and investigator.

Secondary Outcome Measures

Name	Time	Method
Type of pharmacogenomic recommendations made and accepted	3-, 6-, and 12-months post-recommendation via retrospective chart review
Medication-related adverse events	3-, 6-, and 12-months post-recommendation via retrospective chart review
Patient reported reasons for non-adherence	3-, 6-, and 12-months post-recommendation via retrospective chart review
Rate of pharmacogenomic variation with actionable recommendations for all actionable medications	At enrollment
Patient reported medication adherence and reasons for non-adherence	3-, 6-, and 12-months post-recommendation via retrospective chart review
Mental health disease state control/progression utilizing disease state-specific validated tools	3-, 6-, and 12-months post-recommendation via retrospective chart review	Validated, disease state-specific tools will be utilized to assess control or progression. Specifically, depression control will be assessed utilizing PHQ-9 as documented within the chart. This will be assessed via retrospective chart review.
Number of primary care, mental health provider, mental health pharmacist, specialist, and emergency room visits and hospitalizations	3-, 6-, and 12-months post-recommendation via retrospective chart review
Type of non-pharmacogenomic recommendations made and accepted	3-, 6-, and 12-months post-recommendation via retrospective chart review
Medication-related costs	3-, 6-, and 12-months post-recommendation via retrospective chart review	Claims data will be used to assess medication-related costs at specific time points.
Number of pharmacogenomic recommendations made and accepted	3-, 6-, and 12-months post-recommendation via retrospective chart review
Number of non-pharmacogenomic recommendations made and accepted	3-, 6-, and 12-months post-recommendation via retrospective chart review

Trial Locations

Locations (1)

Tuscaloosa VAMC; 🇺🇸 Tuscaloosa, Alabama, United States