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

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.

Study Overview

• Status: Withdrawn
• Conditions: Depressive Disorder, Major; Pharmacogenetics; Medication Therapy Management
• Intervention / Treatment: Other: Pharmacogenomic Screening

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35404
      • Tuscaloosa VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pharmacogenomic Screening; Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits.

Other: Pharmacogenomic Screening; First telehealth appointment: Pharmacogenomics education and informed consent; Medical history; Sample collection Second telehealth appointment: Results of pharmacogenomic testing; Utility and limitations of pharmacogenomic testing; Patient-specific potential impacts on current or future medication therapies; Answering of patient questions; Referral to mental health provider(s) for treatment-specific recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of pharmacogenomic variation with actionable recommendations for medications currently utilized	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.	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of pharmacogenomic variation with actionable recommendations for all actionable medications		At enrollment
Mental health disease state control/progression utilizing disease state-specific validated tools	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.	3-, 6-, and 12-months post-recommendation via retrospective chart review
Medication-related costs	Claims data will be used to assess medication-related costs at specific time points.	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
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
Patient reported medication adherence and reasons for non-adherence		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
Number of pharmacogenomic recommendations made and accepted		3-, 6-, and 12-months post-recommendation via retrospective chart review
Type 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
Type of non-pharmacogenomic recommendations made and accepted		3-, 6-, and 12-months post-recommendation via retrospective chart review

Collaborators and Investigators

• Sponsor: Auburn University
• Collaborators: Tuscaloosa Veterans Affairs Medical Center
• Investigators: Study Director: Kimberly B Lloyd, Pharm.D., Auburn University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: TVA_IRBNetID_1614352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No