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

NCT04893395 | Withdrawn

• 1 other identifier: TVA_IRBNetID_1614352
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacogenetics; Depressive Disorder, Major; Medication Therapy Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

  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

• 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

Study Arms (1)

Pharmacogenomic Screening

EXPERIMENTAL

Eligible patients who verbally consent to participate will receive two pharmacogenomics telehealth visits.

Other: Pharmacogenomic Screening

Interventions

Pharmacogenomic Screening OTHER

First telehealth appointment: 1. Pharmacogenomics education and informed consent 2. Medical history 3. Sample collection Second telehealth appointment: 1. Results of pharmacogenomic testing 2. Utility and limitations of pharmacogenomic testing 3. Patient-specific potential impacts on current or future medication therapies 4. Answering of patient questions 5. Referral to mental health provider(s) for treatment-specific recommendations

Pharmacogenomic Screening

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years
• 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).
• Diagnosis of major depressive disorder (MDD)

You may not qualify if:

• Subject is a prisoner or is under a court order for treatment as part of a sentence or incarceration
• 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)
• Individuals receiving mental health treatment/care from a non-VA facility
• Individuals who are terminally ill
• Inability to communicate in and/or understand English

Sponsors & Collaborators

• Auburn University: lead
• Tuscaloosa Veterans Affairs Medical Center: collaborator

Study Sites (1)

Tuscaloosa VAMC

Tuscaloosa, Alabama, 35404, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

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

Study Officials

• Kimberly B Lloyd, Pharm.D.

  Auburn University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 19, 2021
• Study Start: September 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)