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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04893395
• Other study ID #: TVA_IRBNetID_1614352
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Medication Therapy Management
• Pharmacogenetics

Intervention

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

Locations

Country	Name	City	State
United States	Tuscaloosa VAMC	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Auburn University	Tuscaloosa Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of pharmacogenomic variation with actionable recommendations for all actionable medications		At enrollment
Secondary	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
Secondary	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
Secondary	Medication-related adverse events		3-, 6-, and 12-months post-recommendation via retrospective chart review
Secondary	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
Secondary	Patient reported medication adherence and reasons for non-adherence		3-, 6-, and 12-months post-recommendation via retrospective chart review
Secondary	Patient reported reasons for non-adherence		3-, 6-, and 12-months post-recommendation via retrospective chart review
Secondary	Number of pharmacogenomic recommendations made and accepted		3-, 6-, and 12-months post-recommendation via retrospective chart review
Secondary	Type of pharmacogenomic recommendations made and accepted		3-, 6-, and 12-months post-recommendation via retrospective chart review
Secondary	Number of non-pharmacogenomic recommendations made and accepted		3-, 6-, and 12-months post-recommendation via retrospective chart review
Secondary	Type of non-pharmacogenomic recommendations made and accepted		3-, 6-, and 12-months post-recommendation via retrospective chart review