Depressive Disorder, Major, Medication Therapy Management, Pharmacogenetics
Conditions
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.
Interventions
OTHERPharmacogenomic Screening
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
Sponsors
Tuscaloosa Veterans Affairs Medical Center
Auburn University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 | — |
| Rate of pharmacogenomic variation with actionable recommendations for all actionable medications | At enrollment | — |
| 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 | — |
| Patient reported reasons for non-adherence | 3-, 6-, and 12-months post-recommendation via retrospective chart review | — |
Countries
United States
Outcome results
None listed