Individualizing Antidepressant Treatment Using Pharmacogenomics and EHR-driven Clinical Decision Support

Study Overview
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Brief Summary
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The purpose of this study is to understand the effectiveness of pharmacogenomic testing in using antidepressants and to understand how EHR - driven clinical decision support system can be used to deliver PGx test results by healhcare providers.

Official Title
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The myGenes Study:Individualizing Antidepressant Treatment Using Pharmacogenomics and EHR-driven Clinical Decision Support

Conditions
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Depression

Intervention / Treatment
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* Genetic: Genomind®Professional PGx Express TM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who quality the criteria below: Patients with nonpsychotic MDD Patients who would like to either start a new antidepressant or change their existing antidepressant treatment Patients for whom antidepressant treatment is deemed appropriate by the treating clinician >18 years of age Willingness to provide signed informed consent to participate in the study Will be following up or continuously visiting their physician Providers: Outpatient practice providers Providers who are familiar with Epic Exclusion Criteria: Patients: Patients with medical contraindications that preclude antidepressant treatment Patients with schizophrenia, schizoaffective disorder, or who have Bipolar I disorder Patients currently on antipsychotic medications (e.g., typical and atypical antipsychotic drugs) and mood stabilizing agents (e.g., lithium, carbamazepine, valproate, lamotrigine, gabapentin, or other anticonvulsants) Patients who are pregnant or have severe cognitive impairment Patients requiring urgent care or inpatient hospitalization at the time of consent Providers: • Unable or unwilling to commit time to introduce myGenes study to patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intervention group will have the PGx test results available via Epic, three days after the biospecimen is received. | Genetic: Genomind®Professional PGx Express TM<br>* The current test includes the analysis of fifteen pharmacodynamic genes and nine pharmacokinetic genes that have been shown in numerous clinical studies to have implications for response to treatments used for depression, anxiety, obsessive-compulsive disorder (OCD), attention-deficit/hyperactivity disorder (ADHD), bipolar disorder, Posttraumatic Stress Disorder (PTSD), autism, schizophrenia, chronic pain and substance abuse. The genes assessed by the assay target major hepatic enzymes and key neurotransmitter pathways including serotonin, dopamine, norepinephrine and glutamate.<br>|
| Experimental: Control group<br>The control group will be considered in TAU(treatment as usual) group but will have the PGx test results available after 24 weeks. Note: Patient in both the groups will be followed for 24 weeks and will take questionnaires every other week. | Genetic: Genomind®Professional PGx Express TM<br>* The current test includes the analysis of fifteen pharmacodynamic genes and nine pharmacokinetic genes that have been shown in numerous clinical studies to have implications for response to treatments used for depression, anxiety, obsessive-compulsive disorder (OCD), attention-deficit/hyperactivity disorder (ADHD), bipolar disorder, Posttraumatic Stress Disorder (PTSD), autism, schizophrenia, chronic pain and substance abuse. The genes assessed by the assay target major hepatic enzymes and key neurotransmitter pathways including serotonin, dopamine, norepinephrine and glutamate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response, as defined by > 50% reduction in Hamilton Depressing Rating Scale ( HAM-D) | The Hamilton Depression Rating Scale is used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression. The scoring system is as follows- 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-23 = Severe Depression > 23 = Very severe Depression. | 24 weeks | 
| Remission, as defined by < 8 on Hamilton Depressing Rating Scale ( HAM-D). | The Hamilton Depression Rating Scale is used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression. The scoring system is as follows- 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-23 = Severe Depression > 23 = Very severe Depression. | 24 weeks | 
| Conformance between antidepressant medication prescription changes and recommendations from the pharmacogenomics testing | Conformance is defined as the number of prescriptions that are in agreement with clinical decision support recommendations based on pharmacogenomics test results. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported side effects | FIBSER (Frequency, intensity and burden of side effects rating) questionnaire will be administered to assess the frequency, severity and degree of impairment related to side effects including nausea, headache, vomiting, GI distress, and sexual dysfunction. Frequency of side-effects are rated from 0-6, with 0 signifying no side effects and score of 6 showing that the effects are present all the time. Similarly intensity is also rated from 0-6 with 0 demonstrating no side effects and 6 signifying that the intensity is intolerable. Interference of side effects in day to day function is also rated in the same way. A reading of 0 tells us that there is no impairment of day-to-day functions and a reading of 6 depicts inability to function. | 24 weeks | 
| Provider Attitude | Number of overwritten CDS alerts regarding PGx testing will be used to determine if PGx-related CDS alerts will result in higher provider uptake compared to non-PGx-related CDS. | 24 weeks |