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

Weill Cornell Medicine (WCM)

Status: Withdrawn

Conditions: Depression

Treatments: Genetic: Genomind®Professional PGx Express TM

Study type: Interventional

Funder types: Other

Identifiers

NCT03952494

1806019379

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Intervention group

Experimental group

Description:

Intervention group will have the PGx test results available via Epic, three days after the biospecimen is received.

Treatment:

Genetic: Genomind®Professional PGx Express TM

Control group

Experimental group

Description:

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.

Treatment:

Genetic: Genomind®Professional PGx Express TM