Clinical trial NCT03952494: Individualizing Antidepressant Treatment Using Pharmacogenomics and EHR-driven Clinical Decision Support
Official title: The myGenes Study:Individualizing Antidepressant Treatment Using Pharmacogenomics and EHR-driven Clinical Decision Support
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Leon Lowenstein Foundation Inc.
First posted: 2019-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Response, as defined by > 50% reduction in Hamilton Depressing Rating Scale ( HAM-D)
timeFrame: 24 weeks
measure: Remission, as defined by < 8 on Hamilton Depressing Rating Scale ( HAM-D).
timeFrame: 24 weeks
measure: Conformance between antidepressant medication prescription changes and recommendations from the pharmacogenomics testing
timeFrame: 24 weeks
Secondary outcomes:
measure: Self-reported side effects
timeFrame: 24 weeks
measure: Provider Attitude
timeFrame: 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jyotishman Pathak, PhD
role: PRINCIPAL_INVESTIGATOR
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