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

Not Applicable

Withdrawn

• Conditions: Depression
• Interventions: Genetic: Genomind®Professional PGx Express TM

• Registration Number: NCT03952494
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-08
• Study Start: 2022-03-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Genomind®Professional PGx Express TM	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.
Intervention group	Genomind®Professional PGx Express TM	Intervention group will have the PGx test results available via Epic, three days after the biospecimen is received.

Primary Outcome Measures

Name	Time	Method
Response, as defined by > 50% reduction in Hamilton Depressing Rating Scale ( HAM-D)	24 weeks	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.
Remission, as defined by < 8 on Hamilton Depressing Rating Scale ( HAM-D).	24 weeks	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.
Conformance between antidepressant medication prescription changes and recommendations from the pharmacogenomics testing	24 weeks	Conformance is defined as the number of prescriptions that are in agreement with clinical decision support recommendations based on pharmacogenomics test results.

Secondary Outcome Measures

Name	Time	Method
Self-reported side effects	24 weeks	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.
Provider Attitude	24 weeks	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.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States