CDDOM Oneome Rightmed Depression Study

Sponsor

University of Arizona (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04909749

Collaborator

OneOme, LLC (Industry)

350

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In this study, we hypothesize PGx guided testing can improve outcomes related to treatment of moderate and severe depression among El Rio Community Health patients. We anticipate patients randomized to the OneOme RightMed® PGx test will demonstrate a greater improvement of depressive symptoms and will have a higher proportion of subjects reporting response and remission than those receiving standard care.

Our purpose is to determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication in an underserved, community health center patient population.

Condition or Disease	Intervention/Treatment	Phase
Depression, Anxiety	Genetic: Oneome RightMEd Pharmacogenomic testing Kit	N/A

Detailed Description

Primary Outcomes:

Changes in patient depressive ratings will be the primary endpoint in this study. The primary outcome will be measured using the validated Patient Health Questionnaire (PHQ-9) depression rating scale, administered verbally to participants.

Depression response and remission rates (proportion of subjects achieving or not achieving), in the control and intervention arm will be directly compared at baseline, 2, 4, 8, and 12 weeks.

Patient progression from primary care to El Rio behavioral health (BH) specialty care will also be monitored in this study. We will directly compare the proportion of subjects in the control and intervention arm requiring BH consultation at any point in the study.

Secondary Outcomes:

Medication changes - Number of antidepressant medication changes and/or dose adjustments per subject from baseline to study endpoint.
Medication congruence - Alignment of physicians to RightMed test recommendations in control and intervention arm (guided vs unguided) and time to achieve optimal medication selection (green bin).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Approximately 100,000 patients are clinically managed by El Rio providers each year. A PHQ-2 is routinely completed by all visiting patients at El Rio health to screen for depression. Patients who screen positive on the PHQ-2 subsequently take the PHQ-9, a similar but more sensitive and specific depression assessment tool. For our study, a total of 350 patients will be recruited and randomized to PGx-guided antidepressant therapy (n= 175) or treatment as usual (n =175). Patients who are currently clinically managed for depression will be eligible for participation as well. Patients who are pregnant, have a history of major depressive disorder, or a concurrent diagnosis of other psychiatric issues will be excluded. Patients who will not be treated with antidepressants will be excludedApproximately 100,000 patients are clinically managed by El Rio providers each year. A PHQ-2 is routinely completed by all visiting patients at El Rio health to screen for depression. Patients who screen positive on the PHQ-2 subsequently take the PHQ-9, a similar but more sensitive and specific depression assessment tool. For our study, a total of 350 patients will be recruited and randomized to PGx-guided antidepressant therapy (n= 175) or treatment as usual (n =175). Patients who are currently clinically managed for depression will be eligible for participation as well. Patients who are pregnant, have a history of major depressive disorder, or a concurrent diagnosis of other psychiatric issues will be excluded. Patients who will not be treated with antidepressants will be excluded

Masking:

Double (Participant, Investigator)

Masking Description:

Primary study Investigator(s) and analyzers of samples with be masked. Only one co-I responsible for group randomization will be unmasked to study.

Primary Purpose:

Treatment

Official Title:

CDDOM Oneome Rightmed Depression Study

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PGx-guided antidepressant therapy These individuals will be prescribed medication guided by the Oneome RightMed Test.	Genetic: Oneome RightMEd Pharmacogenomic testing Kit The RightMed test is an end-to-end solution which includes sample collection, pharmacogenomic (PGx) testing services, data analysis, and clinical interpretation that helps physicians select treatments based on evidence-driven predictions of patient drug response and tolerance. Genetic components of an individual's drug response are well established and often included on Food and Drug Administration (FDA) medication labels. The OneOme RightMed test has incorporated existing evidence to classify the risk and likelihood of an antidepressant working for different patients. Patient results for each medication can fall into one of three categories: 1.) Green - use as directed; 2.) Yellow - use with caution; and 3.) Red - adjust dose or choose alternative mediation and can be used proactively or reactively
No Intervention: Treat as usual based on Clinical Physician Recommendation These individuals will receiving medication as usual based on the clinics internal guidelines and physician recommendations.

Arm

Intervention/Treatment

Experimental: PGx-guided antidepressant therapy

These individuals will be prescribed medication guided by the Oneome RightMed Test.

Genetic: Oneome RightMEd Pharmacogenomic testing Kit

The RightMed test is an end-to-end solution which includes sample collection, pharmacogenomic (PGx) testing services, data analysis, and clinical interpretation that helps physicians select treatments based on evidence-driven predictions of patient drug response and tolerance. Genetic components of an individual's drug response are well established and often included on Food and Drug Administration (FDA) medication labels. The OneOme RightMed test has incorporated existing evidence to classify the risk and likelihood of an antidepressant working for different patients. Patient results for each medication can fall into one of three categories: 1.) Green - use as directed; 2.) Yellow - use with caution; and 3.) Red - adjust dose or choose alternative mediation and can be used proactively or reactively

No Intervention: Treat as usual based on Clinical Physician Recommendation

These individuals will receiving medication as usual based on the clinics internal guidelines and physician recommendations.

Outcome Measures

Primary Outcome Measures

determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication [2 years]
Our purpose is to determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication in an underserved, community health center patient population 1.) Changes in patient depressive ratings will be the primary endpoint in this study. The primary outcome will be measured using the validated Patient Health Questionnaire (PHQ-9) depression rating scale, administered verbally to participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18-80 years of age
PHQ-9 score ≥ 10
Suffer from Major Depressive Disorder meeting DSM-V criteria and meet at least one of the following:
Either new to antidepressant treatment or currently taking medication for less than 6 weeks.
Inadequate efficacy after at least 6 weeks of antidepressant treatment
Have discontinued antidepressant treatment due to adverse events or intolerability within the last 6 weeks
Must be able to understand requirements of the study and provide written informed consent (English or Spanish)

Exclusion Criteria:

Any patient for whom providing a buccal swab sample would be contraindicated or not possible.
Patients taking antidepressants for > 6 months consecutively prior to baseline unless determined to be inadequate efficacy and PCP looking to change medication.
Subjects diagnosed as not having or depression.
Patients with history of prior PGx testing
Inability to provide informed consent
Current diagnosis of bipolar disorder type I or II, psychosis, schizophrenia and/or schizoaffective disorder
Inability to attend scheduled study visits
Patients who are known to be pregnant or lactating
Patients that are diagnosed with severe depression

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Arizona
OneOme, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lawrence Mandarino, Professor, Division Chief, CDDOM Director, University of Arizona

ClinicalTrials.gov Identifier:

NCT04909749

Other Study ID Numbers:

1901270218

First Posted:

Jun 2, 2021

Last Update Posted:

Jun 2, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Jun 2, 2021