CDDOM Oneome Rightmed Depression Study

Not Applicable

• Conditions: Depression, Anxiety
• Interventions: Genetic: Oneome RightMEd Pharmacogenomic testing Kit

• Registration Number: NCT04909749
• Lead Sponsor: University of Arizona

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.

Detailed Description

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.

Primary Outcomes:

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.

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.

2. 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:

1. Medication changes - Number of antidepressant medication changes and/or dose adjustments per subject from baseline to study endpoint.

2. 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 Timeline

• Study First Submitted: 2020-07-27
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-26
• Last Update Submitted: 2021-05-26
• Study Start: 2021-06
• Study First Posted: 2021-06-02
• Last Update Posted: 2021-06-02
• Primary Completion: 2022-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGx-guided antidepressant therapy	Oneome RightMEd Pharmacogenomic testing Kit	These individuals will be prescribed medication guided by the Oneome RightMed Test.

Primary Outcome Measures

Name	Time	Method
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.