CDDOM Oneome Rightmed Depression Study
Primary Purpose
Depression, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oneome RightMEd Pharmacogenomic testing Kit
Sponsored by
About this trial
This is an interventional treatment trial for Depression, Anxiety
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PGx-guided antidepressant therapy
Treat as usual based on Clinical Physician Recommendation
Arm Description
These individuals will be prescribed medication guided by the Oneome RightMed Test.
These individuals will receiving medication as usual based on the clinics internal guidelines and physician recommendations.
Outcomes
Primary Outcome Measures
determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04909749
First Posted
July 27, 2020
Last Updated
May 26, 2021
Sponsor
University of Arizona
Collaborators
OneOme, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04909749
Brief Title
CDDOM Oneome Rightmed Depression Study
Official Title
CDDOM Oneome Rightmed Depression Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
OneOme, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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:
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 excluded
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PGx-guided antidepressant therapy
Arm Type
Experimental
Arm Description
These individuals will be prescribed medication guided by the Oneome RightMed Test.
Arm Title
Treat as usual based on Clinical Physician Recommendation
Arm Type
No Intervention
Arm Description
These individuals will receiving medication as usual based on the clinics internal guidelines and physician recommendations.
Intervention Type
Genetic
Intervention Name(s)
Oneome RightMEd Pharmacogenomic testing Kit
Intervention Description
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
Primary Outcome Measure Information:
Title
determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lawrence Mandarino, PhD
Phone
5206266485
Email
mandarino@deptofmed.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar D Parra, MA
Phone
520-270-9113
Email
oscardp@email.arizona.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual results (IPD) will not be shared.
Learn more about this trial
CDDOM Oneome Rightmed Depression Study
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