CDDOM Oneome Rightmed Depression Study

NCT04909749 | Unknown

• 1 other identifier: 1901270218
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (2)

PGx-guided antidepressant therapy

EXPERIMENTAL

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

Genetic: Oneome RightMEd Pharmacogenomic testing Kit

Treat as usual based on Clinical Physician Recommendation

NO INTERVENTION

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

Interventions

Oneome RightMEd Pharmacogenomic testing Kit GENETIC

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

PGx-guided antidepressant therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• OneOme, LLC: collaborator

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Lawrence Mandarino, PhD

CONTACT

5206266485; mandarino@deptofmed.arizona.edu

Oscar D Parra, MA

CONTACT

520-270-9113; oscardp@email.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Primary study Investigator(s) and analyzers of samples with be masked. Only one co-I responsible for group randomization will be unmasked to study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division Chief, CDDOM Director

Model Details: 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

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: June 2, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share