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CDDOM Oneome Rightmed Depression Study

26. maj 2021 opdateret af: Lawrence Mandarino, University of Arizona

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

350

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PGx-guided antidepressant therapy
These individuals will be prescribed medication guided by the Oneome RightMed Test.
Genetisk: 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
Ingen indgriben: Treat as usual based on Clinical Physician Recommendation
These individuals will receiving medication as usual based on the clinics internal guidelines and physician recommendations.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication
Tidsramme: 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.
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Arizona

Samarbejdspartnere

OneOme, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. juni 2021

Primær færdiggørelse (Forventet)

1. juni 2022

Studieafslutning (Forventet)

1. juni 2023

Datoer for studieregistrering

Først indsendt

27. juli 2020

Først indsendt, der opfyldte QC-kriterier

26. maj 2021

Først opslået (Faktiske)

2. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1901270218

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

IPD-planbeskrivelse

Individual results (IPD) will not be shared.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Depression, angst

Kliniske forsøg med Oneome RightMEd Pharmacogenomic testing Kit

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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