CDDOM Oneome Rightmed Depression Study
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lawrence Mandarino, PhD
- Número de teléfono: 5206266485
- Correo electrónico: mandarino@deptofmed.arizona.edu
Copia de seguridad de contactos de estudio
- Nombre: Oscar D Parra, MA
- Número de teléfono: 520-270-9113
- Correo electrónico: oscardp@email.arizona.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PGx-guided antidepressant therapy
These individuals will be prescribed medication guided by the Oneome RightMed Test.
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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
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Sin intervención: Treat as usual based on Clinical Physician Recommendation
These individuals will receiving medication as usual based on the clinics internal guidelines and physician recommendations.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication
Periodo de tiempo: 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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1901270218
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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