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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Lawrence Mandarino, PhD
- Numero di telefono: 5206266485
- Email: mandarino@deptofmed.arizona.edu
Backup dei contatti dello studio
- Nome: Oscar D Parra, MA
- Numero di telefono: 520-270-9113
- Email: oscardp@email.arizona.edu
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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determine the effectiveness and feasibility of implementing a pharmacogenomic (PGx) approach to prescribing antidepressant medication
Lasso di tempo: 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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Completamento dello studio (Anticipato)
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
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Altri numeri di identificazione dello studio
- 1901270218
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