Status:
UNKNOWN
CDDOM Oneome Rightmed Depression Study
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
OneOme, LLC
Conditions:
Depression, Anxiety
Eligibility:
All Genders
18-80 years
Phase:
NA
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 t...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04909749
Start Date
June 1 2021
End Date
June 1 2023
Last Update
June 2 2021
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