RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)
Mayo Clinic
Summary
The purpose of this research is to understand how changes in RNA editing relate to treatment response in unipolar and bipolar depression.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult females and males, aged 18-65 years * Must have the capacity to understand study procedures, to comply with them for the entire length of the study, and to provide informed consent. * Current major depressive episodes associated with MDD, BD-I, or BD-II, confirmed using the SCID-IV-CV. * Symptom severity score on the Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C16) \> 10. * Ability to travel for assessment visits. * Negative urine pregnancy test for people of childbearing potential * People of childbearing potential must be using an acceptable m…
Interventions
- DrugVortioxetine
Vortioxetine, once daily, for 8 weeks
- DrugBupropion extended release
Bupropion extended release, once daily, for 8 weeks
- DrugCariprazine (Augmentation Phase)
Participants who do not meet remission criteria will enter a second 8-week augmentation phase (Weeks 9-16). During this phase, cariprazine will be added to the existing regimen, administered orally once daily in the morning, starting at 1.5 mg/day and titrated up to 3.0 mg/day in one week.
Location
- Mayo Clinic in RochesterRochester, Minnesota