RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

Conditions

Vortioxetine — DRUG
Vortioxetine, once daily, for 8 weeks
Bupropion extended release — DRUG
Bupropion extended release, once daily, for 8 weeks
Cariprazine (Augmentation Phase) — DRUG
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.

The purpose of this research is to understand how changes in RNA editing relate to treatment response in unipolar and bipolar depression.

Experimental: Vortioxetine
Subjects randomized to the vortioxetine arm will begin 8 weeks of treatment with vortioxetine at 10 mg/day, titrated to 20 mg/day (after 7 days). Subjects who do not meet remission criteria will enter a second 8 week augmentation phase.
Experimental: Bupropion
Subjects randomized to the bupropion arm will begin 8 weeks of treatment with buproprion extended release at 150 mg/day; titrated to 300 mg/day (after 7 days) Subjects who do not meet remission criteria will enter a second 8 week augmentation phase.

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score [ Time Frame: Baseline, Week 2, Week 8, Week 10, Week 16 ]

Facility	City	State	ZIP	Site coordinators
Mayo Clinic in Rochester	Rochester	Minnesota	55905	Scott E. Feeder 507-255-1975 Aysegul Ozerdem, MD, PhD (PRINCIPAL_INVESTIGATOR) Deniz Ceylan, MD, PhD (PRINCIPAL_INVESTIGATOR)

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