Vortioxetine + Bupropion + Cariprazine for Depression

Overseen By Scott E. Feeder

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Aysegul Ozerdem, MD, PhD

Principal Investigator

Mayo Clinic

Deniz Ceylan, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

Negative urine pregnancy test for people of childbearing potential

I am between 18 and 65 years old.

I understand the study's procedures and can follow them.

Exclusion Criteria

No access to smartphones, internet

Meeting symptomatic remission criteria based on MADRS (≤ 10)

Individuals who cannot understand English will not be enrolled because informed consent, study procedures, and interviews require comprehension of English

What Are the Treatments Tested in This Trial?

Interventions

• RNA Editing

How Is the Trial Designed?

Group I: Vortioxetine Experimental Treatment 2 Interventions

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.

Group II: Bupropion Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+