Trials / Recruiting
RecruitingNCT07266545
RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research is to understand how changes in RNA editing relate to treatment response in unipolar and bipolar depression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vortioxetine | Vortioxetine, once daily, for 8 weeks |
| DRUG | Bupropion extended release | Bupropion extended release, once daily, for 8 weeks |
| DRUG | Cariprazine (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. |
Timeline
- Start date
- 2026-02-17
- Primary completion
- 2028-12-31
- Completion
- 2030-12-31
- First posted
- 2025-12-05
- Last updated
- 2026-02-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07266545. Inclusion in this directory is not an endorsement.