RecruitingPhase 4NCT07266545

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


Sponsor

Mayo Clinic

Enrollment

120 participants

Start Date

Feb 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether changes in RNA editing (a biological process in cells) in the blood can predict how well people with depression will respond to antidepressant treatment. It aims to enroll people with major depressive disorder (MDD) or bipolar depression who are starting a new antidepressant. This is a biomarker and treatment response study. **You may be eligible if...** - You are between 18 and 65 years old - You have a current episode of major depression, confirmed by clinical interview (for MDD or bipolar disorder I or II) - Your depression symptoms are at least moderate in severity - You can speak and understand English - You are able to travel to assessment visits - If you have bipolar I disorder, you must be on a mood stabilizer **You may NOT be eligible if...** - You have treatment-resistant depression (failed 2 or more adequate antidepressant trials in the current episode) - You are actively suicidal or have made a medically serious suicide attempt in the past 6 months - You have active psychosis, schizophrenia, or significant mixed mood symptoms - You currently use or have recently used certain medications that could interfere with the study drugs - You have a current substance use disorder (other than nicotine) - You are pregnant, breastfeeding, or not using contraception - You have significant medical conditions such as severe kidney or liver disease, epilepsy, or eating disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT07266545


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