MedTrace Logo

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

NCT07266545 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Aysegul Ozerdem, MD, PhD · Mayo Clinic

  • Deniz Ceylan, MD, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-17
Primary Completion
2028-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266545 on ClinicalTrials.gov