Vortioxetine and Cariprazine for Unipolar and Bipolar Depression

This study, called EDIT-ANDRE, is looking at how a treatment for depression works in people with unipolar or bipolar depression. Researchers want to understand if changes in RNA editing (a natural process that modifies genetic instructions) can predict how well someone responds to treatment. You would first take vortioxetine once daily for 8 weeks. If your depression doesn't improve enough, you might then add cariprazine to your treatment for another 8 weeks. The main goal is to see how much your depression symptoms improve, measured by a scale called the Montgomery-Åsberg Depression Rating Scale (MADRS). The study is recruiting 120 adults between 18 and 65 years old who have current major depressive episodes.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 120 participants with unipolar or bipolar depression.
What's involved
You would take vortioxetine for 8 weeks. If needed, you would then add cariprazine for another 8 weeks. Your depression symptoms will be measured at several points over 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be monitored for 16 weeks, with the last measurement at Week 16.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07266545

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

Recruiting
PHASE4Ages 18–65InterventionalTreatment
Mayo Clinic
~120 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:VortioxetineCariprazine (Augmentation Phase)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
Measured over Baseline, Week 2, Week 8, Week 10, Week 16
Unipolar Depression
Bipolar Depression
1 sites across 1 states
Minnesota1
  • Aysegul Ozerdem, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Deniz Ceylan, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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  • Change in Montgomery-Åsberg Depression Rating Scale (MADRS) scoreBaseline, Week 2, Week 8, Week 10, Week 16

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is scored on a scale of 0 to 60, with each of the 10 items rated from 0 to 6 by a trained clinician during an interview. A higher score indicates a more severe level of depression, with common severity ranges being: 0-6 (normal), 7-19 (mild), 20-34 (moderate), and 35-60 (severe).