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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07266545
Phase
PHASE4
Status
Recruiting
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Conditions

  • Bipolar Depression
  • Unipolar Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Vortioxetine — DRUG
    Vortioxetine, once daily, for 8 weeks
  • Cariprazine (Augmentation Phase) — DRUG
    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.

Study Details

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

Key Dates

First listed
Dec 5, 2025
Start date
Feb 17, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vortioxetine
    Subjects will be started on vortioxetine for 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.

Primary Outcome Measure

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score [ Time Frame: Baseline, Week 2, Week 8, Week 10, Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Scott E. Feeder
507-255-1975
Aysegul Ozerdem, MD, PhD (PRINCIPAL_INVESTIGATOR)
Deniz Ceylan, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN

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