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

NCT07266545 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-006875
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Unipolar Depression; Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score

  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).

  Baseline, Week 2, Week 8, Week 10, Week 16

Study Arms (1)

Vortioxetine

EXPERIMENTAL

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.

Drug: Vortioxetine; Drug: Cariprazine (Augmentation Phase)

Interventions

Vortioxetine DRUG

Vortioxetine, once daily, for 8 weeks

Vortioxetine

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.

Vortioxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all the following criteria to be eligible for the study:
• Adult females and males, aged 18-65 years
• Must have the capacity to understand study procedures, to comply with them for the entire length of the study, and to provide informed consent.
• Current major depressive episodes associated with MDD, BD-I, or BD-II, confirmed using the SCID-IV-CV. If a participant has already completed a structured diagnostic interview within the last 2 years or participated in any of the following studies and provided consent to use their information in future studies: (IRB 19-001722, IRB: 23-004500, IRB: 24-013228, IRB: 25-005856, IRB: 25-007244), those SCID results can be used for the EDIT-ANDRE study.
• Symptom severity score on the Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C16) \> 10.
• Ability to travel for assessment visits.
• Negative urine pregnancy test for people of childbearing potential
• People of childbearing potential must be using an acceptable method of birth control during the study, such as hormonal contraception, intrauterine device, bilateral tubal ligation, partner's documented vasectomy, or complete abstinence from intercourse with childbearing potential, with barrier methods permitted only when used in combination with one of these primary methods.
• BD-I patients must be on stable dose of at least one mood stabilizer (i.e., lithium, valproate, or a mood-stabilizing atypical antipsychotic at least for one month) at the time of enrollment.
• Patients with BD-II who enroll in the study while currently taking a mood stabilizer (including lithium, valproate, or lamotrigine) must have been on a stable dose of that medication for a minimum of one month before enrollment.

You may not qualify if:

• All candidates meeting any of the following criteria at baseline will be excluded from study participation:
• Individuals who cannot understand English will not be enrolled because informed consent, study procedures, and interviews require comprehension of English.
• Inability to provide written, voluntary informed consent due to but not limited to being under conservatorship, guardianship, commitment, or currently undergoing involuntary psychiatric hospitalization.
• Failure to score at least 75% on a 4-item comprehension assessment related to study goals, risks, and benefits
• For BD-I: not having used at least one mood stabilizer (e.g., lithium, valproate, or mood-stabilizing antipsychotics) at a stable dose and within a therapeutically effective antimanic range for a minimum of one month.
• History of treatment-refractory depression, defined as non-response to two or more antidepressant or mood-stabilizing regimens despite adequate dose, duration, and adherence during the current episode.
• Participants with active suicidal ideation, defined as a MADRS item #10 score greater than 4 or a "yes" response to item #4 (ideation with intent) or item #5 (ideation with plan) on the C-SSRS, will be excluded
• A medically serious suicide attempt within the past 6 months, defined as requiring emergency department evaluation, a medical procedure, or admission to a hospital (e.g., internal medicine, cardiology, or ICU)
• Current use of monoamine oxidase inhibitors or use within 14 days following discontinuation of a monoamine oxidase inhibitor
• Presence of mixed symptoms of depression, defined as a YMRS score ≥12
• Current use of any of the study medications (e.g., vortioxetine, or cariprazine) at the time of enrollment (previous use of these medications is acceptable)
• Prior hypersensitivity reaction to any of the study medications or documented non-response to any of the study medications at the maximum therapeutic dose
• A history of seizure disorder
• Recent use of long half-life psychotropic medications, including fluoxetine (in patients with BD and MDD) and long acting injectable forms of antipsychotics (mainly in BD II and MDD) within the past 4 weeks.
• Active psychosis, defined as a YMRS item #8 score \>4 or diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or schizophreniform disorder as determined by structured clinical interview

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Depressive Disorder; Bipolar Disorder

Interventions

Vortioxetine; cariprazine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aysegul Ozerdem, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Deniz Ceylan, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott E. Feeder

CONTACT

507-255-1975; feeder.scott@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: February 17, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 22, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)