RecruitingUnipolar DepressionBipolar Depression

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

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

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

Sponsor: Mayo Clinic

✓ Participants must meet all the following criteria to be eligible for the study:
✓ 1. Adult females and males, aged 18-65 years
✓ 2. Must have the capacity to understand study procedures, to comply with them for the entire length of the study, and to provide informed consent.
✓ 3. 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.
✓ 4. Symptom severity score on the Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C16) \> 10.
✓ 5. Ability to travel for assessment visits.
✓ 6. Negative urine pregnancy test for people of childbearing potential
✓ 7. 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.

✕ All candidates meeting any of the following criteria at baseline will be excluded from study participation:
✕ 1. Individuals who cannot understand English will not be enrolled because informed consent, study procedures, and interviews require comprehension of English.
✕ 2. Inability to provide written, voluntary informed consent due to but not limited to being under conservatorship, guardianship, commitment, or currently undergoing involuntary psychiatric hospitalization.
✕ 3. Failure to score at least 75% on a 4-item comprehension assessment related to study goals, risks, and benefits
✕ 4. 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.
✕ 5. 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.
✕ 6. 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
✕ 7. 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)

Rochester

Source: ClinicalTrials.gov · NCT07266545 · last updated 2026-06-22