Actively Recruiting
RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)
Led by Mayo Clinic · Updated on 2026-02-23
120
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to understand how changes in RNA editing relate to treatment response in unipolar and bipolar depression.
CONDITIONS
Official Title
RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Ability to understand and comply with study procedures and provide informed consent
- Current major depressive episodes related to major depressive disorder, bipolar I disorder, or bipolar II disorder confirmed by clinical interview
- Depression symptom severity score greater than 10 on the Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C16)
- Ability to travel for study visits
- Negative pregnancy test for people who can become pregnant
- Use of acceptable birth control methods if of childbearing potential
- Bipolar I participants must be on a mood stabilizer for at least one month at enrollment
You will not qualify if you...
- Inability to understand English
- Unable to provide written informed consent
- Scoring below 75% on comprehension assessment about the study
- Bipolar I participants not using a stable mood stabilizer dose for at least one month
- History of treatment-resistant depression with failure of two or more adequate antidepressant or mood stabilizer treatments
- Active suicidal thoughts or recent serious suicide attempts
- Current or recent use of monoamine oxidase inhibitors
- Mixed depression symptoms with high mania scores
- Current use of study medications at enrollment or history of intolerance or non-response
- History of seizure disorders or conditions lowering seizure threshold
- Poor metabolizer status for certain enzymes or intolerance to related medications
- Recent use of certain long-acting psychotropic drugs
- Active psychosis or diagnosis of schizophrenia-related disorders
- Current drug or alcohol use disorder (except nicotine) without at least 3 months remission
- Positive drug test for illicit substances, except controlled cannabis use with low risk score
- Pregnancy, lactation, trying to conceive, or inadequate contraception use
- Active or unstable medical conditions posing excessive risk
- Significant organ disease or serious laboratory abnormalities
- History of brain injury or gastric bypass surgery
- Diagnosis of cognitive or intellectual disorders
- Current use of electroconvulsive or similar brain stimulation therapies
- Current use of systemic steroids, chemotherapy, radiotherapy, or involuntary psychiatric hospitalization
- High daily doses of benzodiazepines
- Lack of access to smartphones or internet
- For phase 2 (cariprazine add-on): remission based on low depression scores
- Use of strong CYP3A4 inhibitors or inducers affecting cariprazine
- Bipolar I diagnosis with concurrent antipsychotic mood stabilizer use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
S
Scott E. Feeder
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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