RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether changes in RNA editing are linked to how well depression treatment works. RNA editing changes messages inside cells. The study is for adults ages 18–65 who currently have major depression or depression linked to bipolar I or II disorder.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–65 years old.
  • Be able to understand the study, follow its steps, and freely agree to join.
  • Have a current major episode of depression linked to major depressive disorder or bipolar I or II disorder, confirmed by a study-approved interview.
  • Score above 10 on the QIDS-C16 depression symptom scale.
  • Be able to travel to study visits.
  • If you could become pregnant, have a negative urine pregnancy test.
  • If you could become pregnant, use an approved birth control method during the study. Barrier methods, such as condoms, cannot be used alone.
  • For bipolar I, take a steady dose of a mood-stabilizing medicine for at least one month. For bipolar II, this one-month rule applies if you already take a mood stabilizer.

Who can't join

  • Cannot understand English, freely give written consent, or score at least 75% on the study understanding check; or lack access to a smartphone or the internet.
  • Two or more properly used depression treatments have not worked during this episode; serious current suicidal thoughts; or a suicide attempt needing emergency or hospital care in the past 6 months.
  • Mixed depression and mania symptoms, active psychosis (trouble knowing what is real), certain psychotic disorders, or another mental health condition that is a main reason for treatment.
  • A current drug or alcohol use disorder, other than nicotine, unless fully in remission for at least 3 months; or a positive illegal-drug test. Cannabis users may qualify based on an added screening test.
  • Pregnant, breastfeeding, trying to become pregnant, or not using required birth control; seizures, certain brain injuries, serious thinking problems, Roux-en-Y gastric bypass, or serious or unstable health problems. Certain abnormal blood tests, high blood pressure, or a fast heart rate also exclude people.
  • Current study medicines, a past allergic reaction to them, or failure to improve on their highest treatment dose; recent MAO inhibitor antidepressants, fluoxetine, or long-acting antipsychotic shots; opioid agonist medicines; high daily doses of certain calming medicines; or failure to meet bipolar I mood-stabilizer rules.
  • Current electrical, magnetic, or implanted-device brain treatments; steroids that affect the whole body; chemotherapy; or radiation treatment. Some other medicines must have had no start or major dose change in the past 4 weeks.
  • For phase 2, which adds cariprazine: depression symptoms have mostly cleared, use of certain medicines or supplements that interact with cariprazine, or bipolar I treated with an antipsychotic as a mood stabilizer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria 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. 8. 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. Exclusion Criteria 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) 8. Current use of monoamine oxidase inhibitors or use within 14 days following discontinuation of a monoamine oxidase inhibitor 9. Presence of mixed symptoms of depression, defined as a YMRS score ≥12 10. 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) 11. Prior hypersensitivity reaction to any of the study medications or documented non-response to any of the study medications at the maximum therapeutic dose 12. A history of seizure disorder 13. 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. 14. 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 15. Current drug or alcohol use disorder (excluding nicotine); full remission for at least 3 months is required for eligibility 16. Positive toxicology screen for illicit substances (e.g., cocaine, methamphetamine, illegal opiates). Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included in the study only if they take the CUDIT-R and score a 12 or less. 17. Individuals who are pregnant, lactating, trying to conceive, or not using adequate contraception (e.g., hormonal contraception, intrauterine device, tubal ligation, or condoms) 18. Any active or unstable medical condition judged by the principal investigator to confer excessive risk 19. Clinically significant laboratory abnormality, uncontrolled hypertension (blood pressure \>160/100 mmHg), or tachycardia (heart rate \>110 bpm) 20. Significant renal, hepatic, or cardiac disease; malignancy; autoimmune disease; or chronic kidney disease \> stage IIIa (estimated GFR \< 60 mL/min/1.73 m²) 21. History of traumatic brain injury defined as loss of consciousness for 5 minutes and related to a trauma event 22. Gastric bypass, specifically Roux-en-Y 23. Clinical current diagnosis of delirium, encephalopathy, intellectual disability or cognitive disorder (mild or major neurocognitive disorder) 24. Currently receiving electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) as acute or maintenance treatment 25. Current use of systemic steroids, chemotherapy, and radiotherapy 26. Daily use of lorazepam (Ativan) \>4 mg/day, or equivalent doses of other benzodiazepines (e.g., clonazepam \>1 mg, alprazolam \>2 mg, diazepam \>20 mg) 27. No access to smartphones, internet 28. Other Axis I or II diagnoses, by clinical judgments that are the current reason for treatment evaluation or play a large part of the current symptom presentation 29. Ongoing treatment with opioid agonists will constitute an exclusion criterion. In contrast, other ongoing treatments, such as alcohol relapse prevention agents or ADHD pharmacotherapy, will not be considered exclusion criteria, provided that no treatment initiation or significant dose adjustment has occurred within the past 4 weeks. All candidates meeting any of the following criteria at baseline will be excluded from the Phase 2 (cariprazine add-on) of the study: 1. Meeting symptomatic remission criteria based on MADRS (≤ 10). 2. Current use of a strong or moderate CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, fluconazole, or verapamil) strong or moderate CYP3A4 inducer (e.g., carbamazepine, rifampin, phenytoin, or St. John's Wort), due to potential pharmacokinetic interactions with cariprazine. 3. Diagnosis of BD-I with concurrent use of an antipsychotic agent as a mood stabilizer.

Study sites (1)

MN

  • Mayo Clinic in Rochester · Rochester, MN 55905Scott E. Feeder · Study contact · 507-255-1975Aysegul Ozerdem, MD, PhD · Principal investigatorDeniz Ceylan, MD, PhD · Principal investigatorMore trials in Rochester