RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMayo Clinic
About this trial
The purpose of this research is to understand how changes in RNA editing relate to treatment response in unipolar and bipolar depression.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vortioxetine
- Cariprazine (Augmentation Phase)
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov