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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Vortioxetine
DrugVortioxetine, once daily, for 8 weeks
Cariprazine (Augmentation Phase)
DrugParticipants 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: VortioxetineExperimental treatment 2 interventions
Trial outcomes
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).
Time frame
Baseline, Week 2, Week 8, Week 10, Week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov