Vortioxetine + Bupropion + Cariprazine for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how changes in RNA editing might affect treatment responses in individuals with unipolar and bipolar depression. It tests treatments like vortioxetine and bupropion to determine which best improves depression symptoms. Individuals experiencing major depressive episodes due to major depressive disorder or bipolar disorder, with symptoms confirmed by a doctor, might be suitable candidates. Participants should be able to travel for assessments and must not currently use the study medications. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, aiming to understand how they benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications, like monoamine oxidase inhibitors, vortioxetine, bupropion, and cariprazine, before joining. If you're on a mood stabilizer for BD-I, you must continue it. Check with the trial team about other medications you might need to stop.
What is the safety track record for these treatments?
Research shows that vortioxetine is generally safe and well-tolerated for people with major depressive disorder. Patients usually take doses ranging from 5 to 20 mg per day with few issues. However, there is a warning about an increased risk of suicidal thoughts, especially in younger people.
Bupropion is also approved for treating depression and is considered safe for most people. Common side effects include weight loss, dry mouth, and sweating. Both vortioxetine and bupropion have FDA approval for depression, indicating a strong safety record.
Both medications have been widely used, and their safety is well understood. While some risks exist, they are generally manageable and known.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for depression because they explore innovative combinations of existing medications with RNA editing, a novel method that alters the way cells process genetic information. Unlike standard treatments like SSRIs and SNRIs that mainly target serotonin and norepinephrine, this approach aims to fine-tune the production of proteins involved in mood regulation directly at the RNA level. By pairing vortioxetine, bupropion, and cariprazine with this cutting-edge technique, there's potential for more personalized and effective management of depression, especially for individuals who haven't fully responded to traditional therapies.
What evidence suggests that this trial's treatments could be effective for depression?
Studies have shown that vortioxetine, which participants in this trial may receive, effectively treats major depressive disorder (MDD). It significantly improves depression symptoms and enhances daily functioning. Patients often report improved mood and increased activity levels after taking it. Research also indicates that bupropion, another treatment option in this trial, can reduce depression symptoms, particularly for those experiencing low energy and lack of interest in activities. Both treatments are generally well-tolerated and have helped many people with depression.678910
Who Is on the Research Team?
Deniz Ceylan, MD, PhD
Principal Investigator
Mayo Clinic
Aysegul Ozerdem, MD, PhD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Adults aged 18-65 with unipolar or bipolar depression, not currently in remission, who can understand English and study procedures. They must be on mood stabilizers if diagnosed with BD-I and use effective birth control. Excluded are those with active suicidal ideation, psychosis, substance abuse (except certain cannabis users), unstable medical conditions, seizure disorders, recent serious suicide attempts, hypersensitivity to study meds or treatment-resistant depression.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 8 weeks of treatment with either vortioxetine or bupropion, with dosage titration after 7 days
Augmentation
Participants who do not meet remission criteria enter an additional 8-week augmentation phase
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RNA Editing
Trial Overview
The EDIT-ANDRE trial is studying the effects of Vortioxetine, Bupropion extended release, and Cariprazine on RNA editing in adults with unipolar or bipolar depression. The goal is to see how these changes correlate with the patients' responses to antidepressant treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subjects randomized to the vortioxetine arm will begin 8 weeks of treatment with vortioxetine at 10 mg/day, titrated to 20 mg/day (after 7 days). Subjects who do not meet remission criteria will enter a second 8 week augmentation phase.
Subjects randomized to the bupropion arm will begin 8 weeks of treatment with buproprion extended release at 150 mg/day; titrated to 300 mg/day (after 7 days) Subjects who do not meet remission criteria will enter a second 8 week augmentation phase.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Bupropion: a systematic review and meta-analysis of ...
Bupropion was efficacious in reducing depression scores in 24 of the 27 trials, and, where evaluated, showed comparable levels of efficacy to the other classes ...
Efficacy and Tolerability of Bupropion in Major Depressive ...
In summary, across the six available studies, bupropion improved depressive symptoms and showed modest, low-certainty signals of potential benefit on anxiety.
Extended-Release Bupropion for Patients With Major ...
Conclusion: Bupropion XL was effective and well tolerated in MDD patients with decreased energy, pleasure, and interest.
Dextromethorphan-bupropion (Auvelity) for the Treatment ...
In both long-term studies, remission rates approached 70%, while response rates were greater than 80%. These data suggest that dextromethorphan-bupropion is an ...
Review of Guidelines on Bupropion for Depression
What Did We Do? • To help determine the potential place in therapy for bupropion for the treatment of major depressive disorder (MDD) and ...
Bupropion - StatPearls - NCBI Bookshelf - NIH
Bupropion is an antidepressant medication that has received FDA approval for the treatment of depression and seasonal affective disorder and as an aid for ...
Wellbutrin (bupropion hydrochloride) tablets label
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal.
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imgcdn.mckesson.com
imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9HERPH_BUPROPION_HCL_TAB_100MG_100_BT.pdfSafety Data Sheet Bupropion Hydrochloride Extended- ...
Common side effects reported in studies of major depressive disorder include weight loss, loss of appetite, dry mouth, skin rash, sweating, ringing in the ears,.
Bupropion (oral route) - Side effects & dosage
Bupropion is used to treat major depressive disorder (MDD) and to ... Safety and efficacy have not been established. Geriatric.
Safety profile of sustained-release bupropion in depression
Data from these 3 clinical trials demonstrate the favorable safety profile of bupropion SR in the treatment of depressed outpatients.
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