Dextromethorphan-Bupropion for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new medication that combines dextromethorphan and bupropion to assess its effects on the brain in people with depression. Participants will take the medication daily for two weeks and undergo brain scans to determine if it improves mood and enjoyment in life. It is suitable for individuals who have experienced depression and have had fewer than five unsuccessful treatments with medications. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you do not take certain medications, such as antidepressants, monoamine oxidase inhibitors (MAOIs), and some other specific drugs. You may need to stop these medications before participating, but the protocol does not specify a general requirement to stop all current medications.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the combination of dextromethorphan and bupropion is generally safe and well-tolerated. Studies have found significant improvements in depression symptoms among people taking this medication. However, about one-third of participants reported serious side effects, slightly more than those taking bupropion alone.
Despite these concerns, the FDA has already approved this treatment for other uses, indicating a reasonable level of safety. Prospective participants should discuss potential risks and benefits with their healthcare provider before joining a trial.12345Why do researchers think this study treatment might be promising for depression?
Dextromethorphan-Bupropion is unique because it brings together two active ingredients that have shown potential for treating depression in a novel way. Unlike typical antidepressants that mainly affect serotonin levels, this combination targets both the NMDA receptor through dextromethorphan and the norepinephrine-dopamine reuptake pathway through bupropion. Researchers are excited about this treatment because it could offer faster relief from depressive symptoms, potentially showing effects in just days rather than weeks. Additionally, by engaging multiple pathways in the brain, it may offer benefits to patients who haven't responded well to traditional antidepressants.
What evidence suggests that this treatment might be an effective treatment for depression?
Research has shown that combining dextromethorphan and bupropion can significantly improve depression symptoms. In some studies, up to 70% of participants experienced complete relief, and over 80% showed improvement. Many reported feeling better as early as the first week of treatment. This combination alters brain chemicals related to mood, providing rapid antidepressant effects. Overall, it seems to be a promising option for treating depression. Participants in this trial will take daily oral dextromethorphan-bupropion (DXM/BUP) extended-release tablets in an open-label manner for a 14-day treatment period.12467
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 who speak English, have moderate to severe major depression (not psychotic or bipolar), and are able to undergo brain scans. Participants must not be pregnant, actively suicidal, have certain medical conditions (like seizures), or failed multiple prior treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive open-label DXM/BUP (150 mg orally, twice daily) for 14 days with fMRI scans conducted at baseline and endpoint
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dextromethorphan-Bupropion
Trial Overview
The study tests a new pill combining dextromethorphan and bupropion in people with major depression. All participants take the medication daily for two weeks while researchers monitor changes in their brain activity using scans.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants who meet eligibility criteria and provide informed consent will be assigned to receive daily oral dextromethorphan-bupropion (DXM/BUP) extended release tablets in an open-label manner for a 14-day treatment period. No randomization or masking will be applied, and all participants and researchers will be aware of the study treatment allocation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roger McIntyre
Lead Sponsor
Axsome Therapeutics, Inc.
Industry Sponsor
Citations
Efficacy and safety of dextromethorphan-bupropion ...
The findings indicate superior efficacy of the dextromethorphan-bupropion combination, with remission rates of 46.5% and 39.5%, compared to 16.2 ...
Efficacy and safety of dextromethorphan–bupropion ... - PMC
The findings indicate superior efficacy of the dextromethorphan–bupropion combination, with remission rates of 46.5% and 39.5%, compared to 16.2 ...
Efficacy of Dextromethorphan-Bupropion Versus SSRIs in ...
The study aims to compare the antidepressant effects of a dextromethorphan-bupropion combination versus standard SSRI therapy in adult patients with major ...
Dextromethorphan‐bupropion shows efficacy in two ...
Dextromethorphan-bupropion resulted in significant improvement in depressive symptoms compared with bupropion in the Phase 2 study and compared ...
Clinical Data with Dextromethorphan-bupropion
The first (GEMINI) showed that the combo was more effective than placebo in reducing depression symptoms over 6 weeks, with separation seen as early as 1 week.
Efficacy and Safety of AXS-05 (Dextromethorphan ...
Treatment with dextromethorphan-bupropion (AXS-05) resulted in significant improvements in depressive symptoms compared to placebo starting 1 week after ...
Effect of AXS-05 (Dextromethorphan-Bupropion) in Major ...
At week 6, clinical response was achieved by 60.5% of patients in the dextromethorphan-bupropion, compared with 40.5% in the bupropion group ( ...
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