Actively Recruiting
Dextromethorphan-Bupropion on Striatal Activity in Adults With Major Depressive Disorder
Led by Roger McIntyre · Updated on 2026-04-13
30
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
Sponsors
R
Roger McIntyre
Lead Sponsor
A
Axsome Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will look at how a new medication (dextromethorphan and bupropion taken together in one pill) affects the brain in people with depression. All participants will take the medication for two weeks and have brain scans done. Since people with depression often feel reduced enjoyment in day-to-day activities, our goal is to learn if this treatment can change brain activities in ways that could help improve mood and enjoyment in life.
CONDITIONS
Official Title
Dextromethorphan-Bupropion on Striatal Activity in Adults With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide voluntary, written informed consent before joining the study
- Male or female aged 18 to 65 years
- Diagnosed with major depressive disorder and currently experiencing a moderate to severe major depressive episode without psychotic features
- Montgomery-�c5sberg Depression Rating Scale (MADRS) score of 21 or higher and Clinical Global Impression Scale-Severity (CGI-S) score of 4 or higher
- Fewer than five prior adequate pharmacologic treatments for depression
- Considered safe and eligible for fMRI scans by study staff based on screening and medical documentation
- Access to reliable internet and an internet-based device during the study
- Able to speak and read English
- No exclusion based on prior psychotherapy history
You will not qualify if you...
- Current symptoms of mania, hypomania, or mixed bipolar disorder with Young Mania Rating Scale (YMRS) score over 12
- Current psychosis symptoms or substance use disorder within past 12 months
- History of primary psychotic disorders such as schizophrenia or schizoaffective disorder
- Failure of five or more prior pharmacological treatments for depression
- History of failure with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS)
- Previous treatment with intravenous racemic ketamine or intranasal esketamine for depression
- History of non-response to dextromethorphan-bupropion
- Allergy or hypersensitivity to bupropion
- Current major depressive episode lasting more than 2 years
- Frequent recreational cannabis use or cannabis use disorder
- History of neurological disorders including uncontrolled seizures, recent stroke, major head injuries, aneurysmal vascular disease, arteriovenous malformation, or intracerebral hemorrhage
- Active suicidal or homicidal risk or recent suicide attempts
- Pregnancy, breastfeeding, or intent to become pregnant within 6 months without effective contraception
- Severe liver or kidney problems
- Use of prohibited medications such as antidepressants, MAO inhibitors, or CYP2B6/CYP2D6 inhibitors
- Any medical or psychiatric condition contraindicating fMRI scan (e.g., pacemaker, metal implants, weight over 440 lbs)
- Contraindications to dextromethorphan-bupropion including seizure disorder, eating disorders, abrupt withdrawal from certain substances, MAOI use, or known hypersensitivity to study drugs
- History of serious allergic reactions to bupropion or similar medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brain and Cognition Discovery Foundation
Toronto, Ontario, Canada, M5S1M2
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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