Two-Week, Open-Label, Exploratory Neuroimaging Study Evaluating the Effect of Dextromethorphan-HBr Bupropion-HCl on Striatal Reactivity During Reward Processing in Adults With Major Depressive Disorder
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.
• Capable of providing voluntary, written, informed consent prior to study enrollment.
• Male or female between the age of 18 to 65 years, inclusive.
• Meets DSM-5-TR criteria for a Major Depressive Disorder and currently experiencing a Major Depressive Episode (MDE) without psychotic features. Diagnosis will be confirmed using the Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician or trained research study staff.
• Must present with a current MDE with moderate to severe intensity, as determined by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score equal to or greater than 21 and Clinical Global Impression Scale-Severity (CGI-S) total score equal to or greater than 4.
• Lifetime history of less than five prior adequate trials of a pharmacologic treatment for depression.
• Deemed safe and eligible by the study doctor, study investigator, trained research staff and/or fMRI technicians/trained staff to participate in fMRI scans according to intake screening form and (if applicable) related medical documentation (e.g., doctor notes, medical charts documenting medical/dental implants, pacemakers).
• Access to reliable internet for the entire study period and an internet-based device (i.e., a smartphone, laptop, desktop or tablet).
• Must have the ability to speak and read English. This is due to the diagnostic and study assessments being administered in English.
• Note: there is no inclusion/exclusion based on prior history of manual-based psychotherapy (e.g., cognitive behavioural therapy).