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New treatment option for Major Depressive Disorder (MDD)
Official title Dextromethorphan-Bupropion on Striatal Activity in Adults With Major Depressive Disorder
ClinicalTrials.gov ID: NCT07523048
What this study is testing
What is Dextromethorphan-Bupropion?
Dextromethorphan-Bupropion is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for major depressive disorder (mdd).
Also referred to as Auvelity, DXM-BUP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Must present with a current MDE with moderate to severe intensity, as determined by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score...
- Lifetime history of less than five prior adequate trials of a pharmacologic treatment for depression.
You likely can't join if
- Currently has symptoms of mania or hypomania or mixed state bipolar disorder, as determined by the Young Mania Rating Scale (YMRS) score greater than...
- Current symptoms of psychosis or a substance use disorder within the past 12 months. Other select secondary psychiatric comorbidities (e.g. anxiety...
- Lifetime history of a primary psychotic disorder (including, but not limited to, schizophrenia or schizoaffective disorder).
- Failure of five or more prior trials of pharmacological treatment for depression.
- Lifetime history of failure of electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS).
- Lifetime history of treatment with intravenous racemic ketamine and/or intranasal esketamine for depression.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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).
- Currently has symptoms of mania or hypomania or mixed state bipolar disorder, as determined by the Young Mania Rating Scale (YMRS) score greater than 12.
- Current symptoms of psychosis or a substance use disorder within the past 12 months. Other select secondary psychiatric comorbidities (e.g. anxiety disorders, trauma-related disorders) will not be excluded according to...
- Lifetime history of a primary psychotic disorder (including, but not limited to, schizophrenia or schizoaffective disorder).
- Failure of five or more prior trials of pharmacological treatment for depression.
- Lifetime history of failure of electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS).
- Lifetime history of treatment with intravenous racemic ketamine and/or intranasal esketamine for depression.
- History of non-response to a prior trial of dextromethorphan-bupropion
- Hypersensitive to bupropion in any formulation
- Duration of current MDE greater than 2 years
- Recreational cannabis use daily, weekly or cannabis use disorder.
- History of neurological disorders (including, but not limited to, uncontrolled seizure disorder, history of stroke within past 12 months, major head injuries, aneurysmal vascular disease [including thoracic and...
- Are actively suicidal (e.g., any suicide attempts within the past 12 months) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia-Suicide Severity...
- Pregnant or breastfeeding women or women who intend to become pregnant in the next 6 months. Patients who are sexually active must agree to use a highly effective contraceptive method (as outlined in section 9.7).
- Current or history of severe hepatic or renal impairment.
- Use of prohibited concomitant medications [e.g., antidepressants, monoamine oxidase inhibitors (MAOIs), CYP2B6 or CYP2D6 inhibitors]. See section 9 for details on contraindications, side effects, prohibited concomitant...
- Any medical or psychiatric history that may exclusionary for fMRI scanning, including but not limited to:
- Cardiac pacemaker
- Surgical aneurysm clips
- Neurostimulator
- Implanted pumps
- Metal fragments in body/eyes
- Pregnancy
- Nitroglycerin patch
- Certain cochlear implants
- Weight\> 440 lbs
- Presence of any contraindications for dextromethorphan-bupropion (DXM/BUP):
- Seizure: Do not use DXM/BUP in patients with a seizure disorder.
- Current or prior diagnosis of bulimia or anorexia nervosa: A higher incidence of seizure was observed in such patients treated with bupropion.
- Undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs: Due to risk of seizure.
- Monoamine Oxidase Inhibitors (MAOIs): Do not use DXM/BUP concomitantly with, or within 14 days of stopping, an MAOI due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and...
- Hypersensitivity: Do not use in patients with known hypersensitivity to dextromethorphan, bupropion, or any component of DXM/BUP. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported with...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.