Dextromethorphan-Bupropion for Depression

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roger McIntyre

Must not be taking: Antidepressants, MAOIs, CYP inhibitors

Disqualifiers: Bipolar, Psychosis, Substance use, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Must have the ability to speak and read English. This is due to the diagnostic and study assessments being administered in English

I am able to understand and sign a consent form for the study.

I am between 18 and 65 years old.

Exclusion Criteria

I have tried ECT or rTMS in the past, but they did not work for me.

I currently have symptoms of mania or hypomania.

History of non-response to a prior trial of dextromethorphan-bupropion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive open-label DXM/BUP (150 mg orally, twice daily) for 14 days with fMRI scans conducted at baseline and endpoint

2 weeks

2 visits (in-person) for fMRI scans

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dextromethorphan-Bupropion

How Is the Trial Designed?

Group I: Single group, open-label treatment arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Roger McIntyre

Lead Sponsor

Axsome Therapeutics, Inc.

Industry Sponsor

Trials

34

Recruited

11,600+