Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dextromethorphan-Bupropion · 1 trial · 1 indication
Change from baseline (Day 1) to endpoint (Day 14) in task-evoked blood oxygen level-dependent (BOLD) signal within striatal regions of interest during the Effort Expenditure for Rewards Task (EEfRT), as measured by functional magnetic resonance imaging (fMRI).
| Arm | Type | Description |
|---|---|---|
| Single group, open-label treatment arm | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Dextromethorphan-Bupropion | DRUG | The generic name of the study drug is dextromethorphan-bupropion (150 mg), which is an oral, extended-release tablet comprised of 45 mg dextromethorphan HBr and 105 mg bupropion HCl. The brand name of this study drug is Auvelity. Eligible participants that provide written informed consent will be assigned to a single-arm, open-label treatment group, for a treatment period of 14 days. Participants in this treatment group will be asked to take one oral dextromethorphan-bupropion extended-release tablet once daily for Days 1-3 of the treatment period. Participants will then be asked to increase their dose to one oral dextromethorphan-bupropion extended-release tablet twice daily, for Days 4-14 of the treatment period. |
Inclusion Criteria: 1. Capable of providing voluntary, written, informed consent prior to study enrollment. 2. Male or female between the age of 18 to 65 years, inclusive. 3. Meets DSM-5-TR criteria for a Major Depressive Disorder and currently experiencing a Major Depressive Episode (MDE) without ...
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