Phase 3
Completed N=327
A Trial of AXS-05 in Patients With Major Depressive Disorder
Source: ClinicalTrials.gov NCT04019704 ↗Enrolled (actual)
327
Serious AEs
0.3%
Results posted
Oct 2022
Primary outcomePrimary: Change in MADRS Total Score From Baseline to Week 6 — 15.91; 12.04 score on a scale — p=0.002
◆ Published Evidence
Highly cited
128citations · ~32 / year
Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI).
Summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
Linked Publications (2)
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Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI).
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Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in MADRS Total Score From Baseline to Week 6 |
15.91; 12.04 | 0.002 sig |
Eligibility Criteria
Key Inclusion Criteria
- Age 18 - 65
- Currently meets DSM-5 criteria for MDD
- Body Mass Index between 18 and 40 kg/m^2, inclusive
Key Exclusion Criteria
- Suicide risk
- History of treatment resistance in current depressive episode
- History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
- Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Data sourced from ClinicalTrials.gov (NCT04019704) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.