Shawn Alter

2 papers in the library · publishing 2023

Papers

AXS-05 (DEXTROMETHORPHAN-BUPROPION) Improves Depressive Symptoms and Functioning in Patients With One Prior Treatment Failure: Results From the Evolve Long-Term, Open Label Study

CNS Spectrums April 1, 2023 Amanda Jones, Caroline Streicher, Shawn Alter et al.

In patients with major depressive disorder who had not improved after one prior antidepressant in the current episode, treatment with AXS-05 (dextromethorphan HBr 45 mg-bupropion HCl 105 mg) led to rapid and sustained improvements in depression and functioning. Mean scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) dropped by 9.1 points at one week, 13.3 points at two weeks, and 20.4 points at six weeks. Remission (MADRS score of 10 or less) was achieved by 5.7% of patients at one week, 16.2% at two weeks, and 46.0% at six weeks. Improvements in functioning were seen starting at one week and were maintained at 12 months. Common side effects included COVID-19 infection, nausea, headache, dry mouth, insomnia, and dizziness.

DOI: 10.1017/s1092852923001840

Rapid Antidepressant Effects and MADRS Item Improvements With AXS-05 (DEXTROMETHORPHAN-BUPROPION), an Oral NMDA Receptor Antagonist in Major Depressive Disorder: Results From Two Randomized Double-Blind, Controlled Trials

CNS Spectrums April 1, 2023 Amanda Jones, Caroline Streicher, Shawn Alter et al.

AXS-05 (dextromethorphan-bupropion) is an oral NMDA receptor antagonist being developed for major depressive disorder. In two double-blind, randomized, controlled 6-week trials, AXS-05 showed rapid antidepressant effects. In the placebo-controlled GEMINI trial (327 participants), AXS-05 was superior to placebo on depressive symptom improvement starting at Week 1, with greater improvement on the MADRS scale (7.3 vs. 4.9 points), higher response rates (15% vs. 7%), and by Week 2, higher remission rates (17% vs. 8%). In the ASCEND trial (80 participants) comparing AXS-05 to bupropion alone, AXS-05 was superior from Week 2 on MADRS improvement (12.5 vs. 7.8 points) and remission (26% vs. 3%). Common adverse events included dizziness, nausea, headache, diarrhea, somnolence, and dry mouth.

DOI: 10.1017/s1092852923002158