Auvelity (bupropion/dextromethorphan) / Axsome Therap 
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 1 Disease   5 Trials   5 Trials   185 News 


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  • ||||||||||  Review, Journal:  Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status. (Pubmed Central) -  Jan 7, 2022   
    Furthermore, to date, most have demonstrated relatively modest effects compared with (R,S)-ketamine and esketamine, though some have shown more favorable characteristics. Of these novel agents, the most promising, and the ones for which the most evidence exists, appear to be those targeting ionotropic glutamate receptors.
  • ||||||||||  Auvelity (bupropion/dextromethorphan) / Axsome Therap
    Trial completion:  Mechanistic Evaluation of Response in TRD (MERIT) (clinicaltrials.gov) -  Sep 5, 2021   
    P2,  N=44, Completed, 
    AXS-05 is a novel oral NMDA receptor antagonist with multi-modal activity being developed for the treatment of CNS disorders, including TRD and MDD. Recruiting --> Completed
  • ||||||||||  Auvelity (bupropion/dextromethorphan) / Axsome Therap
    Enrollment status:  Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE) (clinicaltrials.gov) -  Jul 30, 2021   
    P2,  N=150, Enrolling by invitation, 
    Recruiting --> Completed Recruiting --> Enrolling by invitation
  • ||||||||||  Spravato (esketamine intranasal) / J&J, bupropion/dextromethorphan (AXS-05) / Axsome Therap, rapastinel (GLYX-13) / AbbVie
    [VIRTUAL] Efficacy of Non-Ketamine Glutamatergic Agents in the Treatment of Major Depressive Disorder – the Promise, the Pitfalls, and the Evidence () -  Apr 13, 2021 - Abstract #ASCP2021ASCP_189;    
    Finally, we will also discuss the potential efficacy for the most widely studied glutamatergic compound, intranasal esketamine, as a potential maintenance agent in subjects who have responded to IV acute phase racemic ketamine. Learning Objectives To evaluate the efficacy of novel, non-ketamine, glutamatergic agents for the treatment of Major Depressive Disorder To compare the efficacy IV racemic ketamine with intranasal esketamine in the acute and long-term treatment of Major Depressive Disorder
  • ||||||||||  bupropion/dextromethorphan (AXS-05) / Axsome Therap
    [VIRTUAL] Effects of AXS-05 on Patient Reported Depressive Symptoms in Major Depressive Disorder- Results from the GEMINI Trial () -  Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1051;    
    Percentages of patients reporting very much/much improved on the PGI-I were statistically significant for AXS-05 vs. placebo beginning at Week 1 (13.5% vs. 4.9%, p=0.008) and at every timepoint thereafter: Week 2 (30.0% vs. 18.2%, p=0.015), Week 3 (43.2% vs. 18.2%, p<0.001), Week 4 (46.9% vs. 28.0%, p=0.001), and Week 6 (47.2% vs. 31.3%, p=0.007). CONCLUSIONS : Patients self-reported that treatment with AXS-05 resulted in rapid, substantial, and statistically significant improvements in depressive symptoms consistent with clinician-reported measures (MADRS, CGI-I), starting at Week 1 and sustained through Week 6.
  • ||||||||||  Auvelity (bupropion/dextromethorphan) / Axsome Therap
    Trial completion date, Trial primary completion date:  Mechanistic Evaluation of Response in TRD (MERIT) (clinicaltrials.gov) -  Mar 26, 2021   
    P2,  N=50, Recruiting, 
    The novel mechanisms of action of AXS-05 may contribute to these rapid antidepressant effects. Trial completion date: Jun 2021 --> Sep 2021 | Trial primary completion date: Jun 2021 --> Sep 2021
  • ||||||||||  Auvelity (bupropion/dextromethorphan) / Axsome Therap
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  Open-Label Safety Study of AXS-05 in Subjects With Depression (clinicaltrials.gov) -  Dec 17, 2020   
    P3,  N=876, Completed, 
    Trial completion date: Jun 2021 --> Sep 2021 | Trial primary completion date: Jun 2021 --> Sep 2021 Recruiting --> Completed | N=300 --> 876 | Trial completion date: Jul 2020 --> Oct 2020 | Trial primary completion date: Jul 2020 --> Oct 2020
  • ||||||||||  Auvelity (bupropion/dextromethorphan) / Axsome Therap
    Trial completion:  ADVANCE: Addressing Dementia Via Agitation-Centered Evaluation (clinicaltrials.gov) -  Oct 7, 2020   
    P2/3,  N=366, Completed, 
    Active, not recruiting --> Completed Recruiting --> Completed