Peer-reviewed and published results

from two Phase 2

clinical studies have demonstrated a

significant reduction in symptoms of

depression when

D-cycloserine (one of

the active ingredients in NRX-101) was added to their existing antidepressant medication.

© 2016 NeuroRx, Inc.

*These drugs are investigational and not approved by the US FDA

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Clinical Data

Peer-reviewed and published results from two Phase 2 clinical studies have demonstrated a significant reduction in symptoms of depression when D-cycloserine (one of the active ingredients in NRX-101)  was added to their existing antidepressant medication.

 

Findings from one of these studies was published in the Journal of Clinical Psychiatry in 2015. In this study, patients with Bipolar Depression, who were already receiving a 5-HT2a antagonist, received a single infusion of IV ketamine followed by daily, oral D-cycloserine. Results showed a >50% reduction in symptoms of depression and a 75% reduction in suicidal ideation. The therapeutic effect for these patients was sustained for eight weeks or longer.1

 

Findings from the second study were published in the International Journal of Neuropsycho-pharmacology in 2013. These trial results provided the first proof-of-concept evidence in Treatment-Resistant Major Depressive Disorder. In this study, high doses of D-cycloserine, when added to existing antidepressant medication, led to an improvement in depression symptoms.2

 

Additionally, preclinical data showing that the combination of lurasidone (and other 5HT2a antagonists) and D-cycloserine led to a significant reduction in akathisia compared to control and to lurasidone alone. These findings are described in detail in several US and ex-US patent filings. Akathisia is defined as a state of agitation, distress, and restlessness that is an occasional side-effect of antipsychotic and antidepressant drugs.

 

  1. Kantrowitz, et al: J Clinical Psychiatry 2015; 76(6): 737-738
  2. Haresco-Levy, et al: International Journal of Neuropsychopharmachology 2013: 16.3: 501-506