Peer-reviewed and published results

from two Phase II

clinical studies have demonstrated a

significant decline in symptoms of

depression following administration of

D-cycloserine, one of

the active ingredients in NRX-101 (CycluradTM).

© 2016 NeuroRx, Inc.

*This drug is investigational and not approved by the US FDA

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Clinical Data

Peer-reviewed and published results from two Phase II clinical studies have demonstrated a significant decline in symptoms of depression following administration of D-cycloserine, one of the active ingredients in NRX-101 (Cyclurad™).

 

Findings from one of these studies, published in the Journal of Clinical Psychiatry, found that bipolar patients who were already receiving a 5-HT2a antagonist demonstrated more than a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation when ketamine and D-cycloserine were added to their treatment regimen. The therapeutic effect for these patients was sustained for eight weeks or longer.1

 

Findings from the other study were published in the International Journal of Neuropsychopharmacology in 2013. These trial results provided the first proof of concept evidence that high doses of D-cycloserine induce antidepressant effects and reduces the severity of major depressive disorder.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