NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation
Status:
Recruiting
Trial end date:
2022-04-30
Target enrollment:
Participant gender:
Summary
NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression
and suicidal ideation. NeuroRx has developed a sequential therapy consisting of IV NRX-100
(ketamine HCL) for rapid stabilization of symptoms of depression and suicidal ideation
followed by oral NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for
maintenance of stabilization from symptoms of depression and suicidal ideation. NRX-101 has
been awarded Fast Track and Breakthrough Therapy Designation by the US Food and Drug
Administration. The SevereBD study will test the hypothesis that NRX-101 is superior to
lurasidone alone in maintaining remission from symptoms of depression (primary endpoint),
clinical relapse (declared secondary endpoint), and suicidal ideation or behavior (declared
secondary endpoint) over a six week period of twice-daily oral dosing.