NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression
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. This study
will test the hypothesis that that NRX-100 is superior to placebo in achieving rapid
reduction in symptoms of depression and suicidal ideation in patients with Severe Bipolar
Depression and Acute Suicidal Ideation or Behavior within 24 hours of administration.
Phase:
Phase 3
Details
Lead Sponsor:
NeuroRx, Inc.
Collaborators:
Bracket, Inc. Stats Collaborative Target Health Inc.