NRX101 for Moderate Bipolar Depression and Suicidal Ideation
Status:
Not yet recruiting
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
Summary
NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression
and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine
and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation.
This study will test the hypothesis that NRX-101 is superior to lurasidone alone (the
standard of care) in maintaining remission from symptoms of depression (primary endpoint) and
suicidal ideation or behavior (declared secondary endpoint) over a six week period of
twice-daily oral dosing.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
NeuroRx, Inc.
Collaborators:
Bracket, Inc. Statistics Collaborative, Inc. Target Health Inc.