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Study identifier: NCT03395392 Synced from ClinicalTrials.gov · July 28, 2026
● Completed

NRX-101 for Bipolar Depression With Subacute Suicidal Ideation

Condition: Bipolar Depression · Suicidal Ideation and Behavior  ·  Sponsor: NeuroRx, Inc.

PhasePhase 2/Phase 3
Planned participants74
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

NMDA antagonist drugs have shown 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 (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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Locations (14)

Science 37Culver City, California, United States
San Marcus Research Clinic, Inc.Miami Lakes, Florida, United States
ACMRAtlanta, Georgia, United States
iResearch Atlanta, LLCDecatur, Georgia, United States
iResearch SavannahSavannah, Georgia, United States
CBH HealthGaithersburg, Maryland, United States
Omaha Insomnia and Psychiatric ServicesOmaha, Nebraska, United States
Dent Neurologic InstituteAmherst, New York, United States
Peace Health Medical GroupEugene, Oregon, United States
University of Texas Health AustinAustin, Texas, United States
Roots Behavioral HealthAustin, Texas, United States
JPS HealthFort Worth, Texas, United States

+ 2 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT03395392