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Clinical trialNCT03395392CompletedPhase 2/PHASE3Interventional

NRX-101 for Bipolar Depression With Subacute Suicidal Ideation

SponsorNeuroRx, Inc.Enrollment74Bipolar DepressionSuicidal Ideation and Behavior
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Science 37

    Culver City, California, United States

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, United States

  • Acmr

    Atlanta, Georgia, United States

  • Iresearch Atlanta, Llc

    Decatur, Georgia, United States

  • Iresearch Savannah

    Savannah, Georgia, United States

  • Cbh Health

    Gaithersburg, Maryland, United States

  • Omaha Insomnia and Psychiatric Services

    Omaha, Nebraska, United States

  • Dent Neurologic Institute

    Amherst, New York, United States

  • Peace Health Medical Group

    Eugene, Oregon, United States

  • Roots Behavioral Health

    Austin, Texas, United States

  • University of Texas Health Austin

    Austin, Texas, United States

  • Jps Health

    Fort Worth, Texas, United States

  • Houston Mind and Brain

    Houston, Texas, United States

  • Health Texas

    Richmond, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Lurasidone →NRX-101
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
12 May 2022
Primary completion
28 Feb 2024
Completion
30 Mar 2024
Last update posted
8 May 2024
Registered enrollment
74
Registry id
NCT03395392
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.