MedTrace Logo

NRX-101 for Bipolar Depression With Subacute Suicidal Ideation

NCT03395392 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-05-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

NRX-101

NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth

DRUG

Lurasidone HCl

Lurasidone HCl will be given twice a day by mouth

Sponsors & Collaborators

  • Prevail Infoworks

    collaborator INDUSTRY

  • NeuroRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Brecher, MD · NRx Pharma

  • Andrew A Nierenberg, MD · Harvard Medical School (HMS and HSDM)

  • Jonathan C Javitt, MD, MPH · NRx Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2024-02-28
Completion
2024-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03395392 on ClinicalTrials.gov