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NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation

NCT03396068 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-01-19

No results posted yet for this study

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. NRX-101 has been awarded Fast Track and Breakthrough Therapy Designation by the US Food and Drug Administration. The SevereBD study will test the hypothesis that NRX-101 is superior to lurasidone alone in maintaining remission from symptoms of depression (primary endpoint), clinical relapse (declared secondary 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

  • Target Health Inc.

    collaborator INDUSTRY

  • NeuroRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Brecher, MD · VP, Clinical Development, NeuroRx, Inc.

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
2019-12-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03396068 on ClinicalTrials.gov