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NRX-1074

Phase 2

Major Depressive Disorder | Small molecule | Other |AbbVie Inc.|Last Updated: Mar 17, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment166

FDA Designations

No designations recorded

Clinical trial landscape

NRX-1074 · 3 trials · 2 indications

Phase 2 1Phase 1 2
NCT02067793Study of Intravenous NRX-1074 in Patients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED151 Analytics
PHASE2COMPLETED
Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the mean change from baseline in Hamilton Depression Rating Scale 17 (HDRS-17) score for each NRX-1074 dose group versus the placebo group's mean change
Day 1, Day 3, Day 7, Day 14

Change in Hamilton Depression Rating Scale HDRS-17

Number of participants with adverse events as a measure of safety and tolerability
28 days following study drug dose

Observed side effects and changes in laboratory values

Observed and laboratory-confirmed safety
28 days

Secondary Endpoints

Change in Brief Psychiatric Rating Scale positive symptoms (BPRS+) scale
Day 1
Change in Clinician Administered Dissociative States Scale (CADSS)
Day 1
Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo
NRX-1074 1 mgEXPERIMENTALNRX-1074 1 mg, intravenous
NRX-1074 5 mgEXPERIMENTALNRX-1074 5 mg, intravenous
NRX-1074 10 mgEXPERIMENTALNRX-1074 10 mg, intravenous
Drug: PlaceboPLACEBO_COMPARATORSingle oral administration on Day 1
Drug: NRX-1074 375 mgEXPERIMENTALSingle oral administration on Day 1
Drug: NRX-1074 500 mgEXPERIMENTALSingle oral administration on Day 1
Drug: NRX-1074 750 mgEXPERIMENTALSingle oral administration on Day 1
NRX-1074, 1 mgEXPERIMENTAL1 mg IV
NRX-1074, 5 mgEXPERIMENTAL5 mg IV
NRX-1074, 10 mg IVEXPERIMENTAL10 mg
NRX-1074, 50 mg IVEXPERIMENTAL50 mg
NRX-1074, 25 mg POEXPERIMENTAL25 mg
NRX-1074, 125 mg POEXPERIMENTAL125 mg

Interventions

NameTypeDescription
NRX-1074 1 mgDRUGSingle intravenous administration of 1 mg into arm on Day 0
PlaceboDRUGSingle intravenous injection into the arm on Day 0
NRX-1074 5 mgDRUGSingle intravenous injection of 5 mg into the arm on Day 0
NRX-1074 10 mgDRUGSingle intravenous injection of 10 mg into the arm on Day 0
NRX-1074 375 mgDRUGSingle oral administration of 375 mg consumption on Day 1
NRX-1074 500 mgDRUGSingle oral administration of 500 mg consumption on Day 1
NRX-1074 750 mgDRUGSingle oral administration of 750 mg consumption on Day 1
NRX-1074DRUGSingle IV or PO administration
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Male and female subjects * Aged 18 to 65 years * Meets Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD) * Current episode has lasted ≥ 8 weeks before Screening * HDRS-17 score ≥ 21 before beginning the wa...

Countries:United States
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