This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc
ClinicalTrials.gov Identifier:
NCT02067793
First received: February 18, 2014
Last updated: February 18, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to evaluate the efficacy and safety of NRX-1074 following a single intravenous dose in subjects with major depressive disorder.

Condition Intervention Phase
Major Depressive Disorder Drug: NRX-1074 1 mg Drug: Placebo Drug: NRX-1074 5 mg Drug: NRX-1074 10 mg Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-Blind, Multiple-Dose Level, Placebo Controlled, Single Intravenous Dose, Parallel Efficacy and Safety Study of NRX-1074 in Subjects With Major Depressive Disorder

Further study details as provided by Naurex, Inc:

Primary Outcome Measures:
  • 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 [ Time Frame: Day 1, Day 3, Day 7, Day 14 ]
    Change in Hamilton Depression Rating Scale HDRS-17


Secondary Outcome Measures:
  • Change in Brief Psychiatric Rating Scale positive symptoms (BPRS+) scale [ Time Frame: Day 1 ]
  • Change in Clinician Administered Dissociative States Scale (CADSS) [ Time Frame: Day 1 ]
  • Change in Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Day 1 ]

Enrollment: 151
Study Start Date: March 2014
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Single intravenous injection into the arm on Day 0
Other Name: NRX-1074 IV single dose
Experimental: NRX-1074 1 mg
NRX-1074 1 mg, intravenous
Drug: NRX-1074 1 mg
Single intravenous administration of 1 mg into arm on Day 0
Other Name: NRX-1074 IV single dose
Experimental: NRX-1074 5 mg
NRX-1074 5 mg, intravenous
Drug: NRX-1074 5 mg
Single intravenous injection of 5 mg into the arm on Day 0
Other Name: NRX-1074 IV single dose
Experimental: NRX-1074 10 mg
NRX-1074 10 mg, intravenous
Drug: NRX-1074 10 mg
Single intravenous injection of 10 mg into the arm on Day 0
Other Name: NRX-1074 IV single dose

Detailed Description:
NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy in animal models of affective disorders including major depressive disorder. The purpose of this study is to evaluate efficacy and safety of NRX-1074 at dose levels that are predicted by comparison of human and animal pharmacokinetics to be efficacious.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 washout of all current antidepressant agents and/or adjuvant agents
  • HDRS-17 score ≥ 21 at Baseline (after 14 days of washout of current antidepressant agents)
  • Female subjects of childbearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (eg oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study. Female subjects may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post-menopausal
  • Male subjects and their female sexual partner should use an acceptable method of birth control during the study
  • Clinical laboratory values < 2 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator and Naurex medical monitor
  • Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
  • Based on both the investigator and Naurex medical monitor's clinical judgment, subjects with eating disorders, obsessive compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), and generalized anxiety disorders secondary to major depressive episodes are permitted

Exclusion Criteria:

  • Axis I diagnosis of delirium, dementia, dysthymia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder (anorexia or bulimia nervosa), obsessive-compulsive disorder, panic disorder, agoraphobia, social phobia, attention-deficit hyperactivity disorder (ADHD), or PTSD
  • A clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
  • Experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode; lifetime history of psychosis
  • Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or a history of seizures or strokes
  • Currently hospitalized or residing in an in-patient facility during the study participation
  • Substance abuse within the last 12 months, including greater than or equal to 5 units of alcohol per day where 1 unit = 1/2 pint of beer, 1 glass of wine, or 1 oz. of spirits consumed most weeks or in the opinion of the investigator
  • Allergy or intolerance to current antidepressant or other current medications
  • Participation in any clinical trial of an investigational product or device within 30 days of enrollment in this trial
  • Positive screen for drugs of abuse: cocaine, marijuana, PCP, ketamine, opioid or other agent that in the opinion of the investigator is being abused
  • Have received electroconvulsive therapy, transcranial magnetic stimulation (TMS), or vagal nerve stimulation (VNS) for the current depressive episode
  • Post current (past 6 months) suicide risk based on administration of the C-SSRS and the investigator's clinical judgment
  • Human immunodeficiency virus (HIV) infection (based on the HIV-1 & HIV-2 antibody screen) or other ongoing infectious disease
  • Females or female partners of male subjects who are currently pregnant or planning to become pregnant during the course of the study. Women who are breastfeeding
  • Currently taking prescription (psychiatric treatments, antidepressant treatments) or over-the-counter medications including herbal therapies to treat their MDD or conditions secondary to their period following study drug dosing. Dextromethorphan or tramadol since these are serotonin uptake inhibitors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02067793

Locations
United States, California
Pacific Research Partners
Oakland, California, United States, 94612
United States, Illinois
Psychiatric Medicine Associates
Skokie, Illinois, United States, 60076
United States, Kansas
University of Kansas School of Medicine Clinical Trial Unit
Wichita, Kansas, United States, 67214
United States, Massachusetts
Boston Clinical Trials, Inc.
Roslindale, Massachusetts, United States, 02131
United States, Missouri
Psychiatric Care and Research Center
O'Fallon, Missouri, United States, 63368
United States, New York
Mount Sinai School of Medicine
Elmsford, New York, United States, 10523
New York State Psychiatric Institute
New York, New York, United States, 10032
United States, Ohio
Lindner Center of HOPE
Mason, Ohio, United States, 45040
United States, Tennessee
Research Strategies Memphis
Memphis, Tennessee, United States, 38119
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
United States, Virginia
Psychiatric Alliance of the Blue Ridge
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Naurex, Inc
Investigators
Study Director: Medical Director Naurex Inc, an affiliate of Allergan plc
  More Information

Responsible Party: Naurex, Inc
ClinicalTrials.gov Identifier: NCT02067793     History of Changes
Other Study ID Numbers: NRX1074-C-201
Study First Received: February 18, 2014
Last Updated: February 18, 2016

Keywords provided by Naurex, Inc:
NRX-1074
NMDA Receptor Modulator
Major Depressive Disorder
Glycine site modulator

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 21, 2017