Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder
NCT ID: NCT02067793
Last Updated: 2016-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
151 participants
INTERVENTIONAL
2014-03-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Single intravenous injection into the arm on Day 0
NRX-1074 1 mg
NRX-1074 1 mg, intravenous
NRX-1074 1 mg
Single intravenous administration of 1 mg into arm on Day 0
NRX-1074 5 mg
NRX-1074 5 mg, intravenous
NRX-1074 5 mg
Single intravenous injection of 5 mg into the arm on Day 0
NRX-1074 10 mg
NRX-1074 10 mg, intravenous
NRX-1074 10 mg
Single intravenous injection of 10 mg into the arm on Day 0
Interventions
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NRX-1074 1 mg
Single intravenous administration of 1 mg into arm on Day 0
Placebo
Single intravenous injection into the arm on Day 0
NRX-1074 5 mg
Single intravenous injection of 5 mg into the arm on Day 0
NRX-1074 10 mg
Single intravenous injection of 10 mg into the arm on Day 0
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Naurex, Inc, an affiliate of Allergan plc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Naurex, Inc, an affiliate of Allergan plc
Locations
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Pacific Research Partners
Oakland, California, United States
Psychiatric Medicine Associates
Skokie, Illinois, United States
University of Kansas School of Medicine Clinical Trial Unit
Wichita, Kansas, United States
Boston Clinical Trials, Inc.
Roslindale, Massachusetts, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
Mount Sinai School of Medicine
Elmsford, New York, United States
New York State Psychiatric Institute
New York, New York, United States
Lindner Center of HOPE
Mason, Ohio, United States
Research Strategies Memphis
Memphis, Tennessee, United States
Research Across America
Dallas, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Psychiatric Alliance of the Blue Ridge
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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NRX1074-C-201
Identifier Type: -
Identifier Source: org_study_id
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