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

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ClinicalTrials.gov Identifier: NCT02067793
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Tracking Information
First Submitted Date  ICMJE February 18, 2014
First Posted Date  ICMJE February 20, 2014
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
  • 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-17 [ Time Frame: Day 1, 3, 7, 14 ]
Change History Complete list of historical versions of study NCT02067793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder
Official Title  ICMJE 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
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: NRX-1074 1 mg
    Single intravenous administration of 1 mg into arm on Day 0
    Other Name: NRX-1074 IV single dose
  • Drug: Placebo
    Single intravenous injection into the arm on Day 0
    Other Name: NRX-1074 IV single dose
  • Drug: NRX-1074 5 mg
    Single intravenous injection of 5 mg into the arm on Day 0
    Other Name: NRX-1074 IV single dose
  • Drug: NRX-1074 10 mg
    Single intravenous injection of 10 mg into the arm on Day 0
    Other Name: NRX-1074 IV single dose
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: NRX-1074 1 mg
    NRX-1074 1 mg, intravenous
    Intervention: Drug: NRX-1074 1 mg
  • Experimental: NRX-1074 5 mg
    NRX-1074 5 mg, intravenous
    Intervention: Drug: NRX-1074 5 mg
  • Experimental: NRX-1074 10 mg
    NRX-1074 10 mg, intravenous
    Intervention: Drug: NRX-1074 10 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2016)
151
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2014)
60
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02067793
Other Study ID Numbers  ICMJE NRX1074-C-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Naurex, Inc, an affiliate of Allergan plc
Study Sponsor  ICMJE Naurex, Inc, an affiliate of Allergan plc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Naurex, Inc, an affiliate of Allergan plc
PRS Account Naurex, Inc, an affiliate of Allergan plc
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP