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

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.