Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants

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, acute stress 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
• •Women who are planning to become pregnant during the course of the study
• •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 with the exception of GLYX13-C-201.
• •Positive screen for drugs of abuse
• •Have received electroconvulsive therapy, transcranial magnetic stimulation (TMS), or vagal nerve stimulation (VNS) for the current depressive episode
• •Pose 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 who are currently pregnant or planning to become pregnant during the course of the study
• •Dextromethorphan or tramadol since these are serotonin uptake inhibitors
• •History of allergy, sensitivity, or intolerance to N-methyl-D-aspartate receptor \[NMDAR\] ligands