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

Phase 2

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: GLYX-13 5 mg/kg
Drug: Placebo
Drug: GLYX-13 10 mg/kg

Registration Number: NCT01684163

Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc

Brief Summary: GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major depressive disorder (depression) who have responded inadequately to another antidepressant drug during the current episode. This trial will assess the effects of GLYX-13 on depression when added to another antidepressant drug that the patient is already taking.

Detailed Description: To evaluate the mean difference in Hamilton Depression Rating Scale 17 (HDRS-17) score for the combined GLYX-13 mean change versus the placebo group mean change at the end of a 6 week randomized withdrawal phase (predose baseline score - score at end of randomized withdrawal period).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 369

Inclusion Criteria

Male and female subjects
Aged 18 to 65 years
Meets DSM-IV-TR) criteria for major depressive disorder (MDD)
Current episode has lasted ≥ 8 weeks before Screening with an inadequate response to all approved antidepressant agent(s) administered at an adequate dose and duration for the current episode
Taking no antidepressant agent currently or taking an SSRI or SNRI
HDRS-17 score ≥ 18 at screening and predose baseline
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 and who do not plan to become pregnant during the course of 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 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 (MDEs) 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, 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLYX-13, 5 mg/kg	GLYX-13 5 mg/kg	Low dose of GLYX-13
Placebo injection	Placebo	Normal saline
GLYX-13, 10 mg/kg	GLYX-13 10 mg/kg	High dose of GLYX-13

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale Score	6 weeks, 12 weeks, 16 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of Change	6 weeks, 12 weeks, 16 weeks

Trial Locations

Locations (22): Evanston Premier Healthcare Research, LLC
🇺🇸
Northbrook, Illinois, United States
Pacific Institute of Medical Research
🇺🇸
Los Angeles, California, United States
Pharmacology Research Institute
🇺🇸
Newport Beach, California, United States
University of Alabama Office of Psychiatric Clinical Research
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Birmingham, Alabama, United States
PharmaSite Research , Inc.
🇺🇸
Baltimore, Maryland, United States
Lehigh Center for Clinical Research
🇺🇸
Allentown, Pennsylvania, United States
Finger Lake Clinical Research
🇺🇸
Rochester, New York, United States
University of Texas Southwestern Medical Center of Dallas
🇺🇸
Dallas, Texas, United States
Atlanta Center for Medical Research
🇺🇸
Atlanta, Georgia, United States
Artemis Institute for Clinical Research
🇺🇸
San Diego, California, United States
Atlanta Institute of Medicine and Research
🇺🇸
Atlanta, Georgia, United States
Chicago Research Center
🇺🇸
Chicago, Illinois, United States
Indiana University Health Neuroscience Center
🇺🇸
Indianapolis, Indiana, United States
Clinilabs, Inc.
🇺🇸
New York, New York, United States
Michael R Liebowitz MD
🇺🇸
New York, New York, United States
Summit Research Network
🇺🇸
Seattle, Washington, United States
University of Kansas
🇺🇸
Wichita, Kansas, United States
Global Medical Institutes LLC
🇺🇸
Princeton, New Jersey, United States
Sarkis Clinical Trials
🇺🇸
Gainesville, Florida, United States
Bostin Clinical Trials, Inc.
🇺🇸
Roslindale, Massachusetts, United States
CRI Lifetree
🇺🇸
Salt Lake City, Utah, United States
Summit Research Network (Oregon), Inc.
🇺🇸
Portland, Oregon, United States