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

This study has been completed.
Information provided by (Responsible Party):
Naurex, Inc
ClinicalTrials.gov Identifier:
First received: September 10, 2012
Last updated: January 18, 2015
Last verified: February 2014

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.

Condition Intervention Phase
Major Depressive Disorder
Drug: GLYX-13
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2, Double-Blind, Placebo Controlled, Randomized Withdrawal, Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder

Resource links provided by NLM:

Further study details as provided by Naurex, Inc:

Primary Outcome Measures:
  • Change in Hamilton Depression Rating Scale Score [ Time Frame: 6 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression of Change [ Time Frame: 6 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 371
Study Start Date: October 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo injection
Normal saline
Drug: Placebo
Experimental: GLYX-13, 5 mg/kg
Low dose of GLYX-13
Drug: GLYX-13
Experimental: GLYX-13, 10 mg/kg
High dose of GLYX-13
Drug: GLYX-13


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684163

United States, Kansas
University of Kansas
Wichita, Kansas, United States, 67211
United States, New Jersey
CRI Lifetree
Marlton, New Jersey, United States, 08054
Global Medical Institutes LLC
Princeton, New Jersey, United States, 08540
United States, New York
Michael R Liebowitz MD
New York, New York, United States, 10128
United States, Pennsylvania
CRI Lifetree
Phildadelphia, Pennsylvania, United States, 19139
United States, Utah
CRI Lifetree
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Naurex, Inc
Study Director: Lee Bastin, RN Ed.D. Naurex, Inc
  More Information

No publications provided

Responsible Party: Naurex, Inc
ClinicalTrials.gov Identifier: NCT01684163     History of Changes
Other Study ID Numbers: GLYX13-C-202
Study First Received: September 10, 2012
Last Updated: January 18, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Naurex, Inc:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on March 26, 2015