Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants
NCT ID: NCT01684163
Last Updated: 2016-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
369 participants
INTERVENTIONAL
2012-11-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo injection
Normal saline
Placebo
Intravenous administration of normal saline into arm.
GLYX-13, 5 mg/kg
Low dose of GLYX-13
GLYX-13 5 mg/kg
Intravenous administration of 5 mg/kg into arm.
GLYX-13, 10 mg/kg
High dose of GLYX-13
GLYX-13 10 mg/kg
Intravenous administration of 10 mg/kg into arm.
Interventions
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GLYX-13 5 mg/kg
Intravenous administration of 5 mg/kg into arm.
GLYX-13 10 mg/kg
Intravenous administration of 10 mg/kg into arm.
Placebo
Intravenous administration of normal saline into arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Naurex, Inc, an affiliate of Allergan plc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Naurex Inc, an affilate of Allergan plc
Locations
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University of Alabama Office of Psychiatric Clinical Research
Birmingham, Alabama, United States
Pharmacology Research Institute
Encino, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pacific Institute of Medical Research
Los Angeles, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, United States
Chicago Research Center
Chicago, Illinois, United States
Evanston Premier Healthcare Research, LLC
Northbrook, Illinois, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States
University of Kansas
Wichita, Kansas, United States
PharmaSite Research , Inc.
Baltimore, Maryland, United States
Bostin Clinical Trials, Inc.
Roslindale, Massachusetts, United States
CRI Lifetree
Marlton, New Jersey, United States
Global Medical Institutes LLC
Princeton, New Jersey, United States
Clinilabs, Inc.
New York, New York, United States
Michael R Liebowitz MD
New York, New York, United States
Finger Lake Clinical Research
Rochester, New York, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
CRI Lifetree
Phildadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center of Dallas
Dallas, Texas, United States
CRI Lifetree
Salt Lake City, Utah, United States
Summit Research Network
Seattle, Washington, United States
Countries
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Other Identifiers
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GLYX13-C-202
Identifier Type: -
Identifier Source: org_study_id
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