Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants
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
1 other identifier
interventional
369
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Nov 2012
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2012
CompletedFirst Posted
Study publicly available on registry
September 12, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 17, 2016
February 1, 2016
1.4 years
September 10, 2012
February 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hamilton Depression Rating Scale Score
6 weeks, 12 weeks, 16 weeks
Secondary Outcomes (1)
Clinical Global Impression of Change
6 weeks, 12 weeks, 16 weeks
Study Arms (3)
Placebo injection
PLACEBO COMPARATORNormal saline
GLYX-13, 5 mg/kg
EXPERIMENTALLow dose of GLYX-13
GLYX-13, 10 mg/kg
EXPERIMENTALHigh dose of GLYX-13
Interventions
Intravenous administration of 5 mg/kg into arm.
Intravenous administration of 10 mg/kg into arm.
Intravenous administration of normal saline into arm.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
University of Alabama Office of Psychiatric Clinical Research
Birmingham, Alabama, 35294, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pacific Institute of Medical Research
Los Angeles, California, 90024, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, 30328, United States
Chicago Research Center
Chicago, Illinois, 60634, United States
Evanston Premier Healthcare Research, LLC
Northbrook, Illinois, 60201, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46201, United States
University of Kansas
Wichita, Kansas, 67211, United States
PharmaSite Research , Inc.
Baltimore, Maryland, 21208, United States
Bostin Clinical Trials, Inc.
Roslindale, Massachusetts, 02131, United States
CRI Lifetree
Marlton, New Jersey, 08054, United States
Global Medical Institutes LLC
Princeton, New Jersey, 08540, United States
Clinilabs, Inc.
New York, New York, 10019, United States
Michael R Liebowitz MD
New York, New York, 10128, United States
Finger Lake Clinical Research
Rochester, New York, 14618, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
CRI Lifetree
Phildadelphia, Pennsylvania, 19139, United States
University of Texas Southwestern Medical Center of Dallas
Dallas, Texas, 75235, United States
CRI Lifetree
Salt Lake City, Utah, 84106, United States
Summit Research Network
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Naurex Inc, an affilate of Allergan plc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2012
First Posted
September 12, 2012
Study Start
November 1, 2012
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
March 17, 2016
Record last verified: 2016-02