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

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01684163

Run by

Naurex, Inc, an affiliate of Allergan plc

People needed

369

Starts

2012-11-01

Expected to finish

2014-06-01

Last updated by the study team

2016-03-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• History of allergy, sensitivity, or intolerance to N-methyl-D-aspartate receptor [NMDAR] ligands

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.