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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684163
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: GLYX-13 5 mg/kg Drug: GLYX-13 10 mg/kg Drug: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 369 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Placebo Comparator: Placebo injection
Normal saline
Drug: Placebo
Intravenous administration of normal saline into arm.
Other Name: Normal Saline

Experimental: GLYX-13, 5 mg/kg
Low dose of GLYX-13
Drug: GLYX-13 5 mg/kg
Intravenous administration of 5 mg/kg into arm.
Other Name: GLYX-13 IV Dose

Experimental: GLYX-13, 10 mg/kg
High dose of GLYX-13
Drug: GLYX-13 10 mg/kg
Intravenous administration of 10 mg/kg into arm.
Other Name: GLYX-13 IV Dose

Primary Outcome Measures :
  1. Change in Hamilton Depression Rating Scale Score [ Time Frame: 6 weeks, 12 weeks, 16 weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression of Change [ Time Frame: 6 weeks, 12 weeks, 16 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01684163

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Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
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Study Director: Medical Director Naurex Inc, an affilate of Allergan plc

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Responsible Party: Naurex, Inc, an affiliate of Allergan plc Identifier: NCT01684163    
Other Study ID Numbers: GLYX13-C-202
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: February 2016
Keywords provided by Naurex, Inc, an affiliate of Allergan plc:
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs